Vladimir Dragalin (Janssen), QiQi Deng (Boehringer-Ingelheim) and Scott Berry (Berry Consultants) were the presenters for a balanced view of the benefits and ongoing issues of concern related to adaptive designs to an audience of over 200.
Adaptive clinical trials use accruing data to make changes in the ongoing trial. Changes based on early information can increase efficiency, by limiting resources to likely failures and increasing them for promising interventions. Such changes are also likely to be beneficial from the patients’ perspective. Although adaptive trials have been part of drug development for about 30 years, there is still some confusion over the best ways to utilize them.
Vladimir Dragalin's presentation was entitled "Thoughts on ICH E20 EWG on Adaptive Clinical Trials." Vladimir reviewed his very recent work with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the E20 proposal that this group is currently working on that focuses on adaptive clinical trials. His insights regarding the bringing together of both regulatory authorities and pharmaceutical industry representatives to discuss the scientific and technical aspects of adaptive clinical trials were extremely informative.
QiQi Deng, (Boehringer-Ingelheim) was the second speaker. Her talk focused on the particular nuances of the "Two-stage adaptive design in dose-ranging studies and the alternatives." While combining a proof of concept study with the dose-ranging study into one trial has its advantages, the risks are apparent. QiQi instead outlined the details of a two-stage stepwise design and discussed the advantages of this innovative alternative.
Scott Berry was the final speaker of the session. His talk was entitled "Innovating the Clinical Trial: Adaptive and Platform." He began by providing general comments and insights regarding adaptive trials and expertly followed this up by walking through a number of innovative examples that highlighted new approaches including seamless, adaptive enrichment design, adaptive platform trial, and others.
As with all of the NISS/Merck Meet-Up events, Dan Holder (Merck) served as general organizer and was moderator of the session.
Recording of the Session
Slides used by the Speakers
Vladimir Dragalin, (Janssen)