Patient Perspective in Drug Development: Whose Opinion Counts Anyway?

1. Review the FDAs position on the incorporation of patients in drug clinical trials;
2. Describe comparative effectiveness research methodology that include the patient perspective;
3. Discuss the FDAs paradigm shift to include patient involvement in drug development.

Presentation includes information on:

Provide an overview on the FDAs shift in reviewing drug development, primary end points and drug indications in Phase II-IV randomized clinical trials.

Review the role of comparative effectiveness research and its methodology that includes patient participation

Identify how the patient’s involvement in drug trials and study design impact drug delivery, package insert and introduction to market