An industry survey on current practices in the design and analysis of active control studies.
An industry survey was conducted by a PhRMA/FDA Working Group on Active Control Trials in the summer of 2002 in preparation for a non-inferiority workshop sponsored by the Pharmaceutical Research and Manufacturers Association (PhRMA). Its objective was to understand the industry practices in the design and analysis of active control studies and to identify areas where regulatory guidances are most needed. The survey was sent to all major research-based pharmaceutical companies that were members of PhRMA in April 2002, and results were presented at a PhRMA workshop, held in Washington, D.C., on November 4-5, 2002. This paper is a written summary of the survey findings.
Chuang-Stein
Christy
C
Statistical Research and Consulting Center, Ann Arbor Laboratories, Pfizer Inc., Ann Arbor, Michigan 48105, USA. christy.j.chuang-stein@pfizer.com
Sanders
Corsee
C
Snapinn
Steve
S
D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection / Q000706:statistics & numerical data*; D004345:Drug Industry / Q000592:standards* / Q000706:statistics & numerical data*; D006801:Humans