Chapter 10 – Are Your Clinical Trials Impacted by COVID-19?
Because I spend a lot of time thinking about the approval process for new medical products, I had already begun to consider the impact of travel and access restrictions on the conduct of clinical trials. Trial disruptions may include difficulties in following the protocol to enroll new patients, evaluate currently enrolled patients, and start/stop treatment phases. Trials may also experience data loss due to patient drop out as a result of the stay home orders or the impact of COVID-19 on vulnerable populations. The FDA released an immediately in effect guidance last week on the conduct of clinical trials of medical products during the COVID-19 pandemic. This guidance covers clinical trials for all products, and focuses on the approaches sponsors, investigators, and Institutional Review Boards should take to 1) protect the safety and welfare of patients, and 2) minimize the impact to the trial of the pandemic. The suggestions include implementing policy and procedures to manage possible disruptions to the study, fully documenting any disruptions that occur, working to maintain study data integrity, and other ways to overcome difficulties in meeting the procedures of the existing protocol, including protocol modifications and deviation documentation. We can also expect to see companies adjusting their current trials as they redirect resources towards the pandemic response. Moderna is a good example of this response, as they have paused enrollment in some infectious and rare disease trials as they work to continue their cancer trials and work on a COVID-19 vaccine (read this FierceBiotech article for more detail).
Reach out to me if you want to know more or discuss your medical product development challenges.
Text Copyright © 2020 Katrina Rogers
Share this post: