Clinical Trial Sites are Poised to Reopen, according to WCG Clinical

Throughout the pandemic, WCG has been tracking trial and site activity. Here is a summary from this week.

1. For the first time in 8 weeks, the number of sites open to study enrollment is increasing. WCG follows over 1,250 sites across 29 countries and the number of sites open to enrollment has increased from 11% to 13% (roughly 163 trial sites).

2. As of April 24th, 62% of sites said that enrollment holds were enforced by sponsors. Now that the industry is ready to restart, many studies will open at the same time (i.e., sponsors will lift enrollment holds for any ongoing studies, studies that were in planning will be initiated).

3. For the sites that are not yet open, 51% are considering reopening enrollment in the next 2-4 weeks.

CRIO interviewed several research sites and found that several are already ramping up research activities.

One site told CRIO, “we are ready for research to get back to normal.” The same site explained that they have a new study starting in the next couple days pending green-light, and that they are scheduled to start working on a new trial by a major sponsor.

Download: COVID-10 SOP Templates for Clinical Research Sites

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According to another site in Michigan, “We plan to return to full time work by early June, unless the Governor extends the stay-at-home mandate again. We are working on starting four trials, so as demand increases for appointments we will extend our hours.”

As sponsors resume studies and initiate new trials, it is critical that sites are prepared to conduct patient visits amidst the ongoing pandemic. Edward Jones of Houston Methodist Research says COVID will be with us for a while. As such, sites must continue to take necessary precautions to ensure patient safety and maintain the integrity of trial data.

Read more advice from industry experts on how to prepare your site for study restarts.

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