Global Harmonization of Standards for Adaptive Clinical Trial Designs

Recently, important initiatives, including evaluation of adaptive design clinical trials, have been undertaken by regulatory authorities and industry associations to promote innovation in global drug development to address the slowdown in development of new medicines. In the US, the Food and Drug Administration (FDA) created the Critical Path Initiative to focus on ameliorating problems in the current drug development and approval model. One opportunity identified in the Critical Path Initiative is more-efficient trial design. This has led to the investigation of adaptive design as a way to conduct clinical trials more effectively.