Online Program Home
My Program

Abstract Details

Activity Number: 65
Type: Topic Contributed
Date/Time: Sunday, July 31, 2016 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #320886
Title: Regulatory Challenges in Evidence Synthesis in Cancer Clinical Trials
Author(s): Rajeshwari Sirdhara*
Companies: FDA
Keywords: cancer trials ; synthesis
Abstract:

In approving a product to treat cancer patients, the totality of information is considered. This information includes efficacy and safety results, availability of other treatment options, the population for which the treatment is intended, and other considerations. Both quantitative and qualitative data from different sources are synthesized in order to summarize the benefit and harm of the product that is being evaluated. In these type of synthesis, there are many challenges due to the objective and subjective nature of the components. In this presentation some of these challenges will be discussed.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2016 program

 
 
Copyright © American Statistical Association