[Evaluation of patient information sheets in clinical trials].
When an investigator invites a patient to take part in a clinical trial, he explains the purposes and details of the trial and gives him an information sheet. We decided to assess this information comparing it with the Huriet-Serusclat law and ICH norms. Seventy four information sheets from phase II and III trials were analysed. The research setting is always specified whereas the aim of the trial is presented in 96% of cases. The sequence of events is detailed in 76% of cases, and the benefits two times out of three. The text is often presented in only one paragraph and the average number of pages is about 2.6. For 25 percent of cases, information is lacking with regard to the progression of the trial; in other cases, the sheets are too long and patients are lost in an excess of information. Information sheets in clinical trials must be practical and short and rely on ICH recommendations.
Frimas
V
V
Pharmacie-CHU Côte de Nacre, Caen, France.
Chedru-Legros
V
V
D002986:Clinical Trials as Topic / Q000379:methods*; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D004282:Documentation; D005568:Forms and Records Control; D006801:Humans; D010361:Patients