How do pharmaceutical companies approach data from sexual health studies for regulatory agencies?
We briefly outline the importance of statistical input into clinical trial research in the pharmaceutical industry and in interactions with regulatory agencies, with particular concentration on the role of the statistician in projects on sexual health during Phases 2 and 3 of clinical trials required in bringing new drugs to the market.
Dilleen
Maria
M
Pfizer Global Research and Development, Sandwich, UK. maria.dilleen@pfizer.com
Haughie
Scott
S
D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D035061:Control Groups; D003661:Decision Support Techniques; D015195:Drug Design; D004341:Drug Evaluation / Q000379:methods*; D004345:Drug Industry / Q000458:organization & administration; D004363:Drug Utilization; D006801:Humans; D010349:Patient Compliance; D010352:Patient Dropouts; D012107:Research Design; D012735:Sexual Dysfunction, Physiological / Q000188:drug therapy; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy