Cancer organizations issue recommendations to increase clinical trial diversity
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ASCO and the Association of Community Cancer Centers have jointly developed recommendations for improving equity, diversity and inclusion in cancer clinical trials.
The recommendations, published in Journal of Clinical Oncology, include actions the cancer clinical trial community can take to increase participation of underrepresented individuals.
“The lack of diversity in clinical trials is a persistent challenge, caused by a variety of factors,” Lori J. Pierce, MD, FASTRO, FASCO, vice president for academic and family affairs and professor of radiation oncology at University of Michigan, said in an interview with Healio. “This is not something that can be easily solved by one person or one organization acting alone. Our recommendations were developed to be comprehensive, with clear, concrete actions for every stakeholder to take to help expand the participation of underrepresented individuals in research.”
Slow progress
Despite an increased focus on diversity, equity and inclusion (EDI) in clinical trials, change has been slow. According to ASCO, although Black individuals comprise 15% of patients with cancer and Hispanic individuals represent 13% of these patients, only 4% to 6% of trial participants are Black and 3% to 6% are Hispanic.
“One of the biggest barriers to trial participation is that trials are not consistently offered to people,” Pierce said. “We know that most patients who are eligible and offered cancer trials accept, and a study by Unger and colleagues found that there were no differences in acceptance rates between patients who are Black vs. those who are white.”
The recommendations focus on major barriers to cancer clinical trials and resulted from a literature review and ASCO-ACCC Steering Group consensus discussion.
“The recommendations followed an intensive review of the literature and consultation with national experts who are part of the project’s steering group,” Randall A. Oyer, executive medical director of Ann B. Barhsinger Cancer Institute and Cancer Services and clinical professor of medicine at Perelman School of Medicine at the University of Pennsylvania, said in an interview with Healio. “We also included a skilled and thoughtful patient advisory group, as well as our organizational and personal perspectives.”
Key recommendations address the following:
- Clinical trial access: Research sites and clinical practices should screen all patients for trials and regularly gather and analyze data according to patient demographics, including race and ethnicity, to ensure all have an opportunity to participate.
- Equity-focused design: Sponsors and investigators of clinical trials should design and conduct trials with an emphasis on reducing barriers and increasing participation of underrepresented populations.
- Partnerships among stakeholder groups: Clinical trial sponsors and investigators should form long-term relationships with patients, advocacy groups and community leaders.
- Continuous education and training: Designers of clinical trials should complete continuing education, training and assessment on cross-cultural competencies, bias mitigation, effective communication/trust and commitment EDI in trials.
- EDI investment: Stakeholders in research should invest in programs and policies that enhance EDI in clinical trials and among researchers.
- Data and strategy sharing: Research stakeholders should compile and publish cumulative data on racial and ethnic diversity of trial participants when reporting results.
‘Actionable tactics’
The joint effort between ASCO and ACCC began in July 2020, when the organizations issued a request for ideas seeking novel strategies to improve clinical trial EDI. They applied the responses to the development and pilot testing of a research site self-assessment and implicit bias training program. These programs have been implemented at 75 research sites across the United States. Having completed the pilot testing, the organizations will make the assessment and training available for public access this summer.
“The imperative to make cancer care equitable, driven by innovative cancer research, has been crystallized into two essential and actionable tactics: first, assess and get your house in order to provide cancer clinical trials to all of your patients in your practice or institution,” Oyer said. “Second, recognize your own implicit biases so that we are not excluding people who deserve to be offered and participate in a treatment trial.”
Pierce emphasized the importance of taking action on improving cancer clinical trial EDI, rather than just talking about the problem.
“It’s not enough just to say you’re committed,” she said. “Programs should measure and report the number of people screened and enrolled, the barriers encountered, and the resources used to enroll patients in clinical trials so that they can then identify and mitigate potential issues.”
References:
Oyer RA, et al. J Clin Oncol. 2022:doi:10.1200/JCO.22.00754.
Unger JM, et al. J Natl Cancer Inst. 2021; doi:10.1093/jnci.djaa155.
For more information:
Randall A. Oyer, MD, can be reached at Penn Medicine Lancaster, 2106 Harrisburg Pike, Lancaster, PA 17061; email: randall.oyer@pennmedicine.upenn.edu.
Lori J. Pierce, MD, FASTRO, FASCO, can be reached at Rogel Cancer Center at University of Michigan, 1500 E. Medical Center Drive, Ann Arbor, MI 48109; email: ljpierce@umich.edu.
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