[Clinical trial of drugs: a study of the influence of information on adverse reactions on obtaining of informed consent].
BACKGROUND
One of the factors that might influence a subject when making his decision on his possible participation in a clinical trial (CT), is the amount of information supplied to him concerning the adverse reactions of the drug being investigated.


METHODS
In order to assess this aspect, we performed a mock trial, designed as a phase 1 CT, among university students. We drew up two documents (A and B) containing the minimum information concerning the "CT" and the "drug under investigation". Both documents were exactly the same except that document A indicated the reduced information about the adverse reactions of isoniazide as per the Spanish Vademecum, whereas document B contained the much more extensive and detailed data indicated in the US PDR. These documents (A and B) were read and handed over to the students, divided in two groups A and B, respectively. The students who ignored at every moment that it was a mock "CT", had to decide, in writing and anonymously, whether they were ready or not to participate in the CT.


RESULTS
306 university students, 148 of the School of Medicine and 158 of Telecommunications participated. In groups A (n = 160) and B (n = 146), 49% and 47% belonged to the School of Medicine, respectively. 10.6% of the subjects of group A accepted to participate in the "CT", against 4.1% of those of group B, which shows a statistically significant difference (p less than 0.05).


CONCLUSIONS
It is concluded that the amount of information about adverse reactions supplied to the possible participants in a CT, is a factor that influences the recruitment rate.
Dal-Ré
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Departamento de Investigación Clínica, Smith Kline Beecham Pharmaceuticals, Madrid.
D000328:Adult; D002986:Clinical Trials as Topic; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007258:Informed Consent; D007538:Isoniazid / Q000009:adverse effects; D008297:Male; D013030:Spain; D013334:Students; D013337:Students, Medical
D007538:Isoniazid
Investigación clínica con fármacos: estudio de la influencia de la información sobre reacciones adversas en la obtención del consentimiento informado.