ISCTM Meeting Discusses Clinical And Regulatory Aspects Of Using Adaptive Designs In Clinical Trials For Central Nervous System Drug Approvals

Main Category: Neurology / Neuroscience
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Oct 2009 - 22:00 PDT

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A one day session on the use of adaptive designs for more efficient conduct of clinical trials for CNS indications chaired by Andrew C. Leon, PhD, Cornell University, and Donald Berry, PhD, M. D. Anderson, Department of Biostatistics, was held 5 October 2009, at the International Society for CNS Clinical Trials and Methodology (ISCTM) Autumn Meeting in San Diego, CA.

This session included an introduction to concepts of adaptation and how trials with pre-specified design modification might expedite the regulatory approval process for specific indications by V Dragalin, PhD, Wyeth Research Department of Biostatistics. Target areas for adaptation that were considered include modification of inclusion/exclusion criteria, dosing, sample size, number of cells, and treatment duration. HM Hung and SJ Wang, both from the US FDA and A Koch, from Germany's BfArM, provided regulatory insights into the use of adaptive designs by reviewing the FDA's Draft Guidance for Adaptive Designs and the Reflection Paper on adaptive designs recently developed by the European Medicines Agency (EMEA). Y Ando from Japan's PMDA discussed issues from applications that have been reviewed by the PMDA. The session concluded with CNS case studies that highlighted logistic and pragmatic challenges to the application of adaptive design. Dr. Leon stated, "This session provides sponsors an overview of the costs and benefits of adaptive designs so that they can be more effectively incorporated into the designs of clinical trials for CNS indications."

Source
ISCTM

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