Clinical Trial Insights from the WCG Knowledge Base™

The WCG Trial Insights series brings you weekly insights on trial activity throughout the COVID-19 crisis and recovery, powered by the WCG Knowledge Base.

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Insights from August 27, 2021

Sites’ Ranking of Most Important Protocol and Planning Attributes of Sponsors, CROs

Strong protocols that are well-balanced between scientific theory and clinical practice reality top the list of sponsor/CRO attributes most important to sites when it comes to study design and planning, according to a recent CenterWatch survey. Of 351 respondents, 64 percent named “Provides good overall protocol design” as very important. “Provides timely drug delivery” was named very important by 62 percent, and 60 percent of respondents chose “Has protocols in which scientific rationale is aligned with clinical practice realities.”

Of less importance to sites were “Provides patient recruitment planning and assistance” with 44 percent and “Actively engages patients/patient groups in protocol design” at 42 percent.

Chart of Sites' Top Sponsor/CRO management attributes

Insights from August 20, 2021

Sites’ Ranking of Most Important Management Attributes of Sponsors, CROs

Excellent CRAs, organization and open communication top the list of what sites believe are the most important attributes of sponsors and CROs, according to a recent CenterWatch survey. Of 184 respondents, 67 percent named “Has professional, knowledgeable and well-trained monitors/CROs” as very important, followed by “Is organized and prepared” at 66 percent and “Maintains open communication” at 64 percent.

At the bottom of the ranking of attributes were “Has a supportive culture” and “Adequately empowers staff to make level-appropriate decisions,” with only 48 percent of respondents each rating them as very important.

Chart of Sites' Top Sponsor/CRO management attributes

Insights from August 13, 2021

Survey Ranks Seven Top Strategies Sites Used to Keep Trials Open During COVID

Remote monitoring/source data verification (SDV) topped the list of strategies sites found most valuable in keeping their trials open during the COVID-19 pandemic, according to a recent CenterWatch survey. Asked to rank seven strategies in order of importance, more than 30 percent of sites responding to the survey selected remote monitoring/SDV as the most important, followed closely by direct-to-patient shipment of investigational products and trial supplies at 26 percent. Only 4 percent named wearable devices as the most important strategy.

Chart: Sites' Ranking of Sponsor-Provided Strategies for Continuing Operations During the COVID-19 Pandemic

Insights from July 23, 2021

Endpoints Play a Crucial Role in CNS Trial Design

Last month, we highlighted that CNS trial starts had rebounded from the dip experienced in the first half of 2020. This week, we look deeper into CNS trial trends with a focus on the most frequent primary endpoints used in Phase II and Phase III clinical trials.

In the US alone, it’s estimated that more than 1 million people are living with Parkinson’s disease, more than 5 million are living with Alzheimer’s disease, and nearly 40 million adults are affected by anxiety disorders each year.

Exacerbating this issue is the 85% failure rate of CNS drugs in Phase II and Phase III clinical trials, which deprives patients of new potential treatments. Industry experts frequently point to poor study design and subjectivity in endpoints whether related to variability in the reporting by patients or investigators, reliance on caregiver assessments, or placebo responses as top reasons for trial failure.

 

Chart: most frequent primary endpoints in Phase II and Phase III industry-sponsored CNS clinical trials

Insights from July 16, 2021

Immuno-Oncology Therapies Continue to be a Top Focus in Phase II and Phase III Trials

In our ongoing analysis, WCG experts provide a deeper view into the leading mechanisms of action driving the dynamic Phase II and Phase III clinical trials landscape in the US.

Immuno-oncology therapies continue a successful journey from early phase clinical trials to randomized controlled trials and remain as the leading mechanism of action; our experts suggest that this success will encourage the development of molecularly targeted treatments for other diseases. Focus on cellular and genetic targets and immune related responses to therapies has fueled the oncology pipeline with the increasing interest in combination therapies and precision medicine. Combination options will continue to be explored, combining therapeutic agents as well as multimodality therapies, including novel surgical and radiotherapy approaches, creating new levels of patient subpopulations, each with a different possible response.

The abundance of new agents has led to innovative trial designs, adding complexity in oncology trials with a resultant increase in patient and site burden. Sponsors are increasingly aware and are actively seeking the patient voice in every aspect of the clinical trial design process. Frequency of visits, use of digital health, patient concierge services, less invasive procedures all support a focus on patient-centered trials.

Insights from July 9, 2021

COVID-19 Drove Dynamic Change in Trial Starts in Many TAs;
Overall Trial Starts Up 8% in U.S.

The number of US industry-sponsored clinical trial starts increased overall by 8% in 2020, driven by robust growth in infectious diseases and oncology.

The growth in infectious disease trials focused primarily on COVID-19, while the growth in oncology was more evenly spread among various types of cancer.

Infectious disease trial starts numbered nearly 500 in 2020, compared with just fewer than 200 in 2019. Oncology drugs accounted for a 23 percent share of all drugs in clinical development in 2020 with nearly 1,200 trial starts, compared to 1,000 trial starts in 2019.

Chart of trial starts by year for 2016-2020 in the U.S.

Insights from July 2, 2021

Site Trends Show Increases in Trial Centers, Decrease in Medical Practices, Hospitals

As reported in CenterWatch Weekly, clinical research sites are facing an unprecedented bottleneck as they juggle restarting non-COVID-19 trials, continue ongoing COVID-19 trials and return to their prepandemic plans for new trials in 2021. That leads us to ask, how will the evolving clinical research site landscape adapt?

One notable trend is the shift in which type of sites are actively engaging in Phase II and Phase III industry-sponsored clinical trials. Dedicated clinical trial centers have increased their trial percentage share in each of the last five years, while medical practices and academic hospitals have exhibited downward trends.

Insights from June 25, 2021

Clinical Trial Starts Rebound for Oncology and CNS

In our continuing analysis of the clinical trial landscape, WCG experts have looked at the trends of trial starts compared to trial start means over the previous three years in the four top therapeutic areas for clinical trials.

After two quarters of decline in 2020, oncology trial starts rebounded in the third quarter, but dropping in the fourth quarter with a slight increase into the first quarter of 2021.

For CNS, trial starts dipped in the first and second quarters of 2020, rebounding in the third quarter and peaking in the fourth quarter, dropping slightly but remaining above the mean.

Infectious disease trial starts jumped significantly in 2020 over the previous two years with the onset of COVID-19, declining in the first quarter of 2021.

Cardiovascular trial starts remain below the mean for 2019, 2020 and into the first quarter of 2021.

Chart of clinical trial starts for the past three years for Oncolgy, CNS, Infectious Diseases and Cardiovascular studies.


Insights from June 18, 2021

Clinical Trial Professionals Have Concerns About Industry Preparedness for Innovation and Change

Nearly half of sponsors and CROs surveyed recently said they were comfortable keeping their own work skills up to date but only a third were comfortable about their organization’s workforce as a whole to do so.

At least a third were uncomfortable with their organization’s procedures for managing clinical trial quality in the context of innovation and for evaluating whether and when to deploy innovations in clinical development, said the survey conducted by WCG Avoca.

Even more were uncomfortable with their organization’s ability to assess the ROI of innovations at 38 percent and with clinical trial worker’s understanding of the quality implications of the changes being made.

Chart showing survey results on concerns about workforce and corporate innovation readiness


Insights from June 11, 2021

Survey Shows Variances in Adoption of Risk Management At Sites

Clinical trial sites were most likely to have adopted remote data source review, remote data source verification and remote review of electronic investigator site files during COVID-19, according to a recent survey by WCG Avoca.

Seventy percent of clinical trial sites adopted risk-based monitoring and study management tools and 50 percent had adopted centralized remote monitoring before COVID-19, the survey showed.

