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Strategies to Advance Equity in Cancer Clinical Trials
Carmen E Guerra1,2, Mark E Fleury3, Leslie P Byatt4
1Department of Medicine, Raymond and Ruth Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Abstract:
Cancer clinical trials are critical for testing new treatments, yet less than 5% of patients with cancer enroll in these trials. Minority groups, elderly individuals, and rural populations are particularly underrepresented in cancer treatment trials. Strategies for advancing equity in cancer clinical trials for these populations include (1) optimizing clinical trial matching by broadening eligibility criteria, screening all patients for trial eligibility, expanding the number of trials against which patients are screened, and following up on all patient matches with an enrollment invitation; (2) conducting site self-assessments to identify clinical-, patient-, provider-, and system-level barriers that contribute to low rates of clinical trial screening and enrollment; (3) creating a quality improvement plan that addresses the barriers to enrollment and incorporates the use of tools and strategies such as clinical trial checklists; workforce development and trainings to improve cultural competence and reduce unconscious bias; guides to promote community education, outreach and engagement with cancer clinical trials; screening and accrual logs designed to measure participation by demographics; models of informed consent that improve understanding; clinical trial designs that reduce accessibility barriers; use of cancer clinical trial patient navigators; and programs to eliminate barriers to participation and out-of-pocket expenses; and (4) working with stakeholders to develop both protocols that are inclusive of diverse populations' geographic locations, and strategies to access those trials. These actions will support greater access for populations that have remained underrepresented in cancer clinical trials and thereby increase the generalizability and efficiency of cancer research.
Insights
Improving cancer clinical trial enrollment for underrepresented groups requires optimizing patient matching, assessing site barriers, and implementing quality improvement plans. These strategies aim to increase diversity and enhance cancer research generalizability.
Area of Science:
- Oncology
- Clinical Research
- Health Equity
Background:
- Cancer clinical trials are essential for developing new treatments but suffer from low patient enrollment (<5%).
- Minority groups, elderly individuals, and rural populations are significantly underrepresented in cancer treatment trials, limiting research generalizability.
Purpose of the Study:
- To outline strategies for improving equity and access in cancer clinical trials for underrepresented populations.
- To address barriers contributing to low screening and enrollment rates in cancer clinical trials.
Main Methods:
- Optimizing clinical trial matching processes, including broadening eligibility criteria and ensuring all patients are screened and invited.
- Conducting site self-assessments to identify and address clinical, patient, provider, and system-level barriers.
- Developing quality improvement plans with tools like checklists, cultural competency training, community outreach, improved informed consent, patient navigators, and financial support programs.
Main Results:
- Proposed strategies aim to increase participation from historically underrepresented groups in cancer clinical trials.
- Implementation of these strategies is expected to enhance the generalizability and efficiency of cancer research.
Conclusions:
- Systematic approaches are needed to overcome barriers to cancer clinical trial participation.
- Enhancing diversity in clinical trials is crucial for advancing cancer treatment and research outcomes for all populations.
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