Clinical Trial Insights from the WCG Knowledge Base™

Sites Increasingly Taking on Full-Time Research

More sites are taking on research as a full-time activity, according to the WCG CenterWatch 2021 Global Site Relationship Benchmark Survey. The percentage of sites that said they conduct research full-time has increased by 24 percentage points since 2017, the survey shows.

Sponsors Score Highest on Five Performance Attributes, but Scores Declining

Sites responding to the WCG CenterWatch 2021 Global Site Relationship Benchmark Survey gave their sponsors high ratings on the quality of their staff, organization and communication. But a look at results from previous years’ surveys show sponsors’ scores on some of the same attributes have dipped since 2019.

Survey Results Show Protocols Issues Increasingly Important to Sites

An early look at responses to the WCG CenterWatch 2021 Global Site Relationship Survey show a shift in which sponsor attributes sites feel are most important. This year, handling of protocols is far more important to sites, with two protocol-related attributes moving into the top 10 list out of 40 attributes. The two new attributes in the top 10 – “designs patient-friendly protocols” and “has protocols … aligned with clinical practice realities” – bumped out “works effectively with CROs” and “sets realistic project timelines,” which received 57% and 60% of sites’ votes in 2019. This year, those two attributes were ranked 13th and 14th, respectively.

Early and Mid-Phase Trials Lead Industry Pipeline for Osteoarthritis

Following up on World Arthritis Day and last week’s insight, further analysis of the osteoarthritis clinical trials landscape reveals that early and mid-phase trials lead the industry sponsored pipeline of active trials with more than half (56%) being Phase II trials. Continuing to deliver effective treatments to patients with OA remains critical. The economic burden associated with OA has more than doubled in the past decade, eclipsing $135 billion annually, with an estimated 1 million knee and hip replacements occurring each year due to OA.

To further frame this global perspective, most PIs conducting these active trials are located in the U.S. and China, with PIs in each country leading an average of more than four ongoing trials.

The Osteoarthritis Health Crisis And Clinical Trials

The Centers for Disease Control (CDC) estimates that more than 54 million adults in the U.S. are inflicted by arthritis, with osteoarthritis (OA) as the most common form affecting 32.5 million adults. Globally, OA is the third most rapidly rising disability behind diabetes and dementia. Many OA patients further struggle to self-manage other chronic conditions such as diabetes, hypertension, and related symptoms of depression.

OA clinical trials are confronted with several study design challenges, including endpoint and assessment selection, managing placebo effects, and training of patients to attain the most accurate reporting of symptoms due to the variability in pain experienced and the cyclical nature of the disease. With an expected increase in the prevalence of OA and most active OA trials in Phase I or Phase II, the pressure to expand effective treatment options mounts.

As trials advance, having well-established EAC and DMC processes support close monitoring of ongoing trial data, with clear safety alert guidelines and stopping rules to ensure that patient safety is being properly monitored are critical.

PI Participation A Driving Force Behind COVID-19 Trial Successes

In 2020 and 2021, when the clinical trials industry was in the midst of an unprecedented need for delivery and execution, more than 5,800 principal investigators (PIs) in the U.S. answered the call to conduct clinical trials to provide patients with access to potential antiviral agents and vaccines and to treat post-COVID symptoms.

These PIs ranged across a variety of specialties with internal medicine, infectious disease, critical care, and pulmonary physicians leading the charge. A notable 30% of the PIs managed to initiate multiple COVID-19 trials to combat the pandemic and nearly a third had conducted at least 10 clinical trials in the past. Commendably, a remarkable 23% of the PIs were conducting their first clinical trial when they were needed most.

Cardiovascular Trials and Related Disease Trends

Our WCG Knowledge Base™ insights previously revealed that the U.S. experienced an 8% increase in industry-sponsored trial starts from 2019 to 2020. Interestingly, cardiovascular trials were one of only three therapeutic areas to increase in trial volume during an unpredictable 2020.

One trend that has remained predictable over the past two decades, however, is that heart disease, the leading cause of death in both men and women globally and in the U.S., continues to grow at a rate that outpaces all other diseases. The World Health Organization (WHO) estimates that since 2000, the number of deaths attributed to ischemic heart disease has risen by more than 2 million to 8.9 million. The Centers for Disease Control and Prevention indicate that one person dies in the U.S. every 36 seconds from cardiovascular disease and that heart disease is responsible for one in every four deaths each year.

Beyond the increase in cardiovascular disease, diabetes has also exhibited a significant increase in global deaths with a jump of more than 70% since 2000 according to WHO, and the prevalence of diabetes doubles the likelihood that someone will suffer from heart disease or stroke.

We have explored the U.S. clinical research site landscape for sites treating patients in cardiovascular trials to provide perspective into which related diseases those sites are most frequently engaging in across on-going industry sponsored clinical trials.

Trial Starts Continue to Increase First Half of 2021

Previously in our WCG Knowledge Base™ insights we highlighted the resiliency and adaptability of the clinical trials industry to finish 2020 with an 8% increase in trial starts following a sluggish start to the year due to the impact of COVID-19.

One point of concern was the impending bottleneck that clinical trial sponsors and sites faced as 2021 began, after more than 800 planned trials had missed their start date the prior year. Data from Q1 and Q2 2021 demonstrated that sponsors are pushing trial starts forward at a tremendous pace with an increase of 44% from Q1 2020 to Q1 2021 and an increase of 52% from Q2 2020 to Q2 2021. These early 2021 totals also surpassed the number of trials initiated in each of the first two quarters in 2019, respectively.

In navigating this bottleneck sponsors and sites will continue to juggle the significant staff turnover exacerbated by the pandemic, existing enrollment challenges, and balancing their ongoing and planned trial portfolio.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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%.

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.

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.

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.

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.

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.

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.

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.

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%).

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.

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.

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.

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.

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.

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.

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.

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.

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.