This discussion thread was created to help organize information and links related to adaptive approaches to the design and analysis of clinical trials.

For more information about the working group, visit its web page at
http://biopharmnet.com/doc/doc12004.html.

Alex Dmitrienko

Last edited by BioPharmNet on Fri May 18, 2007 2:06 pm; edited 1 time in total

The briefing documents (from GSK and FDA) for the May 1 Pulmonary AC meeting to discuss GSK's advair diskus are posted at
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4298b1-00-index.htm
The pivotal study to study the survival benefit of advair has built-in sample size re-estimations and interim analyses.

The following is extracted from page 4 of the FDA's briefing document: "The original sample size was 3800 to detect a 5% difference in the primary endpoint with an 80% power. This sample size was calculated based on the assumption of a 20% placebo mortality in patients with a FEV1 of <60% (from a prior study). The assumption was modified and two re-estimations of the sample size were done such that the final sample size was 6040. This sample size provided 90% power to detect a 4.3% difference in the primary endpoint."

Christy Chuang-Stein