29 Dec Clinical Trial Enrollment: Racial & Ethnic Enrollment Differences
MedicalResearch.com Interview with:
Aisha T. Langford, PhD, MPH
VA Health Services Research and Development Service & U-M Center for Bioethics and Social Sciences in Medicine
Ann Arbor, MI 48109
MedicalResearch.com: What are the main findings of the study?
Dr. Langford: The main and perhaps most interesting finding was that there were no racial/ethnic differences in cancer clinical trial enrollment, refusal rates, or “no desire to participate in research” as the reason given for clinical trial refusal; however, patients over the age of 65 had lower odds of being enrolled in a clinical trial. Additionally, higher odds of having physical/medical conditions were associated with older age, males, and non-Hispanic blacks.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Langford: It was a bit surprising to find that a higher grade level score for consent form readability (OR = 0.9, 95% CI = 0.83-0.97) was significantly associated with lower refusal rates and that consent page length ≥ 20 was significantly associated with lower odds of “no desire to participate in research” among clinical trial decliners (OR = 0.75, 95% CI = 0.58-0.98).
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Langford: Better management of physical/medical conditions before and during treatment may increase the pool of eligible patients for clinical trials. Additionally, we should be cautious about assuming that racial/ethnic minorities are less willing to participate in cancer clinical trials. The racial/ethnic disparity in clinical trial participation overall may be due to logistical factors such as the characteristics of a clinical trial, patients being excluded because of co-morbidities, and clinicians not offering clinical trials to all patients.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Langford: Future work should examine the role of comorbidities, sex, age, and consent form characteristics on clinical trial participation. Additionally, future work should evaluate the impact of provider preferences and biases in the context of offering clinical trials. Although we did not fully explore physician characteristics and patient clinical trial participation, the primary reasons that MDs declined offering a trial to an eligible patient were preference for standard of care and concerns about the patient?s ability to tolerate a clinical trial due comorbidities/ frailty.
Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program
Langford, A. T., Resnicow, K., Dimond, E. P., Denicoff, A. M., Germain, D. St., McCaskill-Stevens, W., Enos, R. A., Carrigan, A., Wilkinson, K. and Go, R. S. (2013), Racial/ethnic differences in clinical trial enrollment, refusal rates, ineligibility, and reasons for decline among patients at sites in the National Cancer Institute’s Community Cancer Centers Program. Cancer. doi: 10.1002/cncr.28483