Prior to the approval of new drugs, substantial evidence of efficacy is required and safety brought through clinical trials. A massive decline in success rates in Phase II/III of clinical trials has resulted in only 1 in 10 drugs successfully passing through these trials in the US.
With increasing pressure to bring drugs quickly into the market and reduce the cost of drug development, the paradigms of drug dosage studies in phase II trials and the overall adaptive framework of clinical trials are being increasingly challenged. Thus, strategies such as “Seamless Adaptive Designs” and “Group –Sequential Adaptive Designs” are particular areas that have received a great deal of attention in helping to improve the efficiency of drug development.
This conference will review the drug development process and provide a detailed discussion of how adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial. It is designed for those looking to network and gain the latest knowledge from the academics, industry leaders and regulators.
http://www.smi-online.co.uk/pharmaceuticals/uk/conference/adaptive-designs
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