At the same time, 58 percent said they did not plan to use artificial intelligence to detect possible adverse events that may not have been reported and 32 percent said they did not plan to automate work flows.

Chart: Use data management, risk management, and monitoring tools.


Insights from June 4, 2021

Ship-To-Home Clinical Supplies Top List of Innovations Adopted During Pandemic

Trial innovations most likely to have been adopted because of the pandemic included ship-to-home of clinical supplies at 47%, study visits by telemedicine at 40% and hybrid trials at 33%, a recent survey by WCG Avoca has shown.

Home health care provider study visits were adopted by 32% of those surveyed and portals providing patient-facing information were adopted by 22%.

According to WCG Avoca, most respondents felt that decentralized activities helped retention and diversity of study participants and streamlined clinical development programs, but about 25% felt that decentralization posed substantial risks to protocol compliance and study participant safety and privacy.


Insights from May 28, 2021

Non-Traditional Study Designs Have Mixed Acceptance Post-Pandemic, Survey Shows

More than half of sponsors and providers in a recent survey conducted by WCG Avoca said they had no plans to use synthetic control arms in future studies and more than a third also said they did not plan to use novel digital endpoints. Most of the sponsors and providers surveyed also said they had begun to use non-traditional study designs before COVID-19 and only 5% to 15% had adopted them because of it.

Most of those surveyed reported that they had already begun to use adaptive trials, observational real-world data trials and precision medicine trials before the pandemic. The primary drivers for using non-traditional study designs were accelerating timelines for individual clinical trials and clinical development programs as a whole and to increase the relevance of clinical trial data to real-word patients. The primary challenge reported in not using innovative trial designs were regulatory concerns as well as concerns about risk.


 

Insights from May 21, 2021

COVID-19 Trial Progress Tracker Shows 172 Completed Studies

A total of 799 global industry-sponsored clinical trials for COVID-19 have been planned since early 2020, and 644 of those now have a documented start date. Of the trials that have started, 172 have been completed, with results reported publicly for 61 of the 172 (35%) but not reported for 111 (65%).

We hope to see more of these studies move into the “results reported” category, as shared results will continue to move the overall field of knowledge of COVID-19 forward.


Insights from May 14, 2021

Most Sponsors of COVID-19 Studies Have Launched Only One Trial

Of industry-sponsored clinical studies with at least one site in the U.S., 14% of the studies are observational, 24% are studies of diagnostics (laboratory tests and clinical diagnostic devices) and 62% are clinical trials.

Nearly 73% of the 268 biopharma companies sponsoring clinical trials for COVID-19 prevention or treatment have initiated only one trial since March 2020. That group includes sponsors that had approved products or products in development for other indications and launched trials to see if their agents had efficacy against COVID-19, as well as new development programs moving into the clinic with targeted agents.

Only 22% of those sponsors have started two to four clinical studies and only 5% have initiated five or more clinical trials for COVID-19, all with one or more agents.


Insights from May 7, 2021

COVID-19 Clinical Trial Starts Shift Focus from 2020 to 2021

Since early 2020, we have been following new clinical trial starts for COVID-19. In 2020, most early clinical trials involved agents intended to mitigate the overwhelming immune reaction to the virus associated with hospitalization and severe disease. Almost all of those agents were in development or approved for other indications and were being repurposed for COVID-19.

In 2021, we have seen a shift in the proportion of different types of agents in clinical trials. While agents to mitigate clinical impact are still being explored, their share of trial starts dropped from 62% in 2020 to 39% in 2021.

At the same time, the share of trial starts for vaccines grew from 9% in 2020 to 27% in 2021. The share of trial starts for post-COVID 19 symptoms or focused on early infection to prevent progression to severe disease, which are largely antiviral agents, has remained stable. Because there has been added time for pre-clinical development, more of these agents are specifically targeted against the SARS-CoV-2 virus rather than being repurposed from other indications.

COVID-19 clinical trials comparison, 2020 to 2021


Insights from April 23, 2021

Majority of Oncology Sites Report Meeting Study Startup Timelines of Less Than 120 Days

A WCG survey conducted in April shows that 50 percent of the sites reporting data meet study startup timelines, as defined by the time between protocol delivery to the institution to trial activation, of between 61 and 120 days.

Twenty-five percent of the sites report meeting that timeline in 121 days or more and 20 percent report meeting that timelines in 60 days or less. Five percent do not measure their start up timelines.

Chart of survey results: startup timeline for Oncology trials (from protocol delivery to institutions to trial activation)


 

Insights from April 16, 2021

Sites Say Enrollment and Staffing Top Their List of Concerns

Trial enrollment and staffing topped sites’ list of concerns in a survey conducted this week by WCG.

Nearly 60 percent of the sites surveyed said trial enrollment was their top concern, followed by staffing and defining what “new normal” operations would be post-COVID.

Enrollment was also the top concern in a survey WCG conducted in July 2020, at 68 percent. Staffing, however, was ranked as a top concern by only 10 percent of sites last year, compared with 49 percent this year.

Chart: What are the top issues impacting your site today?


Insights from April 9, 2021

Sites Continue to Embrace New Solutions As Trial Landscape Shifts

Nearly three-quarters (73%) of sites recently surveyed reported they plan to continue using telemedicine after the pandemic subsides, a major jump from the 12% that said they used virtual visits before the pandemic made them necessary.

Almost two-thirds (61%) of sites said they plan to continue using remote coordinators after the pandemic. Pre-pandemic, only 15% used remote coordinators.

Remote trial monitoring also is seeing an upward trend, with the number of sites that would allow sponsors or CROs to conduct remote monitoring jumping to 93% from the pre-COVID level of 74%.

Chart of clinical research site survey shows rapid shift in acceptance of virtual solutions.


 

Insights from March 26, 2021

Trials Rebound to Two-Year High in Q4 2020

In the first half of 2020 the number of clinical trials started in the U.S. dropped sharply, as the effects of the COVID-19 pandemic were felt. In Q3, the number of clinical trial starts began to rebound with a 16.2 % increase over the same quarter in 2019. In the fourth quarter of 2020 the number of starts increased further, with a 7.5% increase over the prior year.


 

Insights from March 12, 2021

Diagnostic Studies Represent 31% of COVID-19 Studies in U.S.

While most industry-sponsored clinical studies for COVID-19 being conducted in the U.S. are clinical trials evaluating agents or devices for the treatment or prevention of disease, almost a third of the studies in process are assessing diagnostic tests.

About 10% of the diagnostic studies are for the collection of samples (blood, saliva, nasal swabs) from COVID-19 patients or other study populations to create biobanks from which samples can be used to develop and validate tests. Eighty-three percent of diagnostic studies are assessing the accuracy and test characteristics of tools to look for current or past SARS-CoV-2 infection (PCR, antigen, and antibody tests). About 7% of the studies are looking at tools to be used for clinical diagnostics; including devices to monitor changes in voice characteristics, and a hand-held ultrasound device to look at patterns in lung congestion, both of which may indicate SARS-CoV-2 infection.


 

Insights from March 5

Pie chart of Industry-Sponsored U.S. Clinical Trials for COVID-19, Initiated or Planned Since Early 2020, broken out by study purpose. Mitigate Clinical Impact leads at 56%, followed by Antiviral (30%), Vaccine (12%) and Post-COVID Symptoms (2%).

COVID-19 Trial Purposes Continue to Diversify

Early in the pandemic, the vast majority of clinical trials for COVID-19 were testing agents to mitigate the clinical impact of disease, usually in severely ill and hospitalized patients. Over the course of the pandemic, we’ve seen that distribution shift. We continue to see new studies of prophylactic vaccines, and continued exploration of agents intended to act primarily as direct antiviral agents (including antibi-based therapies). We also note the growth of a category that first appeared about eight weeks ago, which is clinical trials to treat post-COVID or “long COVID” symptoms.

