Tracking the International Effort to Keep Clinical Trials for Non-COVID-19 Treatments Moving

Faegre Drinker Biddle & Reath LLP

Faegre Drinker Biddle & Reath LLP

Recently, public attention has been captured by the progress of medical treatments and vaccines against COVID-19, which are currently going through clinical trials (categorized into phases 1, 2 and 3).1

Regulatory agencies in the U.S. and other countries tasked with reviewing and approving these and other medical products have been issuing guidelines and Q&A documents to facilitate their expedited development.2

At the same time, medical products for conditions other than COVID-19 have faced significant headwinds with subject recruitment and retainment and the overall conduct of clinical trials.3

Scientists across government agencies, academia and industry are therefore exploring new ways to continue this much-needed work. Possible adjustments range from behavioral and physical modifications, for example, as recommended by the following regulatory agencies:

Further, as explained in the following publications, others have proposed new statistical solutions:

For additional information on these topics or for help with related regulatory issues, please contact Dr. Lana Lyapustina at Faegre Drinker.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Faegre Drinker Biddle & Reath LLP | Attorney Advertising

Written by:

Faegre Drinker Biddle & Reath LLP

Faegre Drinker Biddle & Reath LLP on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide

This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.