Public Information about Clinical Trials and Research

¹ Pfizer, Paris, France
² CIC-INSERM-CHU Nancy, France
³ CHU Saint-Antoine, Paris, France

Received: 6 May 2003
Accepted: 23 May 2003

Abstract

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.