Accrual to Breast Cancer Clinical Trials at a University-Affiliated Hospital in Metropolitan Detroit

Abstract

Despite the large number of available studies, most women with breast cancer do not participate in clinical trials, and this is especially true among lower income and minority women. In this study the authors surveyed the practice patterns of four medical oncologists who comprised the clinical breast service at a large urban university hospital to develop a better understanding of the clinical trials enrollment process for women with breast cancer. Of 136 new female breast cancer patients seen by the four physicians over a 7-month period, there were 47 women (34%) offered participation in a clinical trial, and 16 women (12%) were eventually enrolled. Women who were offered participation were more likely to be younger (p = 0.068) and to have earlier stage disease then were women not offered participation (p = 0.008). Women enrolled into a trial were also more likely to be younger, although this difference was not statistically significant (p = 0.114). Patient race was not associated with the accrual or enrollment process. Over half of the women were not offered participation in clinical trials because of the lack of available studies. Further work evaluating the process of patient enrollment and physician and patient barriers is necessary to develop effective strategies for recruitment into breast cancer clinical trials.

Consent Timing and Experience: Modifiable Factors That May Influence Interest in Clinical Research

“…Numerous studies have demonstrated racial disparities in clinical trial accrual [7][8][9] ; our results suggest that these differences may in part reflect access to trials or reservations about specific study procedures, 25 rather than a general aversion to clinical research. Consistent with previous reports, 26,27 older patients in this cohort seemed less willing to be recruited for future research studies.…”

An examination of the influence of patient race and ethnicity on expressed interest in learning about cancer clinical trials

“…EVorts to understand why minorities in the US are frequently underrepresented in the conduct of clinical trials have identiWed a number of important issues likely to contribute to the current state-of-aVairs, including socioeconomic factors, insurance coverage, mistrust of the medical and research establishments, inadequate awareness of relevant studies, and lack of access (Lara et al 2005;Moreno-John et al 2004;McCaskill-Stevens et al 1999;Simon et al 1999;Lai et al 2006). Clearly, no simple "Wx" to solve this vexing problem will be found.…”

The Role of Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies

“…Studies have found that a common reason for patient ineligibility to available protocols is narrow eligibility criteria. 3,14,21,22,23,24 Trial eligibility attempt to satisfy two opposing criteria. On the one hand, eligibility must be sufficiently narrow to produce a treatment effect that is approximately consistent across the cohort.…”