The Results of Major Clinical Trials

Critical Assessment, the Circulation of Information and Media Coverage

¹ Laboratoires MSD, Paris, France
² Centre d'Investigation Clinique INSERM CHU de Nancy, Nancy, France

Abstract

The round table elected to focus its discussion on trials that, in terms of their importance, are likely to modify medical practices and behaviour. Such trials may be pre- or postmarketing studies. For the findings of a trial to result in a change in practice, they must be credible and fulfil the basic methodological criteria. It is nonetheless appropriate to complete that binary assessment by the use of an assessment checklist appropriate to each category of users, i.e. the Regulatory Agency, prescribing physicians and patients, who are sometimes informed directly by the media. The members of the round table proposed the "Giens 2003 checklist". It consists of an interpretative semi-quantitative assessment checklist based on simple messages relevant to practice. Critical assessment is a necessary prelude to the circulation of the results to the various parties involved (healthcare professionals, patients, patient associations, the media and the general public) and the process of informing those parties in readily understandable but accurate terms. The practical implementation of the results, with a change in behaviour and/or the issuing of guidelines, are subsequent stages for which a certain lag time is inevitable. The assessment of implementation programmes, together with an accurate analysis of the obstacles to changing medical practice, should, in the future, improve and accelerate the implementation of important results in order to optimise patient management.