-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.
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.
RésuméL'utilisation de critères subjectifs d'évaluation de l'efficacité est variable selon les pathologies. Les critères subjectifs utilisés en complément de critères objectifs peuvent tout à fait prétendre au statut de critère principal d'efficacité. La validation d'un instrument suit une méthodologie appropriée portant sur deux points : l'exposé des modalités pratiques de sa construction et une étude permettant d'évaluer ses performances. Lors de l'évaluation du médicament, la place du critère subjectif doit être discutée, en fonction de l'objectif et de la pathologie. La méthodologie de l'étude obéit aux mêmes règles que lorsqu'on utilise un critère objectif. La question de la significativité clinique des résultats doit être abordée et discutée. Les critères subjectifs méritent d'être pris en compte dans l'évaluation du médicament apportant un éclairage différent et complémentaire sur la maladie et sur le patient, que l'on soit au moment de l'autorisation de mise sur le marché ou en situation de réévaluation.
The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations:• In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]).• To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)].• To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority.• To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent.• To follow the recommendations posted on the Afssaps website for the entire IMP dossier.• To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees.• To limit the 'substantial' amendments to those provided for in the European guidelines.• To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies.All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France.
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