With half of the drugs in Phase III programs never reaching the market, adaptive trial designs can help sponsors pinpoint Phase III dosages and increase clinical trial success, Olga Marchenko, director of biostatistics at i3 Statprobe and head of the Adaptive Design Consulting Group, said at a recent FDAnews webinar. When patients respond quickly to drugs and recruitment is slow, adaptive designs can be particularly effective, she added.
Clinical Trials Advisor