[Clinical drug trials. Regulation, coordination and significance of "Good Clinical Practice"].
All major drug agencies in the world have now implemented, or have at least shown interest in, Good Clinical Practice (GCP) standards as an important part of their regulation of clinical trials. This is increasingly considered as a logical part of drug regulation in general, because the data produced in trials will later be evaluated by the government agencies, and the quality of trials and data must therefore be assured. Another significant effect of GCP will be caused by the ties between ethics, public health and scientific standard referred to in many of the requirements. This means that GCP may eventually have an impact on the entire clinical research programme, including nonregulatory projects (possibly the majority), because the same standard must apply throughout. Harmonisation is well under way internationally for both GCP and clinical trial regulation. This should also extend to the handling of scientific misconduct, the influence of GCP on health economics and the establishment of ethics committee systems. International data bases may obviously be required. Finally, the ultimate goal, the benefit for patients and society, must not be obscured by the mechanics of improving clinical trials and the harmonisation of regulations, and the investigator should maintain a key position in clinical drug development under the new regulatory conditions.
Klinisk farmakologisk afdeling, Rigshospitalet, København.
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Hvidberg
D002986:Clinical Trials as Topic / Q000592:standards; D003718:Denmark; D017277:Drug Approval; D004341:Drug Evaluation; D004335:Drug and Narcotic Control; D015507:Drugs, Investigational; D004992:Ethics, Medical; D006801:Humans; D007391:International Cooperation
D015507:Drugs, Investigational
Klinisk laegemiddelafprøvning. Regulering, harmonisering og betydning af "Good Clinical Practice".