New document includes practical resources to improve diversity and inclusion in clinical research

The COVID-19 pandemic has illuminated social and health inequities and the impact of structural and systemic racism in society. While the lack of diverse representation in clinical trials is well known, comprehensive and practical guidance on how to improve diversity and inclusion in clinical research has been lacking.

To address this gap, the Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women's Hospital and Harvard announces the release of the MRCT Center's Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document.

The comprehensive document includes practical resources and tools and outlines a principled, multi-stakeholder approach to optimizing the inclusion of diverse populations in clinical research.

Clinical research, and the lack of appropriate representation, is an integral component of the problem. Change and corrective action are challenging and will only occur with the commitment of the entire clinical research enterprise,"

Barbara Bierer, MD., Faculty Director, MRCT Center

The guidance document begins with the scientific, ethical, and social arguments for diverse inclusion, as well as its business value.

In the "Case for Diversity in Clinical Research," the authors adopt a broad definition of diversity, including demographic factors (e.g., sex, race, age, genetics), as well as non-demographic factors (e.g., comorbidities, organ dysfunction, concurrent medications, environmental factors, compliance) that may change over time.

"We recognize that the dimensions of diversity to be considered are context-specific, and the approach to and importance of diversity demand a context-specific analysis," said Bierer.

The document identifies a number of barriers to inclusion of diverse populations, and importantly, addresses potential approaches and solutions to increase diversity.

Chapters explore broadening engagement, data standards and analysis, study design and conduct, and the accountability of each stakeholder. Specific recommendations and case examples are provided. The guidance is then followed by practical resources and tools (The Toolkit) to facilitate change.

The Multi-Regional Clinical Trials Center Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document was conceived from the MRCT Center Diversity project, "Diversity, Inclusion and Equity in Clinical Trials," with its mission to clarify the importance of, advance the goals of, and provide practical, applicable ways to improve the diverse representation of participants in clinical research.

As part of this project, a workgroup was created, comprised of a dynamic and diverse group of stakeholders. The goal of the MRCT Center's Diversity workgroup is to clarify the meaning and advance the goals of diverse representation of participants in clinical research.

Over the course of more than two years, it has worked to substantiate and qualify the value of diversity, inclusion, and health equity in clinical research; explore why diverse representation has not increased despite numerous calls to action; identify and analyze barriers that limit diverse participation; and develop guidance materials, tactical strategies, and tools to advance required changes to conceptual, organizational, and operational challenges

"We appreciate that this work is necessary, but not easy, and will take time to achieve meaningful change," said Bierer. "We appreciate that the guidance is a living document, one that will grow as experience and considered analyses inform successful approaches."

Visit the Diversity in Clinical Trials website for more information and to download the MRCT Center's Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document.

The Multi-Regional Clinical Trials Center is a research and policy center associated with two of the world's most respected names in healthcare and academia: Brigham and Women's Hospital and Harvard.

The mission of the MRCT Center is to engage diverse stakeholders to define emerging issues in global clinical trials and to create and implement ethical, actionable, and practical solutions to improve Improve the integrity, safety, and rigor of global clinical trials.

Brigham Health, a global leader in creating a healthier world, consists of Brigham and Women's Hospital, Brigham and Women's Faulkner Hospital, the Brigham and Women's Physicians Organization and many related facilities and programs.

With more than 1,000 inpatient beds, approximately 60,000 inpatient stays and 1.7 million outpatient encounters annually, Brigham Health's 1,200 physicians provide expert care in virtually every medical and surgical specialty to patients locally, regionally and around the world.

An international leader in basic, clinical and translational research, Brigham Health has nearly 5,000 scientists, including physician-investigators, renowned biomedical researchers and faculty supported by over $700 million in funding.

The Brigham's medical preeminence dates back to 1832, and now, with 19,000 employees, that rich history is the foundation for its commitment to research, innovation, and community.

Boston-based Brigham and Women's Hospital is a teaching affiliate of Harvard Medical School and dedicated to educating and training the next generation of health care professionals. For more information, resources, and to follow us on social media, please visit brighamandwomens.org.