Pie chart of Industry-Sponsored U.S. Clinical Trials of preventative vaccines for COVID-19, broken out by mechanism.

COVID-19 Vaccine Trials Expand to New Populations and Agents

The increasing number of vaccine trials represents both new agents entering clinical testing, and expanded study populations for agents that were already in trials; for example, the addition of trials in pregnant women and in children. We also continue to see that a wide variety of vaccine platforms and mechanisms are being investigated.


Insights from February 26, 2021

CIR Submissions Show Ongoing COVID-19-Driven Adjustments to Studies

Through 2020, we tracked Changes in Research (CIR) submissions, including protocol amendments and other adjustments. In the spring of 2020, we saw the sudden surge of COVID-19-related CIRs as sponsors and researchers quickly adjusted research plans with shifts to virtual study visits, remote measurement of study endpoints, and modifications to informed consent processes, peaking at a high of 58% in April. By the end of 2020, we saw about 5% of CIRs tracked as COVID-19-related; the majority of which are for protocols where COVID-19 is the indication being studied.

However, we do see a small number of studies continuing to adjust operationally around changing pandemic precautions, shifting study visits and assessments from remote and virtual encounters back to in-person visits, if the protocol had not initially been amended to allow that flexibility.

Chart showing the share of COVID-19 and Non-COVID-19 Study Starts by month. The percentage of Change in Research (CIR) submissions related to COVID-19 peaked in April, at 58% of total CIRs, data from WCG’s Knowledge Base™ show. CIRs were driven by shifts to telemedicine and the shipment of drugs directly to study participants, among other factors. COVID-19-related CIRs represent just 5% of January 2021 CIRs.


Insights from February 5, 2021

Using Data to Optimize Site Selection and Patient Diversity

The past year has brought new attention to the important issues of diversity in clinical research, and in ensuring that populations of study participants appropriately represent the demographics of the overall patient population. That often means that sponsors need to consider where to open study sites so they are accessible to diverse populations with the disease of interest.

As an example, in the maps below, the darker-shaded counties have higher racial and ethnic population diversity and a higher prevalence of Alzheimer’s disease. The red pins denote clinical sites conducting new studies in Alzheimer’s disease within the last three years. As evident in the maps, geographical distance will prevent many Alzheimer’s disease patients from the most diverse areas from participating in these studies.

Using data like this during the study startup process can help guide site selection (primary or satellite sites), prompt the incorporation of decentralized trial elements to allow a larger area of participation, or to add site resources to assist study participants with logistic arrangements to allow them to travel to the research sites.

Graphic showing maps of three states (Oregon, Georgia and Louisiana) with color scale of their relative diversity and prevalence of Alzheimer's Disease by county, with locations of Alzheimer's Disease study sites during the last three years.


Insights from January 29, 2021

COVID-19 Trial Progress Tracker Shows 91 Completed Studies

A total of 639 global industry-sponsored clinical trials for COVID-19 have been announced since early 2020, and 490 of those now have a documented start date. Of the trials that have started, 91 have a current status of “completed,” with results reported publicly for 28 of the 91 (31%) but not reported for 63 (69%). We hope to see more of these studies move into the “results reported” category, as shared results will continue to move the overall field of knowledge of COVID-19 forward.

Chart: progress tracker for global industry-sponsored COVID-19 studies.

 


 

Insights from January 22, 2021

Mitigating the Clinical Impact of COVID-19: Immune Mediators Still Dominate, but Number of New Agents Being Tested Increasing

In early 2020, the initial burst of clinical trials for agents to combat COVID-19 was focused on mitigating the clinical impact of infection, including the process of immune system overactivation that was thought to be the mechanism of physiologic injury in moderate/severe disease. Therefore the agents being tested were predominantly immune mediators – products that were approved or in development for other conditions, being quickly repurposed to look at their use against COVID-19.

As we enter 2021, 63% of industry-sponsored clinical trials are testing agents designed to mitigate the disease’s clinical impact. Within that range, we continue to see a large number of immune-mediating agents being studied. However, we have seen an increase in the number of agents intended to specifically support lung function, block thrombotic processes and protect blood vessels, and to assess the role of the microbiome. With continued improvement in our understanding of the process of disease, we will likely see the spectrum of agents being tested for treatment continue to diversify.

Chart of U.S. industry-sponsored clinical trials to mitigate the clinical impact of COVID-19, by primary mechanism of action.


Insights from January 15, 2021

Veterans Health Administration: Leading the way in Infrastructure and Expertise for Diverse, High-Quality Clinical Trials

This week we’re reflecting on our compelling conversation with the Veterans Health Administration during our webinar on 1/13, discussing how VHA research is enabling relationships with external partners through investment and process improvements to make access to high-quality clinical trials easier for Veterans.

The VHA is America’s largest Learning Healthcare System, with more than 9 million beneficiaries (26% non-white). The VHA’s Office of Research and Development (ORD) is an integral component in driving the enterprise functions of its research mission. VHA has a long history of conducting massive, high-impact clinical trials.

WCG recently announced that ORD is successfully implementing WCG’s IRBNet electronic submission and review system nationwide, for more than 100 VA medical centers (VAMCs) that have research programs.

 

Map of VA Innovation and Research Review System sites across the U.S.


Insights from January 8, 2021

COVID-19 Trials Dominated By Research on Mitigating Clinical Impact

As we enter 2021, more than 240 industry-sponsored clinical trials have been initiated in the U.S. to address the COVID-19 pandemic. Among those, almost two-thirds are testing agents designed to mitigate the disease’s clinical effects.

The second largest grouping are COVID-19 clinical trials that are testing agents with a primary antiviral effect (29%). Within that group, trials studying direct-acting antiviral therapies represent 51% of antiviral trials, followed by antibody-based therapies (42%), dietary supplements (3%), convalescent plasma (1%), and other mechanisms (3%).

The remaining trial groups include vaccines (7% of all initiated COVID-19 trials in the U.S.) and trials studying treatments for post-COVID-19 symptoms (1%).

Chart on COVID-19 trials in the U.S., with 63% in the category "Mitigate Clinical Impact"

Pie chart showing planned U.S. Industry sponsored COVID-19 trials in the U.S. by purpose of study.

More Than 70 Planned COVID-19 Trials in the U.S. Yet To Initiate

There are 71 industry-sponsored clinical trials for COVID-19 currently being planned in the U.S., many with lapsed start dates. Of the total, 38 are focused on mitigating clinical impact, 22 are designed to test antiviral effect, 9 are vaccine trials, and 2 are to address post-COVID-19 symptoms.


Insights from December 11, 2020

We’ve published 35 weekly issues in our Trial Insights series this year – bringing you current and unique data and insights on trial activity throughout the COVID-19 crisis. The insights are based on the extensive services we provide to life science clients and supported by our proprietary and powerful WCG Knowledge Base™.

As we near the end of 2020, we’re taking a look back at the observations that gathered the most engagement from our readers throughout the year, now updated with data through November.

COVID-19 Case Count and Trial Activity by State: March to November

We first published an animated view of the spread of COVID-19 cases by state compared against the number of clinical studies in October of this year. We’ve updated our view of the pace of case counts and sponsored studies by state in the chart below, featuring data through November 2020.

 

 

Backlog of New Study Starts Continues to Grow Significantly

In June, we first examined a growing backlog of study starts resulting from the early days of the pandemic’s impact, with a significant number of studies that had indicated start dates but had not begun.

As we near year-end we continue to see a trend of planned start dates that have been missed, demonstrating the disruption that the pandemic has had on clinical development plans and timelines, and a backlog that will carry into 2021.

