Reference : Pharma-Clinics. Essais cliniques medicamenteux: importance et role du medecin general...
Scientific journals : Article
Human health sciences : General & internal medicine
Human health sciences : Pharmacy, pharmacology & toxicology
Pharma-Clinics. Essais cliniques medicamenteux: importance et role du medecin generaliste .
[fr] Drug clinics. Clinical drug trials: the importance and role of the general practitioner
Scheen, André mailto [Université de Liège - ULiège > Département des sciences cliniques > Diabétologie, nutrition et maladie métaboliques - Médecine interne générale >]
Revue Médicale de Liège
CHU de Liège
Yes (verified by ORBi)
[en] Academic Medical Centers ; Ambulatory Care ; Clinical Trials as Topic ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Clinical Trials, Phase IV as Topic ; Drug Approval ; Drug Evaluation ; Drug Therapy ; Family Practice ; Female ; Follow-Up Studies ; Hospitalization ; Humans ; Male ; Patient Selection ; Pharmaceutical Preparations/metabolism ; Pharmacokinetics ; Pharmacology, Clinical ; Placebos ; Practice Guidelines as Topic ; Research Design ; Safety
[en] 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.

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