. 2024 May 7;9(5):103373. doi: 10.1016/j.esmoop.2024.103373

Table 1.

Guidelines/recommendations by regulatory authorities to promote diversity and inclusion in clinical trials

Guidelines	Month, year	Recommendations
Australia
Australian Clinical Trial Alliance⁵⁶	June 2020	• Community-led engagement and involvement • Embedding learning and building capability to support sustainable CALD inclusion • Strengthening National Clinical Trial System to promote inclusion for CALD people
Canada
Tri-Agency Statement on Equity, Diversity, and Inclusion⁵⁵		• Support equitable access to funding opportunities • Promote the integration of equity, diversity, and inclusion-related considerations in research teams and research design and practices • Collect the data and conduct the analyses needed to include equity, diversity, and inclusion considerations in decision making
Tri-Agency Equity, Diversity, and Inclusion Action Plan for 2018-2025⁵⁷		• Equitable and inclusive access for all members of the research community to granting agency funding opportunities • Equitable participation in the research system
New Frontiers in Research Fund Best Practices in Equity, Diversity, and Inclusion	2020	• Equity in the team composition and recruitment processes • Equal training and development opportunities • Broaden inclusion and equity in research design
Considerations for Inclusion of Women in Clinical Trials and Analysis of Sex Differences⁵⁸	May 2013	• Adequate female participation in clinical trials for therapeutic products • Inclusion of women with child-bearing potential and postmenopausal women in early stages of clinical trial • Inclusion of subjects on concomitant therapies in early phases of clinical development to identify therapeutic product interactions
Europe
EU Clinical Trial Regulation No. 536/2014⁵⁹	January 2022	• Subjects in clinical trials should represent the population groups that are likely to use the medicinal product with the adequate rationale described in the protocol, especially for the exclusion of underrepresented groups • Clinical trial information should include the population of subjects (including information with the actual number of subjects included in the clinical trial in the member state concerned, in the union, and third countries; age group breakdown, gender breakdown)
ICH guideline E8 (R1) on general considerations for clinical studies⁶⁰	April 2022	• Involve participants who are representative of diverse populations in late-phase studies • Expand the study in size and duration, to include more diverse study populations
ICH E6 (R3) Guideline on good clinical practice⁶¹	May 2023	• Use of innovative clinical trial designs and technologies may help include diverse patient populations, as appropriate, and enable wider participation • Highlights the importance of considering patients’ and/or health care providers’ perspectives in clinical trial design
India
The Functioning of the Central Drugs Standard Control Organization⁶²	May 2012	• Conduct trials across the country to cover patients from major ethnic backgrounds • Ensure that the sites selected for clinical trials are able to enroll diverse ethnic groups
Ministry Of Health and Family Welfare (Department of Health and Family Welfare) The Gazette of India, Extraordinary, PART II—Section 3—Sub-section (i) REGD. NO. D. L.-33004/99 New Delhi⁶³	March 2019	• Studies in special populations (geriatric, pediatric/pregnant lactating women) ○ Should be included in meaningful numbers when the disease intended to be treated is characteristically a disease of this subpopulation or the new drug is likely to alter this population’s response
Japan
Basic Principles on Global Clinical Trials⁶⁴	September 2012	• Trials need to be designed and conducted based on prior evaluation of the ethnic differences • Recommends consultation on specific study design and evaluation methods with PMDA in advance while conducting confirmatory trials
UK
NHS Guidance to Increase Diversity in Research Participation⁶⁵	February 2023	• Pre-research planning ○ Learn about the group of interest ○ Recruiting underrepresented groups for research ○ Practical preparation for workshops and interviews • During the sessions: involve and respect differences • Post-research ○ Provide feedback • Build a positive legacy
Guidance from the NIHR INCLUDE project⁶⁶	July 2022	• Provide questions to guide research teams in designing inclusive criteria • Provide questions to guide funders and reviewers in assessing the inclusiveness of research • Provide questions to guide delivery teams in considering how to improve the inclusion of under-served groups
NIHR Toolkit: Increasing Participation of Black Asian and Minority Ethnic Groups in Health and Social Care Research⁶⁷	December 2018	• Consideration of the communities in which the research needs to be conducted • Undertake effective patient and public involvement in research • Conduct effective recruitment in black and Asian minority ethnic communities • Ensure cultural competency in the conduct of the research • Providing effective feedback to research participants • Recognizing the importance of recruiting black and Asian Minority Ethnic Communities in research: preparing a grant application
United States
NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research⁶⁸	November 2017	• Planning, conducting, and reporting analyses for sex/gender and race/ethnicity differences
FDA: Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry⁵⁰	November 2020	• Broadening eligibility criteria to increase diversity in enrollment ○ Inclusive trial practices ○ Using enrichment enrollment strategies, adaptive trial designs • Study design and conduct considerations for improving enrollment ○ Make trial participation effortless ○ Adopt enrollment and retention practices to make the trial decentralized ○ Expand access
Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials⁴³	April 2022	• Race and ethnicity diversity plan • Timelines and process for submitting race and ethnicity diversity plan • Content of the race and ethnicity diversity plan • Specific goals and plans to meet these goals
Decentralized Clinical Trials for Drugs, Biological Products, and Devices⁶⁹	May 2023	• Consideration of remote clinical trial visits • Use of digital health technologies

CALD, culturally and linguistically diverse; EU, European Union; FDA, Food and Drug Administration; ICH, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; INCLUDE, Innovations in Clinical Trial Design and Delivery for the Under-served; NHS, National Health Service; NIH, National Institutes of Health; NIHR, National Institute for Health and Care Research; PMDA, Pharmaceuticals and Medical Devices Agency.