Vrhovac R, Francetić I, Rotim K
Department of Medicine, University Hospital Rebro, Zagreb, Yugoslavia.
Int J Clin Pharmacol Ther Toxicol. 1990 Sep;28(9):375-9.
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.
1988年12月至1990年2月期间,采用问卷调查法对97名参与临床药理学单位不同临床试验(III期和IV期)的健康志愿者进行了访谈。调查目的是分析受调查者的职业分布、对所参与试验的了解程度、对所获报酬的看法以及对众多试验因素重要性或不便之处的估计。只有39名志愿者(40.2%)是医务人员:17名(17.5%)医生、17名(17.5%)医学生和5名(5.2%)护士。志愿者对与试验相关的不同因素的重要性进行了1至5分的评分。他们更担心试验期间可能出现的药物不良反应(ADR)(中位数3.87),而不是试验后可能出现的(2.94)。他们对所研究药物的种类(3.49)非常关注。其次是“试验对医学和社会的潜在贡献”(3.30)和“在实验室花费的时间长度”(3.17)。本文结尾讨论了在南斯拉夫对健康志愿者进行临床试验的情况和法律法规。