VIEWPOINTS AND CONCERNS OF A CLINICAL-TRIAL PARTICIPANT

Most practicing oncologists are committed to the concept of prospectiv e clinical trials but, because of multiple logistic and perceptual det errents, actually enter only a small portion of their patients into su ch studies. Physician concerns include discomfort with placebo or ''no treatment'' randomizations, the burden of cumbersome monitoring of pr otocol patients, and fear of displeasing referring physicians. Patient s have difficulty accepting the uncertainty of randomized trials, part icularly those with a placebo arm. They resent the inconvenience and e xpense of extra visits and studies associated with protocol participat ion. Informed consent documents are often complex and their intent mis construed by patients. Rigorous eligibility requirements, although nec essary for accurate analysis, reduce accrual. Multiplicity of protocol s, with the resulting necessity to prioritize, rapid closure of Phase II studies for common tumors, and negative public attitudes reinforced by the media are significant deterrents to clinical trial participati on. Increasing accrual is a daunting challenge to the physician. Simpl ification of burdensome data collection, consent forms, and institutio nal review board procedures will reduce reluctance to participate. Mos t important, physicians must be educators, emphasizing the advantages of clinical trials to their patients and their families, their colleag ues, and the public.