Surge in New Investigators Conducting COVID-19 Research

When we first published the data below in July of this year, we noted an increase in the number of new investigators added by therapeutic area. In the first half of 2020, there was a notable increase of 25% in new infectious disease investigators from all of 2019, which aligned to new investigators wanting to help solve the ongoing crisis and the rapid increase in research opportunities from sponsors or other organizations.

We’re taking another look to now include data through November 2020 – and can see an even more dramatic increase of 118% in new infectious disease investigators from all of 2019, which is in keeping with a historic trend of physicians participating in clinical research for the first time during health crises.


Insights from December 4, 2020

After Midyear Uptick, 2020 Trial Starts Still Lagging Prior Years

As previously reported, industry-sponsored global trial starts have shown a distinct decrease in 2020 from prior-year study starts, even in the months preceding the impact of the COVID-19 pandemic. When we last analyzed data through July, we saw a slight rebound occurring during the summer, as research centers began to reopen. However, in refreshing data through the end of October, we see a marked trend downwards, possibly aligned with a second wave of COVID-19 spread in the U.S. and globally in the fall.

Interestingly, as early as January 2020, the number of study starts globally was lower when compared to typical January starts from 2015 through 2019. The COVID-19 pandemic then affected what appears to be a typical increase in study starts in February and March from prior years.

Emerging Bio and Partnerships Dominating Industry-Sponsored COVID-19 Trials

Of the 571 industry-sponsored, global interventional COVID-19 trials, 91% are now led by emerging and small pharmaceutical companies, a growth of three percentage points since August.

Uncertainty Persists In 2020 Planned Trial Activity

According to industry-reported data (including COVID-19 and non-COVID-19 trials), more than 2,200 studies that were originally planned to initiate by the end of November are still showing a status of planned and yet-to-be initiated. Though overall 2020 study start volumes are down versus 2019, almost 6,500 were initiated from January through November. We’ll continue to track this data, as sponsors navigate uncertainty and update trial status and plans accordingly.


Insights from November 20

Most COVID-19 Physiologic Studies Focused on Immunologic Correlates and Responses

We reported previously that 13% of industry-sponsored COVID-19 studies are observational. While most industry-sponsored research are clinical trials, industry sponsors are also collecting data to look at a number of epidemiologic and physiologic questions. In many cases, that data may help support future investigations using real-world data or may provide insight to help develop future therapies or screening programs and diagnostic tests.

Studies of the physiology of COVID-19 are aimed at better understanding risk factors and the biologic effects of infection to support the development of preventive and therapeutic measures. Researchers are looking at the assessment of immunologic correlates and responses (53%), genome sequencing and genetic factors (24%), the microbiome (12%) and coagulopathy correlates and responses (12%).

COVID-19 Trial Progress Tracker Shows 39 Completed Studies

WCG continues to track the progress of global interventional industry-sponsored COVID-19 trials that have been reported as planned/initiated so far this year, now numbering 487. Of those, 39 have been reported as complete, with five completing in the past five weeks. To date, six studies have reported meeting their primary endpoint, with another five reporting they did not meet their endpoint. Notably, 139 studies are still planned for initiation in 2020, so this data will continue to reflect additional activity.


Insights from November 13

Epidemiology Studies Comprise 67% of COVID-19 Observational Studies

We reported last week that 13% of industry-sponsored COVID-19 studies are observational. While most industry-sponsored research are clinical trials, industry sponsors are also collecting data to look at a number of epidemiologic and physiologic questions. In many cases, that data may help support future investigations using real-world data or may provide insight to help develop future therapies or screening programs and diagnostic tests.

Of all COVID-19 observational studies, two-thirds are epidemiologic. Among those, most are characterized as Screening Protocols (19%) and Long-Term Outcomes Registries (19%), followed by Modeling and AI Development (16%) and Real-World Data Collection (16%).

Change in Research Submissions Nearing Pre-COVID-19 Levels

The number of Change in Research (CIR) submissions related to COVID-19 peaked in April, at 58% of total CIRs, data from WCG’s Knowledge Base™ show. CIRs were driven by shifts to telemedicine and the shipment of drugs directly to study participants, among other factors. COVID-19-related CIRs continued to decline through September, representing just 8% of September CIRs.

COVID-19 Studies Represented 25% of Study Starts During Peak in April

It’s interesting to examine the relative composition of COVID-19 studies versus non-COVID-19 studies over the course of this year. April represented the highest share of COVID-19 study starts so far, with COVID-19 studies at 25% of total study starts. COVID-19 studies continue to be planned and started, representing 15% of all study starts in October.


Insights from November 6

Immune Mediators Continue to Dominate COVID-19 Trials as Industry Explores New Options

Of the agents being studied that are intended to mitigate the clinical impact of viral infection and decrease the severity of COVID-19, most studies have focused on immune system mediators, but many different mechanisms are being explored. We can see the rapid expansion of the number of studies across an array of agents over seven months. Immune mediators (of various types) continue be the largest category of products being studies, with stem cells and agents intended specifically to improve or support lung function taking second and third place respectively.

380 Industry-Sponsored U.S. COVID-19 Studies In Process

The number of industry-sponsored COVID-19 trials running in the U.S. increased 28% since July. We’re keeping an eye on total volume, as well as trial types, as we continue to monitor industry efforts to mitigate the pandemic.

2020 Planned U.S. Non-COVID-19 Trials Delayed Six Months on Average

Of the 225 non-COVID-19 industry-sponsored U.S. studies that have or had an original planned start date in 2020, 50% initiated at least one delay to their timelines, with a mean delay of six months. Of the more than 2,500 industry U.S. trials planned or starting in 2020, approximately 65% showed some delay from their original plan, with a mean delay of approximately 2.6 months.


Insights from October 30

Healthy Volunteer Clinical Studies Show Signs of Recovery

As last reported in July, the conduct of healthy volunteer clinical studies was impacted by the COVID-19 pandemic. In this assessment of global, currently active clinical studies, we can see that the number of study starts began to increase in the second quarter, which has continued into the third quarter.

More Than Half of Industry Sponsored COVID-19 Trials Include Clinical Sites in North America

There are 607 ongoing industry-sponsored clinical trials for indications related to COVID-19. The chart shows the number of trials in each global region; if a trial has clinical sites in multiple regions, it is counted in each one. Due to the global nature of the pandemic, multi-regional studies are common and important in developing COVID-19 therapies.

Study Startup at Sites Shows Faster Turnaround Times for COVID-19 Trials

Data from WCG PFS indicates there has been significant progress in turnaround times for study startup at sites for COVID-19 trials. In many cases, initial deliverables were turned around within 24 hours of request, with full contract negotiation completed in 2 to 3 business days of request, showing ability to address the urgent global pandemic and help sponsors meet tight deadlines.


Insights from October 23

12 Repurposed Agents Are Currently Being Tested For COVID-19 Efficacy

There are 12 agents currently in COVID-19 trials that were originally studied for other conditions and potential uses. Those products are currently in 43 monotherapy and 12 combination COVID-19 trials that have been initiated, and 12 monotherapy and 3 combination trials planned.

 

Multiple Vaccine Technologies Being Studied for COVID-19

An increasing number of vaccines are in clinical trials for the prevention of COVID-19. Some of the vaccines are modifications of platforms that are the basis of previously approved vaccines for other infectious diseases. Others, like the mRNA-based vaccines, are new vaccine technology.


Insights from October 16

COVID-19 Case Count and Trial Activity by State: March to October

At WCG, we’re continuing to monitor the intersection of confirmed cases and study volumes across the U.S. In the animation below, we plot the growth of both COVID-19 cases and studies from late March through mid-October, at a state level.

