SP06
Clinical Effectiveness: the challenge of selecting and combining key efficacy and safety endpoints as a single utility measure
Joseph T Wang
Charlie E. Barr, Pharmacia Corp.

As a lead biostatistician in a pharmaceutical company, the primary responsibility is to conduct clinically and statistically sound analyses to support and position the treatment drug. For comparing the treatment effect, selecting the key efficacy and safe ty endpoints requires not just the statistical knowledge, but also a thorough understanding of the disease, symptom, and drug effects. The pros and cons of using mean/median change from baseline, mean/median % change from baseline, and % of patients impr oved will be discussed using two leading over active bladder drugs, Detrol LA and Ditropan XL. A method of combining the key efficacy and safety endpoints to form a single utility measure to show the clinical effectiveness will be presented.