Recently the ISCTM convened two working groups to provide comment on the FDA draft Guidances relative to two topics that we have been considering in our meetings: 1)Adaptive Design (2009 Autumn Conference -- Adaptive Design session) FDA Guidance Document UCM201790.pdf; 2) Non-inferiority trials (2009 5th Annual meeting -- Active Comparators session) FDA Guidance DocumentUCM202140.pdf
This was quite a time consuming effort and we wish to acknowledge the following members for their excellent work on drafting comments which were submitted by the ISCTM to the FDA:
Adaptive Design Working Group: Andrew C. Leon PhD (Chair), Brendon Binneman MBChB, MRCPsych, Vlad Dragalin PhD, Judith Dunn PdH, Douglas Feltner MD, Ilise Lombardo MD, Virginia Sutton PhD and Ibrahim Turkoz MS.
View Adaptive Design response.
Non-inferiority Trials Working Group: Andrew C. Leon PhD (Chair), Atul Mahableshwarkar MD, Joanne Severe MS, Murray Stein MD, MPH, FRCPC, and Jane Tiller. View Non-inferiority Trials response.