How to Improve Clinical Research Performances in France?

Abstract

-The general objective of this study was to proceed an inventory of measures which could help to improve the efficiency of clinical research in France. Method. Thanks to the discussion between the members of the round-table conference (composed of medical doctors (MD)/investigators; hospital managers; representatives of industrial promoters; general practitioners...), we have looked over the difficulties that meets clinical research in France nowadays. Results. We identified four fields of action: 1) availibility of resources for carrying out the trials in time and in quality; 2) feasability of the clinical trials, in their design and for the recruitment which depends on both of the investigation centers and patients (what is the image of human testing in the society?); 3) skills and motivation of all the elements of staffs in charge of clinical trials (MD; nurses; and the new jobs in medical research); 4) promptness and efficiency of the administrative organisation for a fast starting up of the trials. Conclusion. This study, which doesn't pretend to sufficiency, shows the gap of improvement for French clinical trials organisation.From the outset, it seemed important to specify the meaning given to the term "performance" in the workshop. Indeed, we must distinguish the actual research objective and its results, making it possible to reach a scientific hypothesis, from its operational dimension, leading to the satisfaction of a certain number of internationally acknowledged criteria, which define France's level of appeal in comparison countries undertaking these same activities and in a context of international competitiveness. This roundtable focussed on the second dimension.The first discussion then looked at identifying major guidelines for improving clinical research. Four factors emerged:1. The availability of the resources needed to conduct research protocols (availability in quantity and on time in the shortest time limits). 2. The feasibility of the trial protocol design and recruitment depending on the centre/team/investigation network (recruitment commitment) and patients and the image they have of biomedical experimentation.For a list of participants, see the end of the article.3. The qualifications and motivations of associated individuals and professions that comprise the team leading the research protocols. 4. The flexibility and efficiency of the administrative organisation with regards to the shortest preliminary trial preparation times.For each of the factors conditioning trial fulfilment in scheduled time limits and expected quality standards, the working group has drawn up a certain number of recommendations enabling the current situation to be improved.

Optimization of the Inclusion of Alzheimer's Disease Patients in International Multicenter Randomized Trials: Results of a National Survey Conducted in Memory Research Centers in France

“…Galvin et al [ 14 ] showed that inadequate procedures and the framework of opinion about the process of inclusions are both predictors of inclusion: OR 4.7, 95% CI (12-18.7), OR 6.8, 95% CI (1.4-32.3). Diebolt and Pletan [ 19 ] clearly showed that the internal organization of research centers in France has major deficiencies particularly with regard to bureaucracy and lack of motivation of practicing physicians in the centers. They do not feel involved in the procedures because of a lack of staff meetings or information on research concerning upcoming clinical trials or the progress of trials already underway.…”