While New York’s case counts advanced quickly in the early days of the virus (March/April), we can also see study activity ramping up in Florida, California and Texas, possibly in anticipation of case growth in those states. These three states ultimately surpassed New York in COVID-19 studies by May, and then cases by August. As sponsors consider new study starts, the pace of the virus moving among states will continue to be a factor in site selection.

 

COVID-19 Trial Progress Tracker Shows 10 Trials Reporting Outcomes

WCG continues to track the progress of global interventional industry-sponsored COVID-19 trials that have been reported as planned/initiated so far this year, now numbering 471. Of those, 34 have been reported as complete, with 15 completing in the past six weeks. To date, six studies have reported meeting their primary endpoint, with another four reporting they did not meet their endpoint. Notably, 137 studies are still planned for initiation in 2020, so this data will continue to reflect additional activity.


Insights from October 9

In our continuing analysis of the clinical trial landscape and the impact of COVID-19, we’ve looked at the trends of trial starts as compared to trial start means over the past three years, corrected by quarterly variations.

As previously reported in this email series, we’ve seen a significant dip in overall trial starts in 2020. This week, we’re taking a deeper look at the top therapeutic areas associated with the largest number of clinical studies.

In all charts, “0” reflects the mean number of study starts in that quarter in the prior three years.

As seen below, interesting patterns emerge as we evaluate how the surge in infectious disease study activity has surpassed more established trends associated with the top therapeutic area study starts in the past three years.

Oncology and CNS studies appeared somewhat stable prior to COVID-19, but new starts of infectious disease and cardiovascular studies were both trending down before the pandemic.

Oncology Studies

While oncology study starts declined in 2020 due to the COVID-19 pandemic, it is anticipated that the number of starts will return to levels consistent with 2018-2019 as study starts that were delayed due to COVID-19 ultimately recommence.

CNS Studies

CNS studies show a dramatic dip in trial starts this year, as compared to the rolling three year mean.

Cardiovascular Studies

The number of trial starts in cardiovascular indications was already decreasing prior to the current crisis, but showed the steepest decline in starts in 2020.

Infectious Disease Studies

We see a dramatic increase of infectious disease trial starts—largely due to COVID-19 trials—during the current pandemic, even though trial starts in this therapeutic area had been steadily decreasing in prior years.


Insights from October 2

Treatment Trials Show Highest Traffic in COVID-19 Trial Listings

Of the top 100 COVID-19 clinical trial listings attracting the most views on WCG CenterWatch iConnect from June through September, 56% were treatment related and 25% were vaccine trials, representing a slight increase in both trial types since we last reported this data more than a month ago. Vaccines continue to have disproportionately more interest than their percentage share of total listings, which continues to reflect public interest in vaccine development.

Most Agents in Clinical Trials for COVID-19 are Intended to Mitigate Clinical Impact

Almost two-thirds of the U.S. industry-sponsored clinical trials begun for COVID-19 are testing agents designed to mitigate the disease’s clinical effects, while 28% are testing antivirals and 9% are testing vaccines.

Immune Mediators Remain Primary Product Type for COVID-19 Trials

Of the agents being studied to determine whether they mitigate the clinical impact of COVID-19, potential mediators of the immune system continue to represent the majority (62%) of those being studied. In addition, 10% of the studies are looking at products intended to improve or support lung function in severe infections, and another 10% are evaluating the effect of stem cells.


Insights from September 25

Traffic to Clinical Trials Listings Continue to Show Increased Interest in COVID-19

According to data from WCG CenterWatch iConnect, COVID-19 trial listings not only remain the most-visited listings as of September, but have jumped significantly since we last reported data. Starting in April, WCG CenterWatch iConnect has seen a continual increase in the percentage of traffic related to COVID-19, with COVID-19 trial listings representing 15.1% of total visits as of July, rising to 30.1% of traffic since. That aligns to continued public awareness and interest in trial progress, as well as progress of vaccine candidates moving into more advanced phases of development.

COVID-19 Trial Locations Steady; Virus on the Move

This week’s data show that even as states with the fastest-growing number of cases shift over time, states with the highest number of active COVID-19 trials has remained the same since the initial peak of the pandemic earlier this year.

Total 2020 Trial Starts Lagging Prior Years

As we’ve been tracking, industry-sponsored global trial starts show a distinct decrease from prior-year study starts, even in the months preceding the impacts of the COVID-19 pandemic. The view below compares each month’s increase or decrease to the average of the prior three years. Though some recovery of trial activity is evident in 2020, we have yet to see a rebound that parallels prior year volumes.


Insights from September 18

Downward Trend in New Principal Investigator Trial Participation

Data from the WCG Knowledge Base™ confirm recently reported downward trends in new principal investigator trial participation. From 2015 to 2019, we saw a 48% decrease in principal investigators participating for the first time in industry-sponsored trials. This trend will be important to watch as we face a mounting backlog of trials in 2020 and beyond.

Total 2020 Trial Starts Lagging Prior Years

Industry-sponsored global trial starts show a distinct decrease from prior-year study starts, even in the months preceding the impacts of the COVID-19 pandemic. As early as January 2020, the number of study starts globally was lower when compared to typical January starts from 2015 through 2019. The COVID-19 pandemic then impacted what appears to be a typical increase in study starts in February and March from prior years; whereas in 2020 we see a marked increase in June and July starts, as research centers began to reopen.

 

Infectious Disease The Only Therapeutic Area Showing Growth in Trial Starts for 2020

WCG is tracking trial starts by therapeutic area for quarters one through three of 2020 versus 2019. Even with overall trial start volumes down versus 2019, we do see an unsurprising uptick in the growth of infectious disease trial starts in 2020 versus other categories.


Insights from September 11

Nucleic Acid-based Products and Immune Mediators Dominate COVID-19 Vaccine Development

Nucleic Acids dominate the agents being studied in COVID-19 vaccine trials (40%), followed by Immune Mediators (30%). The mRNA-based vaccine platform being used in some vaccines is a novel one, not used in any currently approved vaccines.

COVID-19 Trial Progress Tracker Shows 8 Trials Reporting Outcomes

WCG continues to track the progress of global interventional industry-sponsored COVID-19 trials that have been initiated so far this year – now numbering 412. Of those, 24 have been reported as complete, with five completing in the past three weeks since we last reported this data. To date, four studies have reported meeting their primary endpoint, with another four reporting they did not meet their endpoint. Notably, 127 studies are still planned for initiation in 2020, so this data will continue to reflect additional activity.

Still Signs of Uncertainty in 2020 Planned Trial Activity

According to industry-reported data tracking planned study starts and actual study starts so far this year (including COVID-19 and non-COVID-19 trials), WCG is tracking more than 1,800 studies that were originally planned to initiate by August and are still showing a status of planned and yet-to-be initiated as of September. Though overall 2020 study start volumes are down versus 2019, more than 4,400 trials were initiated from January through August. We’ll continue to track this data in Q4 and beyond, as sponsors navigate uncertainty and update trial status and plans accordingly.


Insights from September 4

Antiviral and Antibody-Based Products Lead COVID-19 Trial Volume Directed Against Virus

About a quarter of the industry-sponsored clinical trials for COVID-19 being conducted or planned in the U.S. as of Sept. 1 are studying agents in which the mechanism of action is primarily directed against the virus. Most of these agents are direct-acting antiviral therapies (50%), and antibody-based therapies (38%).

Serious Adverse Reaction Reporting Shows Uptick

WCG identified a drop in the number of serious adverse reaction reports distributed between February and April by the pharmaceutical companies and CROs using WCG SafetyPortal. The timing of the drop corresponds with the pausing of studies and the slowdown in patient visits associated with the first phase of the COVID-19 lockdowns. Between April and August, however, serious adverse reaction report distribution has returned to pre-COVID levels, consistent with the restarting of research studies in many centers.

