-The conduct of clinical trials falls within a strict regulatory framework. The objective of the round table was to develop reasonable recommendations for the implementation of GCP according to the type of research and taking in account the risks and challenges related to this research. Two types of risks have been identified: those related to the characteristics of the research and those related to the impact of the study results. The group designed an evaluation table of these risks. The round table focused its investigations on 3 main themes: monitoring, the investigational medicinal product and undesirable effects.

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Questions have been raised regarding the attractiveness of France versus other countries for performing clinical trials. A questionnaire was sent to pharmaceutical companies with offices in France to assess their level of activity and to get information on the pros and cons of performing phase I-IV international clinical trials in France. Eleven companies, of large to medium size and representing 44% of the shared market returned answers. In 2001, they spent 131 million euros on clinical trials -53% for phase I-III, with a staff of 1469 (not including Contact Research Organisations) -and involved 21 000 investigators recruiting 98 000 patients on local budgets, and 2257 investigators recruiting 10 270 patients on international budgets. France ranked well as regards size of market or resource availability, with an intermediate rank as regards costs, access to patients and disease prevalence, and was weak with regard to speed of recruitment and quality of investigators. Ways of improving France's attractiveness will be discussed.

Un essai clinique est destiné à obtenir des résultats répondant de façon crédible à la question posée sur un médicament ou une stratégie thérapeutique, sans faire courir de risques injustifiés aux personnes qui s'y prêtent.[1] La qualité de la conception, de la mise en oeuvre et du suivi d'un essai clinique conditionne d'une part la sécurité et la protection des personnes qui s'y prêtent et d'autre part la fiabilité des résultats obtenus sur un médicament ou une stratégie thérapeutique, que ces résultats fassent l'objet d'une publication et/ou d'un dossier d'autorisation de mise sur le marché (AMM).Pour la liste des participants, voir en fin d'article.Ce respect de la qualité s'organise et se contrôle par des procédures systématiquement appliquées, et correspondant à la mise en oeuvre des Bonnes Pratiques Cliniques (BPCs). [2] Le cadre règlementaire strict pour la réalisation des essais cliniques a récemment été modifié et harmonisé au niveau européen par la directive 2001/20/CE du 4 avril 2001 [3] « concernant le rapprochement des dispositions législatives, règlementaires et administratives des Etats membres relatives à l'application de Bonnes Pratiques Cliniques dans la conduite d'essais cliniques de médi-caments à usage humain ».Cette directive a fait l'objet d'une transposition en France dans la loi de Santé Publique du 9 août 2004 (livre 1 er , titre II duArticle published by EDP Sciences and available at

The use of subjective outcome measures for assessing drug efficacy varies according to the disease in question. Subjective outcome measures used to complement an objective outcome measure can clearly claim the status of a main outcome measure. The validation of an instrument follows an appropriate methodology that focuses on two points: the methods used for its construction are set out and its performance is evaluated in a study. In drug evaluation, the importance of the subjective outcome measure should be discussed, depending on the aim and the disease. The methodology of the study obeys the same rules as when an objective outcome measure is used. The issue of the clinical significance of the results should be broached and discussed. Subjective outcome measures deserve to be considered in the evaluation of the drug because they provide a different and complementary perspective on the disease and the patient, both at the time of obtaining the marketing authorisation or when reassessing a drug.