Clinical trials, especially the randomized clinical trial, have been and will remain the gold standard for the evaluation of new interventions, be they pharmaceutical, biologic, medical device, procedures or behavioral modifications. Despite more than 5 decades of experience, there are challenges in their design, conduct, monitoring and analyses. Some of these challenges remain and some are emerging, in part due to the progress in genomics and proteomics. These issues may be statistical, logistical or a combination. A discussion of some of these will be presented with points of view shared. These issues include follow-up of subjects who withdraw from intervention, the proposed use of recent adaptive designs, implementing non-inferiority designs, reliance on surrogate markers and gene transfer studies.
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