Virus and Antibody Detection Remain Primary Focus for Diagnostic Trials

Of the industry-sponsored COVID-19 diagnostic device studies being conducted in the U.S. as of Sept. 1, 56% are looking at detection of the SARS-CoV-2 virus through genetic material or antigens, while 35% are looking for evidence of infection through antibodies generated by the person infected. A smaller number of products are being studied to detect specific COVID-19 signs and symptoms, such as ultrasound tools that can detect patterns of lung fluid abnormalities for rapid clinical diagnoses.


Insights from August 28

Change in Research (CIR) Submissions Driven by COVID-19 Continue to Trend Down from April

The number of Changes in Research (CIR) submissions related to COVID-19 peaked in April, at 58% of total CIRs, data from WCG’s Knowledge Base™ show. CIRs were driven by shifts to telemedicine and the shipment of drugs directly to study participants, among other factors. COVID-19-related CIRs continued to decline through July, representing just 13% of July CIRs.

Emerging Bio and Partnerships Dominating Industry-Sponsored COVID-19 Trials

Of the 381 industry-sponsored, global interventional COVID-19 trials, 88% are led by emerging and small pharmaceutical companies. Some of the notable new key players include BioNTech SE (Germany); CanSino Biologics and Sinovac Biotech (China); Ridgeback Biotherapeutics and Moderna (U.S.); and AbCellera (Canada).

Additionally, we are seeing a trend in partnerships, indicating the willingness of life sciences companies to collaborate on COVID-19 efforts for efficiency and speed. Noteworthy partnerships include:

  • Merck and Ridgeback Therapeutics
  • Regeneron and Sanofi
  • Roche and Gilead
  • Incyte and Novartis
  • Eli Lilly and Abcellera

2020 Planned U.S. Non-COVID-19 Trials Delayed an Average of 4.75 Months

Of the 295 non-COVID-19 industry-sponsored U.S. studies that have or had an original planned start date in 2020, 43% initiated at least one delay to their timelines, with a mean delay of 4.75 months. In a positive sign of recovery, since March, 63% of non-COVID-19 industry-sponsored U.S. studies that once reported being suspended have since restarted or completed.


Insights from August 21

More Than Half of Industry Sponsored COVID-19 Trials Located in North America

There are 455 ongoing industry-sponsored clinical trials for indications related to COVID-19. The chart shows the number of trials in each global region; if a trial has clinical sites in multiple regions, it is counted in each one. Due to the global nature of the pandemic, multi-regional studies are common and important in developing COVID-19 therapies.

72% of Planned U.S. COVID-19 Trials Have Delayed Start Dates

There are 43 industry-sponsored clinical trials for COVID-19 currently being planned in the U.S. Of the total, 31 have announced at least one delay to the originally planned study start date, with a mean delay of 1.8 months. That may reflect the aggressive goals of initial study timelines, as sponsors and researchers hope to move studies forward quickly and then have to adjust as start-up goals encounter real-life challenges.

Treatment Trials Show Highest Traffic in COVID-19 Trial Listings

Of the top 100 COVID-19 clinical trial listings attracting the most views on WCG CenterWatch iConnect, 53% are treatment related and 22% are vaccine trials, with the other 25% consisting of observational and diagnostic studies.

Despite making up just 22% of the trial listings, COVID-19 vaccine trials accounted for 35% of the views, indicating strong public engagement and interest in vaccine trial activity.


Insights from August 14

COVID-19 Trial Progress Tracker Shows 6 Trials Reaching Endpoints

WCG is tracking the progress of the 359 global interventional industry-sponsored COVID-19 trials that have been initiated so far this year. So far, of 19 that have been completed, four reported that they’ve met their primary endpoint, while two did not meet their endpoint. With a significant volume of trials still in motion, we’ll continue to track their progress and outcomes.

Contracting Turnaround Times Show Slight Improvement; COVID-19 Trials Still Fastest

Though contracting turnaround times are still longer than standard timelines in the U.S. (turnaround time up 13%) and EMEA (turnaround time up 10%), WCG is tracking a slight decrease in delays in both the U.S. and EMEA during May and July, with turnaround times down 2% to 3% versus March and April.

However, WCG data indicate that contracting for COVID-19 trials is moving much more rapidly, with ~57% shorter average turnaround times for COVID-19 specific trials as compared to all other trials.

COVID-19 Trial Locations Versus Virus Spread

This week’s data show that states with the fastest-growing number of cases in the past three weeks are currently under-represented in ongoing trial activity. Meanwhile, COVID-19 case counts are trending downwards in four of the top five states with the highest number of active trials. As sponsors consider new trial starts, the pace of the virus moving across states will be an ongoing factor and will force sponsors to be agile in site selection.


Insights from August 7

Sites Flag Trial Participant Buy-In as Top Concern in Restarting

Increasing participant buy-in to trials post-pandemic is an issue of major concern to most sites responding to a recent WCG CenterWatch survey. Respondents anticipated that their biggest challenge would be attracting new participants and getting current participants back into trials, placing the issue above compensating for lack of resources and adjusting for missing trial data. Current trial participants and future trial participants will require additional communication and reinforcements from the site that safety precautions are in place to protect them from COVID-19.

Traffic to Clinical Trials Listings Reflects Increased Interest in COVID-19

According to data from WCG CenterWatch iConnect, COVID-19 trial listings became the top-trafficked listings as of April. This surge in traffic coincided with decreased traffic to other condition listings. Since April, WCG CenterWatch iConnect has seen a continual increase in the percentage of traffic related to COVID-19, with COVID-19 trial listings representing 15.1% of total visits in the last 6 months, and rising to 28% of listing traffic as of June/July (vs oncology next at ~5%). Interestingly, overall traffic to trial listings increased 11% between April and July, indicating greater public interest in trial participation across the board.

View COVID-19 Trial Listings


Insights from July 31

Most Agents in Clinical Trials for COVID-19 are Intended to Moderate Immune Response

More than two-thirds of the clinical trials initiated for COVID-19 are testing agents designed to mitigate its clinical effects, while 25% are testing antivirals and 7% are testing vaccines.

Of the agents that may mitigate clinical impact, most are mediators of the immune system. This group includes general immune mediators and cytokine blocking agents, stem cells and nitric oxide-based therapies that describe their intended mechanism of action as improving immune function and combatting the cytokine cascade associated with the severe pulmonary effects of the virus.

Surge in New Investigators Conducting COVID-19 Research

From January to June 2020 there has been a 25% increase in new infectious disease investigators over all of 2019, reflecting a historic trend of physicians participating in clinical research for the first time during health crises. That trend is a reflection of new investigators wanting to help solve the ongoing crisis and the rapid increase in research opportunities from sponsors or other organizations.


Insights from July 24

61% of Sites Plan to Continue Using Remote Resources

Almost two-thirds (61%) of sites surveyed said they plan to continue using remote coordinators, after the COVID-19 pandemic. Pre-pandemic, only 15% used remote coordinators, rising to 40% as quarantine conditions kept staff from working onsite. Remote coordinators support on-site staff by handling data entry, patient follow up and recruiting efforts.

80% of Active Interventional COVID-19 Trials in U.S. Expected to Complete in Next Six Months

As active U.S. industry-sponsored interventional COVID-19 trials continue to progress, we see a marked difference in planned trial durations, which maps to the relevant goals and endpoints of vaccine studies compared to treatment studies. As of early July, 83% of vaccine studies are expected to take five months or longer to complete, while 62% of treatment studies are expected to complete within four months.

Accelerated Pace of COVID-19 Trials Continues

The majority of active industry-sponsored, interventional COVID-19 phase II and III trials initiated in 2020 are scheduled to conclude within two months. These short study timelines reflect the realities of drug development for acute illnesses: study drug administration is brief, endpoint assessment occurs quickly, sites are opened to enrollment quickly, and the rate of participant enrollment becomes the major driver of study durations.


