AI Article Synopsis
- An industry survey was conducted by a PhRMA/FDA Working Group in 2002 to gather insights on active control trials for a non-inferiority workshop.
- The survey aimed to assess current practices in designing and analyzing active control studies and pinpoint regulatory guidance needs.
- Results were shared at a PhRMA workshop in November 2002, and this paper summarizes those findings.
Article Abstract
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.
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| http://dx.doi.org/10.1081/BIP-120037185 | DOI Listing |
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