[Clinical researchers and the pharmaceutical industry. Usefulness and need for an independent steering committee].
Clinical trials for testing the efficacy of new drugs in patients are subject to guidelines issued by the European Union ('Good clinical practice'). These guidelines address, in great detail, the relationship between the physician-investigator and the patient, and also that between the sponsoring industry and the physician-investigator (a deplorable exception being the financial arrangement). A major omission is the lack of safeguards for an appropriate and robust design of the study. This applies to the choice of measures of outcome and possible subgroups, interim analyses and stopping rules, entry and management of data, and the final analysis. It is therefore mandatory that the sponsoring industry allows full and early participation by senior clinicians in the design and execution of a clinical trial, through a steering committee.
Van Gijn
J
J
Vakgroep Neurologie, Universitair Medisch Centrum, Utrecht.
Algra
A
A
D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D004345:Drug Industry / Q000458:organization & administration*; D005062:European Union; D006801:Humans; D009426:Netherlands; D017712:Peer Review, Research / Q000592:standards* / Q000639:trends; D012107:Research Design / Q000592:standards*
Klinisch onderzoekers en farmaceutische industrie. Nut en noodzaak van een onafhankelijke stuurgroep.