Restarting Studies After COVID-19 Will Require Adaptations, Scrutiny of Study Site Capacities

Alison Lakin, associate vice chancellor for regulatory compliance at the University of Colorado, Denver, Anschutz Medical Campus, acknowledged that it might seem inconceivable at the height of a pandemic to “start thinking about ramping back up research.”

But she called this “the right time to be strategically thinking about how we efficiently, collaboratively and in a coordinated manner move forward” with clinical trials and ensure the safety of participants.

Heeding the call from governments and public health officials, much research on U.S. campuses has been shut down since the COVID-19 public health emergency was declared in March.[1] Universities and other institutions have scrambled to salvage what research they could, incorporating remote visits for clinical trial participants and, in some cases, allowing only studies related to COVID-19 to go ahead.

Lakin deemed the last two months “a challenging hiatus” and said more difficult times lie ahead, when clinical research is restarted. Nevertheless, “on a positive note…we have an opportunity…to collaborate together in a different way than we’ve done before. There are lessons that we can learn from this experience,” she said.

Already Laskin has gained insights, including that research might be changed forever in some respects—with innovations like e-consents becoming common—and she also suspects that Americans are likely to have much greater interest in supporting drug development and may themselves be more eager to participate in research.

This document is only available to subscribers. Please log in or purchase access.
 


Would you like to read this entire article?

If you already subscribe to this publication, just log in. If not, let us send you an email with a link that will allow you to read the entire article for free. Just complete the following form.

* required field