Strategies to Advance Equity in Cancer Clinical Trials

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.

Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer

“…Moreover, we lacked details that would allow us to assess racial and ethnic differences in the pathway to clinical trial enrollment, which is important for clarifying the required intervention. For example, if racial and ethnic differences in clinical trial recommendations are apparent, technology-based interventions that screen patients and automate trial matching might be warranted . Alternatively, if we were to observe that women from minoritized racial and ethnic groups are more likely to reject clinical trials when offered, this might suggest a need for interventions aimed at the patient and physician levels to increase participation.…”

“…For example, if racial and ethnic differences in clinical trial recommendations are apparent, technology-based interventions that screen patients and automate trial matching might be warranted. 24 Alternatively, if we were to observe that women from minoritized racial and ethnic groups are more likely to reject clinical trials when offered, this might suggest a need for interventions aimed at the patient and physician levels to increase participation. Furthermore, because of missing values of key variables (eg, race and stage) within the NCDB data set, we excluded approximately 45% of the original sample to conduct a complete case analysis.…”

Racial and Ethnic Inequities in US Oncology Clinical Trial Participation From 2017 to 2022

“…Beyond the FDA draft guidance intended for industry sponsors of clinical trials, there is further opportunity to potentially address these and other trial inequities through advances in technology. Digital tools that automate patient screening and trial matching have the ability to more easily evaluate larger patient populations for eligibility in an unbiased manner, potentially reducing the burden on research teams while also expanding enrollment opportunities . Similarly, equitable decentralization of clinical trials may help to reduce financial or transportation barriers to clinical trial participation, as could broadening eligibility criteria to improve trial access for all—although these hypotheses are yet to be proven .…”

Increasing Racial and Ethnic Equity, Diversity, and Inclusion in Cancer Treatment Trials: Evaluation of an ASCO-Association of Community Cancer Centers Site Self-Assessment

“…Several initiatives have developed tools to address aspects of recruiting patients from underrepresented racial/ethnic populations for trials. [10][11][12][13][14][15][16] Such tools are often specific to a therapeutic area or type of research program 17 ; address patient-based barriers only 18 ; and/or are designed to raise awareness and educate patients, providers, and/or communities. 12,[19][20][21][22] To our knowledge, existing initiatives do not provide tools that enable different types of trial sites to evaluate their programs, policies, and procedures for equity, diversity, and inclusion (EDI) and/or assess their performance in EDI participation metrics collection, evaluation, and monitoring along the continuum of clinical trial screening, offering, and enrolling patients on trials.…”