Canadian Cancer Clinical Trials Network. Equity, Diversity and Inclusion (EDI) in Clinical Trials - EDI Toolkit: 6-section toolkit & 17-page framework.

• Summary: The Canadian Cancer Clinical Trials Network’s EDI toolkit exists to support sites, research staff, sponsors, and funders in accessing resources focused on improving and sustaining equitable and inclusive best practices for underrepresented populations in clinical trials. The toolkit contains 6 sections: 1. Trial Awareness, 2. Trial Access & Participation, 3. Trial Design, 4. Increasing Diversity of Clinical Research Teams & Inclusive Hiring Practices, 5. Guidelines, Education & Training, 6. Collection of Race, Ethnicity & Social Demographic Data.

NIH Pragmatic Trials Collaboratory - Maximizing Diversity: Lessons From Implementation Trials (July 16, 2021): 19-min webinar (15-slide presentation, slides 29-43)

• Summary: Dr. Amanda Midboe discusses lessons from implementation trials (which are often pragmatic in nature) for maximizing diversity in participant enrolment, with specific recommendations: 1. Identify what diversity means in the specific context of your trial, 2. Leverage administrative data (when possible) to determine where to target efforts to reach diverse individuals, 3. Involve patients and other partners as early as possible and throughout the trial (e.g., via advisory boards and community-based outreach), 4. Tailor outreach materials and adapt for the setting of interest, 5. Tailor engagement efforts.

Zannad F, et al. How to make cardiology clinical trials more inclusive. Nat Med. 2024 30, 2745–2755. (11-page paper)

• Summary: Describes strategies to foster trial representativeness, with proposed actions at the levels of trial funding, design, conduct and dissemination. While this article focuses on the cardiovascular context, many strategies for making trials more inclusive can be applied to other fields (e.g., broad recruitment strategies and site selection criteria that reflect the diversity of patients in the catchment area, limiting unjustified exclusion criteria, and minimizing research burden on participants). Creating culturally appropriate trial materials and engaging diverse people with lived experience in the co-design of specific trial elements are discussed, as well as diversifying the trial team itself.

U.S. Department of Health and Human Services, Food and Drug Administration. (2020). Enhancing the diversity of clinical trial populations: eligibility criteria, enrolment practices, and trial designs. (4-page summary & 21-page guidance document; 14-min podcast)

• Summary: While focused on the United States context, this document provides recommendations around trial enrolment and retention. It discusses inclusive trial practices, trial design and methodological approaches, broadening eligibility criteria in trials using enrichment strategies, making trial participation less burdensome for participants, adopting enrolment and retention practices that enhance inclusiveness, and expanded access.

Kelsey MD, et al. Inclusion and diversity in clinical trials: Actionable steps to drive lasting change. Contemp Clin Trials. 2022 May;116:106740. (5-page paper) * As this is an optional resource, an institutional login (e.g., university or research institute e-mail address) is required to access this material. 

• Summary: Reviews the proceedings of a conference (that took place in April 2021) with representatives from the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), practicing clinical investigators, pharmaceutical and device companies, community-based organizations, data analytics companies, and patient advocacy groups about the current state of diversity in clinical trials and outlines actionable steps for improvement.