ISCTM Meeting Discusses Clinical and Regulatory Aspects of Using Adaptive Designs in Clinical Trials for Central Nervous System Drug Approvals

SAN DIEGO--(Business Wire)--
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adaptive designs by reviewing the FDA`s Draft Guidance for Adaptive Designs and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."

The ISCTM (www.isctm.org) was founded in 2004 to gather representatives of
academic and clinical specialties, the pharmaceutical industry, and regulatory
bodies to exchange ideas about important clinical and public-health challenges;
to examine the development of novel treatments for major psychiatric and
neuropsychiatric disorders; and to support advances in methods of evaluating
such treatments that are scientifically sound, ethical, and feasible. To achieve
this mission, ISCTM conducts two scientific meetings per year. The 6th Annual
Scientific Meeting, (including the National Mental Health Research-to-Policy
Forum) will be held 22-24 February 2010, at The Fairmont, Washington D.C.

ISCTM
Carlotta McKee, 615-383-7688
Executive Director
isctm@isctm.org

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