[Methodological analysis of phase IV clinical trials performed in hospital based on the Huriet Law ].
Since the implementation of the 'Huriet law', drugs in phase IV clinical trials are handled by the pharmaceutical Department of the 'Hôpital Neuro-Cardiologique' (Lyon, France). The methodology of these trials is assessed by using a special assessment grid which enables a score for each protocol, with a maximal score of 20 and a minimal one of minus 20. Although many limitations could be advanced, results of this study show that, among 39 assessed trials, 13 trials had weak methodology (score < or = 0), 16 are middle-quality trials (score between 0 and 10) whereas 10 trials only can be considered as having a strong methodology (score > 10). So, a fairly large number of the organized phase IV trials have debatable quality. Moreover, their objective is questionable, that is essentially promotional, in spite of the 'Huriet law' and Persons Protection Committees.
Goubier-Vial
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C
Service Pharmaceutique, Hôpital Neuro-Cardiologique, Lyon, France.
Ferry
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D017327:Clinical Trials, Phase IV as Topic / Q000331:legislation & jurisprudence* / Q000379:methods*; D017041:Ethics Committees; D005602:France; D006801:Humans; D007882:Legislation, Hospital
Analyse méthodologique des essais cliniques de phase IV entrepris à l'hôpital après la loi Huriet.