Clinical Trials

Any paper addressing research needs and disparities in health care could not conclude without examining the issue of clinical trials enrollment. For women with highrisk and metastatic breast cancer, trials represent an important strategy for optimal care that can offer early access to new treatments prior to FDA approval, as well as to the cooperative group protocols that represent ongoing refinements of already approval treatments. An argument can be made that trial participation is also indicative of a sense of connection to the medical and research communities, as well as showing a commitment to the goal of furthering research and to the patient's own treatment goals.

Participation in clinical trials among adult cancer patients has long been known to comprise only a small percentage of patients. A National Cancer Institute study found that “more than 70 percent of cancer patients aged 0–19 years are estimated to enter cooperative group clinical trials compared with 4 percent of cancer patients aged 20–49 years and 1.5 percent of patients aged 50 years or older.”64 The high participation in pediatric clinical trials is often related to the rapid development and relative success treating of childhood cancers. A report prepared by the Minority-Based Community Clinical Oncology Program (MBCCOP) found that “While minority patients are willing to participate in clinical trials, there are profound barriers involving language, logistics, and the appropriateness of available protocols.”65

According to the authors of one recent University of California survey done of causative factors for low trial participation, “Low accrual rates clearly have a negative impact, often prolonging the duration of the trials, delaying the analysis of important results, or leading to early close of important studies.”66 Even in this research institution, clinical trials were not widely offered to patients. One-third of the time physicians didn't mention clinical trials to their patients, either because of false perceptions about lack of available protocols or the patient's poor performance status. Nearly half of eligible patients surveyed refused to participate in trials because of travel concerns, fear of experimental therapies and of being randomized, and problems with insurance reimbursement. Reasons given for lack of minority participation cited elsewhere have been lack of opportunity, mistrust of the white-dominated health care system, and lack of information about trials.67

Clearly, more needs to be done in California, as elsewhere, in furthering enrollment in clinical trials so that more patients of all ages, socio-economic status, races and ethnic groups can participate. Research must build on existing studies to explore the barriers to trial participation as a necessary step.