WCG has been getting a lot of questions about clinical trial conduct in the age of COVID-19. And, in response, they held a webcast to provide information and field questions. On the same day, the FDA released its guidanceCoronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials, and aligned very much with what the WCG panel members had to say.

The webcast opened with Arthur L. Caplan, PhD, Professor of Bioethics and Founding Director, Division of Medical Ethics, NYU Langone Medical Center, who provided the background on the moral considerations around conducting clinical research at this time. This primarily is reflected by decisions to suspend clinical research in hospitals and academic health systems, such as University of Pennsylvania, Johns Hopkins, and Harvard.¹ And as Caplan noted, PIs and clinical study nurses are being pulled to ICU or to staff shifts during the crisis. 

The WCG presenters-David Borasky, MPH, CIP, Vice President, IRB Compliance; Suzanne Caruso, Vice President, Clinical Solutions, and Mike Cioffi, Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG MedAvante-ProPhase-said what they are hearing from investigators and staff reflects what Caplan noted: clinical research departments being closed to ensure room for COVID patients; reallocation of staff supporting clinical trials to primary treatment and care; staff can’t take the time to field calls from clinical trial participants; increased administrative burden for rescheduling and offering new options; and non-essential staff being asked to work from home.  

To help investigators and site staff, they emphasize communication and documentation. Caruso suggested the key words to remember during the crisis are flexibility, try new things (i.e., webinars for clinical trial teams), transparency, and communications. Differences of communication and needs should reflect the concerns of type of site, i.e., the large hospital and academic medical center vs. a rural area and smaller centers. 

On the IRB side, questions around what needs to be IRB-approved and what doesn’t were discussed by Borasky. What does? Changes in study procedures, or changes in provision of investigational product, such as direct shipment to the participant. What doesn’t need IRB approval? Changes to monitoring, i.e., from on-site to remote or centralized model. As Borasky noted, IRB’s don’t approve those even during a non-crisis, so any monitoring plan changes need not to go the IRB route. Most of all, the WCG team stressed that any changes to the trial or site conduct or participant status, needs to be documented.

There was a lot of information shared, and the webcast lasted for 1.5 hours-a bit over an hour for presentations and a robust 30-minute Q&A. To watch the on-demand version, go here.

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline

References

1. https://www.sciencemag.org/news/2020/03/updated-labs-go-quiet-researchers-brace-long-term-coronavirus-disruptions