Insights from July 17

Healthy Volunteer Clinical Studies Show Early Signs of Recovery

As expected, the conduct of healthy volunteer clinical studies was significantly impacted by the COVID-19 pandemic. In this assessment of global, currently active clinical studies, we can see that the number of study starts in the second quarter of 2020 began to recover.

COVID-19 Study Start and Completion Data Show Rapid Global Response

In this analysis of global clinical studies for COVID-19 and COVID-19-related conditions, we see the current status (as of July 14) of studies that started in each month of 2020. The remarkable number of new study starts, including 741 in April 2020, reflects the rapid response of the global scientific community to quickly design and initiate studies to investigate both preventive and therapeutic measures for COVID-19.

Spike in Change in Research Submissions Driven by COVID-19

The number of Changes in Research related to COVID-19 peaked in April, at 58% of total CIRs, data from WCG’s Knowledge Base show. The CIRs were driven by factors including shifts to telemedicine and the shipment of drugs directly to study participants.


Insights from July 10

296 Industry-Sponsored U.S. COVID-19 Trials In Process as of June 30

The number of industry-sponsored COVID-19 trials running in the U.S. increased 26% during the last two weeks of June, reflecting the speed at which the industry is pursuing diagnosis, treatment, and prevention of the disease. We’re keeping an eye on total volume, as well as trial types, as we continue to monitor industry efforts to mitigate the pandemic.

57% of Trials Disrupted During April Peak Have Now Recovered

As expected, there was a drastic increase in the number of industry-sponsored, non-COVID-19 trials disrupted in the first half of 2020 vs. the first half of 2019. Although disrupted trials account for a small fraction of the approximately 15,000 active trials in 2020, the seven-fold increase in disruptions versus 2019 represents a significant volume of trials impacted by COVID-19. 57% of the trials disrupted at the peak of the pandemic in April have since recovered, meaning they are either currently active or completed.

Clinical Trial Sites’ Adoption of Telemedicine Shifting Dramatically

A recent survey of clinical trial sites revealed that the adoption of telemedicine by U.S. sites more than doubled during COVID-19, with 73% of sites now indicating they plan to use telemedicine going forward.

In the survey, 72% of sites indicated that prior to the COVID-19 pandemic, they “rarely” or “never” use virtual visits for clinical trial participants. During COVID-19, however, 64% of sites reported using telemedicine “sometimes,” “often” or “always.”


Insights from June 26

Trial Starts Lag 2019 Pace, But June Shows Signs of Rebound

From January to May 2020, monthly non-COVID-19 trial starts averaged only 71% of last year’s pace, with the biggest drop unsurprisingly occurring in April and May. During those two months, starts dropped to half of last year’s starts in the same time frame.

However, if June continues at the current pace, it will likely meet or exceed June 2019 starts. That represents not only the highest percentage gain since the COVID-19 crisis, but also the nearest to 2019 levels so far this year.

Oncology, CNS Lead Non-COVID 19 Trial Starts

Approximately 35% of non-COVID-19 industry sponsored trials planned and started in the US after May 1 are in oncology. The hastened recovery in certain therapeutic areas comes as sites and sponsors seek to address patients in need of critical care.

June Welcomes Dramatic Drop in Site Start Uncertainty

This week, 75% of sites indicated readiness to restart screening within the next four weeks – an appreciable jump since we began tracking in April. Meanwhile, only 4% are still uncertain about their timing for restarting – the lowest percentage since our surveys began, and a drop of 18 percentage points since June 9.

Enrollment Recovery Hits Highest Point Since March – With 37% of Sites Surveyed Now Open to Enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during the pandemic. 37% of sites responding are now open to enrollment of new participants, up 7 percentage points from last week, and our largest percentage increase since tracking began in March.


Insights from June 19

Immune Mediators Continue to Lead COVID-19 Trial Volume, Diagnostic Devices Take 2nd Place

Total trial activity is dominated by interventional trials in the U.S. (88%), but we’re keeping an eye on growing demand for observational trials, which could have an impact on already burdened sites in hard-hit locations.

Among interventional trials, we’re tracking COVID-19 trials by product type. Since March 30, immune mediators have consistently represented 35% of total trial activity. But in the past two months, diagnostic device trials have overtaken antivirals as the second most-studied product type (20%). Interestingly, stem cell studies represent 7% of interventional trials.

Are COVID-19 Trials Keeping Pace with the Virus’s Spread?

This week’s data show that states with the fastest-growing number of cases in the past three weeks are currently under-represented in ongoing trial activity. Meanwhile, COVID-19 case counts are trending downwards in three of the top five states with the highest number of active trials. As sponsors consider new trial starts, the pace of the virus across states will be an ongoing factor and will force sponsors to be agile in site selection.

Enrollment Recovery Continues, with 30% of Sites Now Open to Enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during the pandemic. 30% of sites are now open to enrollment of new participants, up two percentage points from last week.


Insights from June 12

The backlog of new study starts continues to grow significantly

Although overall industry-sponsored study starts have been declining, the industry is showing substantial signs of being ready for restart.

Enrollment recovery continues, with 28% of sites now open to enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total non-COVID-19 trial enrollment is being affected during this pandemic. 28% of sites are now open to enrollment of new participants, up three percentage points from last week.

Optimism grows, as the number of sites that anticipate restarting screening in next two weeks doubles from previous week

Of sites surveyed, this past week showed a jump in optimism among sites that have not yet restarted screening. This week, 45% of sites indicated readiness to restart screening within the next two weeks – the highest percentage since tracking began in April. Meanwhile, 22% are still uncertain about timing for restarting, which is the lowest percentage since our surveys began.


Insights from June 5

Enrollment recovery continues, with 25% of sites now open to enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is recovering. 25% of sites are now reopen to enrollment of new participants. Of the investigators who are restarting enrollment, 46% are reporting only being open to restarting enrollment for ongoing trials at their site.

Healthy volunteer study starts dropped 73% when comparing Q1 2020 to Q1 2019

Healthy volunteer study starts have been impacted more than almost any other type of research in 2020, down 73% from Q1 2020 to Q1 2019. We expect this number to be significantly lower – with a potential decrease of close to 90% – when we ultimately compare Q2 2020 to Q2 2019.

43% of sites not yet open to enrollment plan on restarting enrollment within two weeks

Across the more than 1,400 sites surveyed, more than 60% of those still closed to enrollment expect to restart enrollment in June. And only 23% of sites are reporting that they still do not have a target date for reopening clinical trial enrollment at their site.

98 COVID-19 trials have been completed in four months, with an average duration of 30.25 days

Of the 1,416 studies started from February to May, 98 have already been completed. Of that number, 68 studies started in April and May are already enrolled and completed.

That said, we are seeing signs that enrollment is starting to slow on COVID-19 treatment studies. Where six weeks ago studies were regularly enrolling upwards of 20 patient per site, they are now commonly enrolling 3 to 5 patients per site. That number will continue to change due to the local incidence rate.


Insights from May 29

Active COVID-19 Trial Starts Hit 1,450 as 60% of Countries See an Increase in Pace of New Cases

More than 1,450 COVID-19 trials have been started in 2020, as the global number of COVID-19 cases reported tops 5.5 million. Of the 139 countries being tracked, 60% have more new cases reported in the last 5 days than in the prior 6-10 days… and those are just for the countries reporting case counts.

Enrollment Recovery Continues, With 23% of Sites Now Open to Enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic. 23% of sites are now open to enrollment of new participants – another 2 percentage point increase in the past week.

Serious Adverse Event Reaction Reporting Continues to Drop

WCG has detected a 30% drop in both unexpected and expected serious adverse reaction reports between February and April among the pharmaceutical companies and CROs using WCG SafetyPortal. That indicates a slowdown in patient visits since the start of the COVID-19 lockdown. Reporting initially fell 23% from March to April, then an additional seven percentage points by the end of April.


