Gotay C C
National Cancer Institute, Division of Cancer Prevention and Control, Bethesda, MD 20892.
Soc Sci Med. 1991;33(5):569-77. doi: 10.1016/0277-9536(91)90214-w.
Although randomized clinical trials are the predominant method used to evaluate cancer therapies, only a small proportion of potential participants actually enter onto trials. This paper analyzes the research literature on accrual to cancer therapy trials. The research shows that nonparticipation is influenced by physician and patient variables, as well as by characteristics of the specific protocols. Trials design, especially pre-existing treatment preferences, pose significant problems for physicians and patients. Intervention strategies have focused on alternate trial designs, improving the informed consent process, and increasing knowledge about trials. Additional research should focus on the perspectives of patients who accept and decline trial participation and on interventions designed to affect accrual. Future studies need to be sensitive to patient quality of life considerations as well as practical and ethical issues.
尽管随机临床试验是评估癌症治疗方法的主要手段，但实际上只有一小部分潜在参与者真正进入试验。本文分析了有关癌症治疗试验入组情况的研究文献。研究表明，不参与受医生和患者变量以及特定方案特征的影响。试验设计，尤其是预先存在的治疗偏好，给医生和患者带来了重大问题。干预策略集中在替代试验设计、改进知情同意程序以及增加对试验的了解。进一步的研究应关注接受和拒绝试验参与的患者的观点以及旨在影响入组的干预措施。未来的研究需要关注患者生活质量方面的考量以及实际和伦理问题。
