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

Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibility, utility, and face validity of a two-part clinical trial site self-assessment to enable diverse types of research sites in the United States to (1) review internal data to assess racial and ethnic disparities in screening and enrollment and (2) review their policies, programs, procedures to identify opportunities and strategies to improve EDI.

Strategies to Advance Equity in Cancer Clinical Trials.

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.

Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement.

A concerted commitment across research stakeholders is necessary to increase equity, diversity, and inclusion (EDI) and address barriers to cancer clinical trial recruitment and participation. Racial and ethnic diversity among trial participants is key to understanding intrinsic and extrinsic factors that may affect patient response to cancer treatments. This ASCO and Association of Community Cancer Centers (ACCC) Research Statement presents specific recommendations and strategies for the research community to improve EDI in cancer clinical trials.

Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement.

Purpose: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments.

Closing the Rural Cancer Care Gap: Three Institutional Approaches.

Patients in rural areas face limited access to medical and oncology providers, long travel times, and low recruitment to clinical trials, all of which affect quality of care and health outcomes. Rural counties also have high rates of cancer-related mortality and other negative treatment outcomes. On April 10, 2019, ASCO hosted Closing the Rural Cancer Care Gap, the second event in its State of Cancer Care in America series.