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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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.
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%).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 show a dramatic dip in trial starts this year, as compared to the rolling three year mean.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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%).
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.
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.
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.
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.”
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.
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.
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.
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.
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.
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.
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.
Although overall industry-sponsored study starts have been declining, the industry is showing substantial signs of being ready for restart.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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%.
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.
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%.
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.
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.
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%.
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%.
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.
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.
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.
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.
Of the 1,250 sites that WCG is tracking, 62% have a hold on enrollment due to sponsor-enforced, study-wide orders.
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.
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.
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.
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.
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.
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.
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.
In the US there are now more than 60 ongoing COVID-19 trials with over 150 sites open and enrolling.
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
Since January 1, there have been more than 400 COVID-19-focused studies started globally.
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.
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