TL11: Head-to-Head Studies: Comparing risks/benefits, or, risking a comparison?
*CV Damaraju, J&J PRD, LLC
With the new health care reform law, there is increasing recognition to evaluate competing pharmaceutical products directly. Statistical challenges in designing head-to-head clinical trials are not simply confined to sample size and power calculations, but include selection of critical efficacy and safety endpoints where benefit/risk can be properly evaluated and effectiveness determined. Can one such trial be sufficient to decide the comparative effectiveness of a product? What are the risks associated with a potential negative finding for a commercial product from such a trial? What can be the regulatory role in formulating a framework for such a comparative effectivenss study?
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC