[Drug clinics. Clinical drug trials: the importance and role of the general practitioner].
Clinical trials are an essential step in the development of a drug. They must be conducted according to strict rules called "Good Clinical Practice" or GCP. GCP requirements aim to guarantee a perfect methodology in the planning, realization and interpretation of clinical trials. The latter can be divided in four phases: phase 1 aiming to demonstrate the safety and to investigate the pharmacokinetics/metabolism of the drug in healthy volunteers; phase 2 aiming to study the intrinsic activity (generally versus a placebo) and safety of the compound in a rather small number of (hospitalized) patients; phase 3 aiming to confirm the comparative efficacy (versus a placebo or a reference drug) and safety of the pharmacological agent in a quite large number of (ambulatory) patients; and phase 4 carried out after commercialization, to verify the clinical utility of the drug in conditions of daily practice. Because he/she occupies a crucial position in the recruitment and follow-up of outpatients, the general practitioner should play a more active role in clinical trials, provided that he/she could work in collaboration with academic centers specialized in clinical pharmacology which can help to perform studies in accordance with GCP requirements.
Scheen
A J
AJ
Service Associé, Université de Liège.
D000046:Academic Medical Centers; D000553:Ambulatory Care; D002986:Clinical Trials as Topic; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D004358:Drug Therapy; D005194:Family Practice; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D008297:Male; D018579:Patient Selection; D004364:Pharmaceutical Preparations / Q000378:metabolism; D010599:Pharmacokinetics; D010601:Pharmacology, Clinical; D010919:Placebos; D017410:Practice Guidelines as Topic; D012107:Research Design; D012449:Safety
D004364:Pharmaceutical Preparations; D010919:Placebos