Paul Meier as a National Spokesman for Good Science: His Roles in AIDS Research and as an FDA Advisor

• Activity Number: 550
• Type: Invited
• Date/Time: Wednesday, August 1, 2012 : 2:00 PM to 3:50 PM
• Sponsor: Memorial
• Author(s): Susan S Ellenberg*+
• Companies: University of Pennsylvania

Abstract

Paul Meier was one of the strongest, most articulate and most respected voices demanding rigor in the design, conduct and interpretation of clinical trials throughout his professional life, in his roles as a trial statistician, data monitoring committee member, invited speaker at national/international meetings, and as a formal advisor to the National Institutes of Health, the Food and Drug Administration, and the National Academy of Science. His insistence on the need for proper design and analytical methods was enormously influential in the regulatory arena; he served terms on two different advisory committees and participated in many others, being invited when particularly difficult decisions were clearly in the offing. He was particularly influential in regard to the testing of drugs to treat AIDS. His message about the importance of rigorous trial design and conduct to show that drugs really worked was not lost on AIDS activists who, although pushing for more rapid access to promising drugs, recognized the folly of making widely available many treatments that did not