Drug trials on healthy volunteers in Yugoslavia.
Ninety-seven healthy volunteers who participated in different clinical trials (phases III and IV) in a clinical pharmacology unit were interviewed over the period December 1988-February 1990 using questionnaire method. The aim of the investigation was to analyze the examinees' occupational distribution, the degree of insight in the trials they participated in, their opinion about the remuneration they get and their estimate of the importance or inconveniences of numerous trial elements. Only 39 volunteers (40.2%) were members of medical staff: 17 (17.5%) physicians, 17 (17.5%) medical students and 5 (5.2%) nurses. The volunteers assessed the importance of different elements related to the trial marking them from 1-5. They were more afraid of possible adverse drug reactions (ADR) occurring during the trial (median 3.87) than of those that might occur afterwards (2.94). Significant was their concern about the kind of investigated drug (3.49). "Potential contribution of the trial to the medicine and society" (3.30) and "length of time spent in the laboratory" (3.17) followed. The conduct of clinical trials on healthy volunteers in Yugoslavia and legal regulations are discussed at the end of the paper.
Vrhovac
R
R
Department of Medicine, University Hospital Rebro, Zagreb, Yugoslavia.
Francetić
I
I
Rotim
K
K
D000328:Adult; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards*; D004358:Drug Therapy; D005260:Female; D006801:Humans; D008297:Male; D010353:Patient Education as Topic; D011795:Surveys and Questionnaires; D015022:Yugoslavia