ASCO-ACCC Recommendations to Reduce Barriers to Clinical Trial Enrollment
Here is a summary of the strategies developed by ASCO and the Association of Community Cancer Centers (ACCC) to increase participation by minority patients in cancer clinical trials and ensure greater equity, diversity, and inclusion in research studies. For a detailed list of the recommendations, visit https://ascopubs.org/doi/full/10.1200/JCO.22.00754.
- Every person with cancer should have the opportunity to participate in a clinical trial: Leadership (administrative, clinical, and research) policies should embrace a culture of research, recognizing clinical trials as an integral component of comprehensive cancer care and prioritizing new strategies to promote this cultural shift.
- Trials should have an equity-focused design: All clinical trials should be designed to ensure that participants reflect the diversity of the patient population and that may benefit from the investigational treatment. The U.S. Food and Drug Administration, in collaboration with ASCO and Friends of Cancer Research, has issued guidance documents to promote broader eligibility criteria.1-4 The National Cancer Institute has integrated these broadened criteria into its protocol template.5
- Clinical trial sponsors, researchers, and sites should partner with patients, patient advocacy groups, and community leaders and groups: Institutions that actively engage with community leaders and groups increase equity, diversity, and inclusion enrollment in clinical trials.
- Educational and training programs should be continuous: Educational and training programs should have established efficacy, be completed routinely, include an evaluation, and enable participants to demonstrate improvements in cross-cultural and linguistic competencies; mitigation of bias; effective communication to build trust; and a commitment to achieving equity, diversity, and inclusion in clinical trials.
- Research stakeholders should invest in programs and policies that increase equity, diversity, and inclusion in clinical trials and in the research workforce: A strong commitment to cultural diversity and inclusiveness is reflected in an organization’s sustained investment in high-quality programs and resources that improve health outcomes and increase trial enrollment among racial and ethnic minority populations; and in staffing and hiring practices that create a diverse research workforce.
- Research stakeholders should share data and equity, diversity, and inclusionbest practices: Data collection and the sharing of best practices will help promote and sustain a culture of equity, diversity, and inclusion in trial infrastructure and implementation and will be necessary to document the effectiveness of interventions.
1. U.S. Food and Drug Administration: Cancer clinical trial eligibility criteria: Brain metastases. July 2020. Available at www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-brain-metastases. Accessed July 18, 2022.
2. U.S. Food and Drug Administration: Cancer clinical trial eligibility criteria: Patients with organ dysfunction or prior or concurrent malignancies. July 2020. Available at www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-patients-organ-dysfunction-or-prior-or-concurrent. Accessed July 18, 2022.
3. U.S. Food and Drug Administration: Cancer clinical trial eligibility criteria: Minimum age considerations for inclusion of pediatric patients. July 2020. Available at www.fda.gov/regulatory-information/search-fda-guidance-documents/cancer-clinical-trial-eligibility-criteria-minimum-age-considerations-inclusion-pediatric-patients. Accessed July 18, 2022.
4. U.S. Food and Drug Administration: Cancer clinical trial eligibility criteria: Patients with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infections. July 2020. Available at www.federalregister.gov/documents/2020/07/13/2020-14995/cancer-clinical-trial-eligibility-criteria-patients-with-human-immunodeficiency-virus-hepatitis-b. Accessed July 18, 2022.
5. Kim ES, Bruinooge SS, Roberts S, et al: Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research joint research statement. J Clin Oncol 35:3737-3744, 2017.
Research shows that although 15% of Black individuals and 13% of Hispanic individuals have cancer in the United States, only between 4% and 6% of clinical trial participants are Black and between 3% and 6% are Hispanic.1-3 To improve these statistics, in 2020, ASCO and the Association of Community...