Considering the Realities of Restarting Trials Post-COVID-19

Suzanne Caruso, Vice President for Clinical Solutions, WCG

If it’s possible to take a “this too shall pass” attitude toward the current health crisis, one has to assume that many of the clinical trials having nothing to do with COVID-19 that were interrupted earlier in 2020 will eventually be put back on track by sponsors and sites. How to best manage doing so, including communicating to new and returning participants important changes made at study sites owing to the pandemic, was the focus of a recent WCG webinar in which several experts spoke to how the clinical research enterprise’s rapid response and flexibility under stressful conditions have been nothing short of amazing.

“Thinking [back to 2019 about] what we were planning for 2020 [in terms of] trials…I don’t think any of us really saw COVID-19 coming, and it has really changed the landscape of clinical trials,” said Suzanne Caruso, vice president for clinical solutions with WCG. According to a WCG analysis of global data, more than 950 active trials in COVID-19 therapies have been launched, and “that’s a lot of trials and a lot of patients in a very short time,” Caruso noted. “That speed in getting trials going is going to have a lasting impact on trials going forward.”

Not only is the speed at which data are coming in impressive, Caruso said it is meaningful toward how researchers are going to maintain this newfound rapidity in information gathering for future studies in all types of indications. “The majority of trials in COVID are going from having a final protocol to first patient first visit in four weeks,” she added. Pre-pandemic, this would likely have taken six months for most studies, “or if you were really efficient, you could get it down to three,” she said.

The agility with which clinical researchers are looking for COVID-19 treatments “is something I think will last well beyond our COVID experience…and in building trials” in the future, Caruso said. Adding that prior to January 2020, an average of only seven trials per month were likely to be put on hold for any reason in the research enterprise, but as of April 2020 the figure is 129, she foresees an oncoming “collision” of new trials that sponsors wish to start and old trials being restarted as pandemic conditions wane.

Further, a recent WCG survey of 1,250 sites around the world found 51% of respondents said they could be ready for new non-COVID trial enrollments in two to four weeks.

“All of us have been very focused at the site level…on what we’re doing trying to prepare ourselves…to be ready to go,” in terms of restarting enrollment for interrupted studies or finally starting studies that had been postponed, said Tom Wardle, CEO of CenExel Clinical Research. “Adapting to what’s happening in the world requires a very strong educational response to the study participants,” including demonstrating to them as they come into a trial how serious the site is about taking precautions to minimize the risk of infection onsite.

Edward A. Jones, MBA, president and CEO at Houston Methodist Research Institute, added that as his institution moves forward with new studies, the questions include “Are we going to have the staff we need? [The] staff that we have are fatigued—they’ve been through an awful lot in the last four to six weeks and we are going to ask more of them.” Beyond that, there are staff-related concerns regarding COVID-19 testing and surveillance, dependent care, social distancing, personal protective equipment, and cross functional resources, he said.

“As we headed into the crisis, we did not have an infectious disease [focus in our research],” Jones noted. “[Now], how do we balance our needs for [this] new line of inquiry that we desperately need to resolve with getting coordinators back to their original studies?” On top of which, participants may be coming back to trials sicker than they were originally, having avoided healthcare facilities during the crisis, he added.

Author: Gary Cramer