[Assessment and importance of clinical trial endpoints in various areas of medicine].
Numerous generic and disease-specific endpoints for clinical trials are available and in use. Standardised quality criteria for the assessment of endpoints have been developed which form the basis of many current reviews. In many clinical fields these endpoints were shown to pose major problems, though. These include a lack of standardisation and poor methodological quality, problems related to the applicability of endpoints and their limited appropriateness for specific research questions. In the meantime standardisation and harmonisation ecommendations have been developed (e.g., EMEA/FDA, RECIST, IMMPACT and OMERACT). In future, the selection of endpoints for clinical trials will have to be based on the specific research question (disease, hypothesis, intervention), taking account of recommendations, standardisations as well as harmonisations.
Ohmann
Christian
C
Koordinierungszentrum für Klinische Studien, Medizinische Fakultät, Heinrich-Heine-Universität Düsseldorf. christian.ohmann@uni-duesseldorf.de
D002986:Clinical Trials as Topic / Q000592:standards*; D004358:Drug Therapy / Q000592:standards*; D023381:Endpoint Determination / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy; D059408:Pain Management; D011785:Quality Assurance, Health Care; D012219:Rheumatology / Q000592:standards; D013514:Surgical Procedures, Operative / Q000592:standards