Clinical trial designs: is it possible to have a unified approach and common end points?
The accelerating development during the last 5 y of new compounds for the medical treatment of erectile dysfunction (ED) demands standardized high-quality protocols for evaluation of the therapeutic effect of these treatments. Outcome analyses have to rely on prospective, placebo-controlled trials within predefined populations, where the results are based on good biostatistics, self-administered questionnaires that include partner assessments, quality-of-life measures, and treatment satisfaction. Currently, we have access to different drug application procedures for clinical use in the treatment of ED, and soon we will have new competitive analogues for optional oral treatment. From a wider perspective, we will naturally see second- and third-generation compounds and drugs related to different effector mechanisms. In many subpopulations, ED has a close relation to specific comorbidities, such as cardiovascular diseases and diabetes. Regarding these aspects, the baseline for all clinical trials should be unified and structured not only to evaluate the clinical outcome assessment (subjective and objective) and adverse events as end points, but also to relate the defined therapeutic response to good current clinical practice.
Hedlund
H
H
Department of Urology, The National Hospital, University of Oslo, Oslo, Norway. h.e.m.hedlund@klinmed.uio.no
D002986:Clinical Trials as Topic / Q000379:methods*; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D008297:Male; D017060:Patient Satisfaction