Introduction Philip Sager, MD (Consultant/Stanford Univ)
Session I
CV Outcome Studies to Determine Drug Safety
Session Chairs: Peter Kowey, MD and Jonathan Seltzer, MD
· Overview of their role, findings, impact, and challenges Peter Kowey, MD (Lankenau)
· CV Safety Assessments
o FDA Perspective Patrick Archdeacon, MD (Office of Medical Policy, FDA)
· Low prevalence events when there is not a clear safety signal
o The role of individual dedicated CV studies versus monitoring throughout drug development when prevalence rates are expected to be low; How much unknown risk is acceptable at the time of approval? Nancy Geller, PhD (NIH\NHLBI)
o Value of information analysis and statistical approaches to studying CV Safety Mark Hlatky, MD (Stanford University)
· What factors should be considered when deciding if pre-approval outcome studies are required? William White, MD (University of Connecticut)
· Benefit:risk analysis- qualitative vs quantitative analysis William Hiatt, MD (University of Colorado)
*Discussion*
Session II
Discussion of Specific Examples: Lower and higher risk populations [Each speaker to address a few specific questions (see end of agenda)]. Considerations- What do the past examples show? What can we learn to apply to future CV safety questions and their evaluation?
Session Chairs: Philip Sager, MD and Bob Temple, MD
· Why was a CV Outcomes trial not required for Aliskiren based on the Altitude trial results? Mary Ross Southworth, PharmD (FDA)
· Discussion of the CV safety approach for the assessment of varienicline (Champix) and potential implications. Judith Prochaska, PhD (Stanford)
· Do the sibutramine data support the need to perform a CV Outcome Safety Studies for all drugs to treat obesity? Domenic Sica, MD (Medical College of Virginia)
· Tegaserod: Is the data sufficiently compelling for a class effect and thus a CV Outcome Safety should be required for all 5HT-4 agonist for severe constipation? Jeff Anderson, MD (Intermountain Healthcare)
o FDA Perspective Joyce A. Korvick, M.D., M.P.H.
· Tiotropium: Do the findings of a CV safety signal in the meta-analyses have implications for all drugs to treat COPD? Lorcan McGarvey, MD (Queen’s University)
o FDA Commentary Sally Seymour , MD (FDA)
· Do dronedarone data supported the need to perform a CV Outcome Safety Study? Gerald Naccarelli, MD (Hershey Medical Center)
o FDA Commentary Norman Stockbridge, MD, PhD
· Does the rosiglitazone experience and the new label lessons learned? Murray Stewart, M D (GSK)
Session III
Alternative Approaches To Randomized Prospective CV Outcome Studies To Evaluate Drug Safety
Session Chair: Chairs: William White, MD (Univ of Connecticut), Rick Turner, PhD (Quintiles)
· What is the potential for impact on Phase 3 development if CV Safety can be well defined in the early post-approval period? How might new technologies impact assessment of the benefit: risk relationship Robert Temple, MD (FDA)
· The approach and potential impact of the Sentinel effort on drug development Marsha Reichman, MD (FDA)
· The use of registries and electronic medical records to evaluate post-approval drug safety Kathleen Hewitt, MSN, RN
· Observational studies- current examples Leroy LeNarz, MD (Eli Lilly)
*Discussion*