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 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.

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