Building a Framework for Equity Enrollment in Oncology Trials

for minority research subjects. In some cases, bilingual consent forms may be helpful. Education of clinical research participants can be enhanced by having prospective research subjects visit the FDA’s new Patient Network Website, www.patientnetwork.fda.gov, to read a current newsletter and attend monthly FDA Basic Webinars, which are followed by a Q&A session with a senior FDA representative. Additionally, an annual Patient Network meeting is scheduled, and this year’s September 2013 meeting is entitled, “Demystifying the FDA.” Training health professionals to provide culturally and ethnically oriented service to patients26 may help them be more aware of the needs of minority or underserved populations. Patient counselors or navigators can educate patients about treatment options, help them negotiate the healthcare system, and help eliminate barriers to treatment. Participant navigation can be crucial to full patient participation, especially when patients form a closer association with the navigator than the investigator. Having a team approach that comprises various health professionals as well as other medical caregivers can help patients more easily manage a coordinated research and medical pathway. Conclusion » In oncology research, minorities and underserved populations have low participation rates in spite of bearing a disproportionate burden of disease. Reversing the trend of low participation will require removing barriers to participation that start with awareness of clinical research and continue through fulfilling extensive protocol procedures. To increase enrollment by minorities and underserved patients, consideration of specific barriers and solutions to them should be considered during the study design phase of a clinical trial. Using the conceptual model of the accrual process for patient decision-making can be helpful for developing agendas to reduce disparities in research. Author Bio » Barbara Geiger, BSN, RN Executive Vice President, Oncology and Latin America, Clinipace Worldwide Barbara Geiger has been in the clinical research and development industry for over 25 years. She is an executive clinical operations professional with extensive experience in oncology and CNS drug development. clinipace.com 8

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