SHOULD WOMEN TAKE PART IN CLINICAL-TRIALS IN BREAST-CANCER - ISSUES AND SOME SOLUTIONS

Purpose: The purpose of this review is to consider the issues for wome n related to participation in clinical trials that evaluate the manage ment of breast cancer and provide some recommendations for future init iatives to address the identified areas of concern. Methods: The Natio nal Health and Medical Research Council (NHMRC) National Breast Cancer Centre hosted an international workshop to address the question ''Cli nical Trials in Breast Cancer: Should Women Take Part?'' We also revie wed the literature on informed participation in clinical trials that w as identified in a broadly based search that covered Medline, PsycLIT, and HealthPlan from 1986 to 1996. Results and Conclusion: When women are asked to participate in a clinical trial, they are faced with a nu mber of questions and dilemmas. These include issues related to the co nduct and ethical considerations of the trial; the effect of participa tion or nonparticipation on treatment; the roles of the doctor as clin ician and as researcher; the process of informed consent; the timing o f the request for participation; and the benefits and costs of partici pation. A number al: steps are identified that could help worsen decid e whether to participate ill clinical trials, These include provision of community information about clinical trials; establishment of indep endent brokers and registers for clinical trials: consumer review of i nformation and protocols and involvement in trials; review of the role of ethics committees; collection of data about the proportion of wome n currently recruited to clinical trials, their reasons for participat ing or declining, and their views about the process of recruitment and participation; models for optimal practice ill recruiting women to cl inical trials and encouraging ongoing participation in trials; evidenc e-based communication skills training for clinicians to teach skills t o inform women adequately of clinical trial participation; and auspici ng and promotion of trials by an independent agency. (C) 1998 by Ameri can Society of Clinical Oncology.