Insights from May 22

New Enrollment Recovery Continues, With 21% of Sites Now Open to Enrollment

WCG is tracking more than 1,400 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic. The four countries showing the largest amount of clinical trial restart activity in the past week are the U.S., Israel, Poland and Ukraine.

21% of sites are now open to enrollment of new participants, an increase of 10 percentage points in the last three weeks. We anticipate this trend to continue as countries reopen.

Global Investigator Restarts Focused on Ongoing Trials

Investigator restart comes in two forms – being open to enrollment of ongoing studies, and being open to enrollment of both ongoing and new trials. Very early data show that of the global sites that are restarting enrollment activity, 37% are open only to restarting ongoing trials, while 57% are open to enrollment of ongoing and new trials. 6% of sites are only open to new trials at this time.

That means that more than a third of investigators are still not willing to take on new trials that have been waiting to start since the COVID-19 outbreak. We will have more information on this next week.

Investigators Starting Trials in the U.S. Down Almost 50% in the Last 30 Day

New investigators study starts are down an average of 45.6% across the U.S., based on a comparison of investigator study starts from January 15 to February 15, versus starts in last 30 days.


Insights from May 15

Industry-Sponsored COVID Trial Placements Surge in the US

There are now more than 100 industry-sponsored and 250 total (industry and non-industry) COVID-19 trials running in the U.S. The state of New York alone has more than 60 industry-sponsored ongoing COVID-19 trials.

New Enrollment Recovery Continues, With 15% of Sites Now Open to Enrollment

WCG is tracking more than 1,250 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic. The total number of sites reporting that they’re open to enrollment increased this past week – from 13% to 15%.

Continued Signs of Restart Readiness

There continues to be more enthusiasm for restarting ongoing studies, even at sites that still have studies on hold. Last week, 4% of sites queried reported being ready to restart within the next two weeks, and 51% in the next two to four weeks. That has now shifted to 35% stating that they will be ready to restart in the next two weeks and 44% being ready in the next two to four weeks.


Insights from May 8

The Impact of COVID-19 on Enrollment at Study Sites

WCG is tracking more than 1,250 sites in 29 countries to understand how quickly total trial enrollment is being affected during this pandemic.

For the first time in eight weeks, the total number of sites open to enrollment increased, up to 13%.

Demand for New Study Starts Continues to Increase Over Time, as Enrollment Holds Persist

Although overall industry-sponsored study starts have been declining, the industry is showing substantial signs of being ready for restart. WCG anticipates that will result in a number of studies opening at the same time, with the largest number of planned restarts in the oncology space.

Early Signs of Sites Being Ready for Restart

Sites surveyed May 2 were more than twice as likely to consider reopening enrollment in the next two to four weeks than when surveyed on April 25. The critical question becomes how sites will best support new trial starts and ongoing study restarts.

COVID-19 Trials Continue the Shift to Immune Mediators

The number of US-based COVID-19 trial starts has tripled since March 30. During that time, the percentage share for immune mediators trials has grown from 21% to 35%.

 


Insights from May 1

The Impact of COVID-19 on Enrollment at Study Sites

WCG is tracking more than 1,250 sites in 29 countries to understand how quickly total trial enrollment is being affected during the COVID-19 pandemic.

In the last week, the total number of sites open to enrollment did not decrease, remaining at 11%.

Many Sites Unable to Foresee Timeline for Reopening Enrollment

When asked, 35% of sites said they could not estimate when they will reopen, and only 13% of sites said they could see themselves opening to enrollment by mid-May.

Contracting Times Slowing, Except for COVID-19 Trials

The COVID-19 pandemic has slowed down the overall turnaround time for clinical trial contracting between sites and sponsors. In the last six weeks alone, overall contract turnaround time across all trials has increased 12% according to EMEA data, while US clinical trial contracting time has increased more than 15%.

That said, there is one clear exception – on average, contracts for COVID-19 trials are being executed in less than 7 days.

COVID-19 Trials Growing Quickly, Shifting to Immune Mediators

The number of active COVID-19 industry-sponsored trials has more than doubled in the last four weeks to more than 150 trials globally.

Of note, four weeks ago sponsors were focused on antiviral trials, but there has been a significant shift, with the majority of industry-sponsored interventional trials now focused on immune mediators.


Insights from April 24

The Impact of COVID-19 on Enrollment at Study Sites

WCG is tracking more than 1,250 sites in 29 countries to understand how quickly enrollment is being affected.

As of this week, only 11% of tracked sites are currently open to clinical trial enrollment. That represents a percentage point decrease from last week and half the open sites from three weeks ago.

Site Enrollment Declines Driven by Sponsors

Of the 1,250 sites that WCG is tracking, 62% have a hold on enrollment due to sponsor-enforced, study-wide orders.

Serious Adverse Reaction Reporting Down

WCG has detected a 23% decline in both unexpected and expected serious adverse reaction reports in March and April across the largest pharma and CROs using WCG SafetyPortal. That indicates a slowdown in patient visits since the start of the COVID-19 lockdown.

Only Four Countries Operating Close to Pre-COVID-19 Levels

Clinical trial activity continues to decrease globally, with only four countries projected to exceed pre-COVID-19 patient assessment volume during April.

That is down from March, when eight countries showed the same or more patient assessments for ongoing trials than in February.


Insights from April 17

Current State of COVID-19 Trials in the US

The current US trials are operating on a fast enrollment pace, with 30 percent expected to be fully enrolled within 3 months.

More than 6,500 participants are currently needed to fill open slots in the 56 active COVID-19 industry-sponsored trials in the US. In the last six weeks, the US added two new trials, up from 54.

Look to New Locations for COVID-19 Study Starts

While investigators in New York are turning away study opportunities because of oversaturation and a lack of staff to support a clinical trial, sponsors should consider opening trials instead in New Jersey, Massachusetts, Pennsylvania and Illinois. Although oversaturation is not yet an issue in those states, sponsors may still have to augment site staff.

The Impact of COVID-19 on All Study Sites

In the last week, only 12 percent of the 1,250 non-COVID-19 sites WCG is tracking in 29 countries reported being open to enrollment, a decrease of 2 percentage points from the prior week.


Insights from April 10

The Impact of COVID-19 on Study Sites

We’re tracking over 1,000 sites in 29 countries to understand how quickly enrollment is being affected. According to WCG Data, this week, only 14% of sites are reporting being open to enrollment – an 8% decrease just since last week.

Trials on Hold

100 non-COVID-19 trials have been placed on official hold within the last month, as compared to 12 trials put on hold the month prior to start of the pandemic impact.

COVID-19 Trials

In the US there are now more than 60 ongoing COVID-19 trials with over 150 sites open and enrolling.


Insights from April 2

The Impact of COVID-19 on Study Sites

According to WCG Data:

88% of sites reported an impact on study status due to COVID-19

79% of sites noted that they’re limiting enrollment at this time

COVID-19 Study Start-Ups

Since January 1, there have been more than 400 COVID-19-focused studies started globally.

Vaccine vs. Non-Vaccine Trials

Fewer than 5% of active trials are focused on vaccines. We expect the number of COVID-19 vaccine trials to increase over the next 4 months.

Gain actionable insights to advance current and planned studies with the WCG Knowledge Base™

Need help interpreting critical data to navigate the impact of COVID-19 on trials and sites? Interested to see how investigators in current or planned studies match up against historic performance of all available investigators in critical therapeutic areas?

Complete the form to schedule a consultation with WCG. We leverage insights and benchmark data from the WCG Knowledge Base™ to determine the best practices driving trial performance during this unprecedented time.