| Autor: |
Yannick Plétan, Faïez Zannad, Patrice Jaillon, E. Autret-Leca, Ch. Belorgey, M. Bernard-Harlaut, D. Cellier, F. Chazelle, M.F. Chevallier-Le Guyader, M. Couderc, D. Debiais, J. D’Enfert, A.M. Duguet, L. Fleury, M. Gallard, A. Giacomino, Y. Juillet, H. Kolsky, J.P. Lehner, F. Lemaire, M.F. Padioleau, M. Peschanski, S. Ravoire, J.P. Reynier, Ph. Ricordeau, P. Sassano, C. Sibenaler, M.C. Simon, J. Soletti |
| Rok vydání: |
2003 |
| Předmět: |
|
| Zdroj: |
Therapies. 58:197-208 |
| ISSN: |
0040-5957 |
| Popis: |
Be it to restore the confused image of clinical research in relation to the lay public, or to develop new ways of accruing healthy volunteers or patients for clinical trials, there is a need to draft some guidance on how best to provide information on research. Although the French legal and regulatory armamentarium in this area is essentially liberal, there is currently little-justified reluctance among study sponsors to advertise publicly. A group of academic and pharmaceutical industry researchers, assembled for a workshop, together with regulators, journalists, representatives from ethics committees, social security, patient and health consumer groups and other French institutional bodies, has suggested the following series of recommendations: – there is no need for additional legal or regulatory constraints; – sponsors should be aware of and make use of direct public information on trials; – a ‘good practice charter’ on public communication about clinical trials should be developed; – all professionals should be involved in this communication platform; – communication in the patient’s immediate vicinity should be preferred (primary-care physician, local press); – clinical databases and websites accessible to professionals, but also to patients and non-professionals, should be developed; – genuine instruction on clinical trials for physicians and health professionals unfamiliar with such trials should be developed and disseminated; – media groups should receive at least some training in the fundamentals of clinical research. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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