COVID-19 Trial Insights from the WCG Knowledge Base™

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

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Insights from October 16

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

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

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

 

COVID-19 Trial Progress Tracker Shows 10 Trials Reporting Outcomes

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


Insights from October 9

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

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

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

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

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

Oncology Studies

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

CNS Studies

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

Cardiovascular Studies

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

Infectious Disease Studies

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


Insights from October 2

Treatment Trials Show Highest Traffic in COVID-19 Trial Listings

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

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

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

Immune Mediators Remain Primary Product Type for COVID-19 Trials

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


Insights from September 25

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

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

COVID-19 Trial Locations Steady; Virus on the Move

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

Total 2020 Trial Starts Lagging Prior Years

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


Insights from September 18

Downward Trend in New Principal Investigator Trial Participation

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

Total 2020 Trial Starts Lagging Prior Years

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

 

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

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


Insights from September 11

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

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

COVID-19 Trial Progress Tracker Shows 8 Trials Reporting Outcomes

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

Still Signs of Uncertainty in 2020 Planned Trial Activity

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


Insights from September 4

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

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

Serious Adverse Reaction Reporting Shows Uptick

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

Virus and Antibody Detection Remain Primary Focus for Diagnostic Trials

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


Insights from August 28

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

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

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

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

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

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

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

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


Insights from August 21

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

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

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

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

Treatment Trials Show Highest Traffic in COVID-19 Trial Listings

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

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


Insights from August 14

COVID-19 Trial Progress Tracker Shows 6 Trials Reaching Endpoints

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

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

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

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

COVID-19 Trial Locations Versus Virus Spread

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


Insights from August 7

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

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

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

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

View COVID-19 Trial Listings


Insights from July 31

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

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

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

Surge in New Investigators Conducting COVID-19 Research

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


Insights from July 24

61% of Sites Plan to Continue Using Remote Resources

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

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

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

Accelerated Pace of COVID-19 Trials Continues

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


Insights from July 17

Healthy Volunteer Clinical Studies Show Early Signs of Recovery

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

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

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

Spike in Change in Research Submissions Driven by COVID-19

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


Insights from July 10

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

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

57% of Trials Disrupted During April Peak Have Now Recovered

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

Clinical Trial Sites’ Adoption of Telemedicine Shifting Dramatically

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

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


Insights from June 26

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

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

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

Oncology, CNS Lead Non-COVID 19 Trial Starts

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

June Welcomes Dramatic Drop in Site Start Uncertainty

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

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

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


Insights from June 19

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

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

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

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

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

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

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


Insights from June 12

The backlog of new study starts continues to grow significantly

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

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

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

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

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


Insights from June 5

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

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

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

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

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

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

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

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

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


Insights from May 29

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

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

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

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

Serious Adverse Event Reaction Reporting Continues to Drop

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


Insights from May 22

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

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

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

Global Investigator Restarts Focused on Ongoing Trials

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

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

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

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


Insights from May 15

Industry-Sponsored COVID Trial Placements Surge in the US

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

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

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

Continued Signs of Restart Readiness

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


Insights from May 8

The Impact of COVID-19 on Enrollment at Study Sites

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

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

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

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

Early Signs of Sites Being Ready for Restart

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

COVID-19 Trials Continue the Shift to Immune Mediators

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

 


Insights from May 1

The Impact of COVID-19 on Enrollment at Study Sites

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

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

Many Sites Unable to Foresee Timeline for Reopening Enrollment

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

Contracting Times Slowing, Except for COVID-19 Trials

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

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

COVID-19 Trials Growing Quickly, Shifting to Immune Mediators

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

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


Insights from April 24

The Impact of COVID-19 on Enrollment at Study Sites

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

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

Site Enrollment Declines Driven by Sponsors

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

Serious Adverse Reaction Reporting Down

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

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

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

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


Insights from April 17

Current State of COVID-19 Trials in the US

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

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

Look to New Locations for COVID-19 Study Starts

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

The Impact of COVID-19 on All Study Sites

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


Insights from April 10

The Impact of COVID-19 on Study Sites

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

Trials on Hold

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

COVID-19 Trials

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


Insights from April 2

The Impact of COVID-19 on Study Sites

According to WCG Data:

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

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

COVID-19 Study Start-Ups

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

Vaccine vs. Non-Vaccine Trials

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

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

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

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