Submitted comments to FDA

August 05, 2021

The comments submitted were in response to draft guidance on enhancing the diversity of clinical trial populations, which had been published by FDA in June, 2019.

Inaugural conference call held with the working group

August 05, 2021

The 50+ member workgroup for this project began regularly meeting in 2018.

Publication of the Achieving Diversity, Inclusion, and Equity in Clinical Research website.

July 09, 2021

Driving Inclusion in Clinical Research webinar series

May 28, 2021

Launch of the second webinar series ‘Driving Inclusion in Clinical Research’ to focus on how to approach and plan for inclusion, implement recommendations, and sustain progress. Registration is open and available online.

Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations

May 28, 2021

In collaboration with FDA, the MRCT Center hosted ‘Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations.’ More than 30 speakers and 250 guests participated in the three day conference, which was recorded and is available online.

Launch of the ‘Leaning-In Webinar Series,’

May 28, 2021

This webinar series focused on practical approaches and shared experiences for improving diversity in clinical research. Seven webinar sessions were held, featuring a diverse group of guest speakers.

FDA hosted public project launch

May 28, 2021

FDA Office of Minority Health and Health Equity hosted the public launch for Achieving Diversity, Inclusion, and Equity in Clinical Research.

MRCT Bioethics Collaborative: Diversity in Clinical Research

May 15, 2017

This work began at an MRCT Center Bioethics Collaborative, a neutral forum during which a number of clinical research stakeholders convened to discuss diversity in clinical trials.

The attendees of that meeting, represented by a multi-stakeholder group of industry, academia, government, and patient advocacy, agreed that the participant population enrolled in a clinical trial ought to be representative of the general population at a minimum and, optimally, of the intended population for the intervention.

If study populations are skewed, if they lack diversity, then the safety and efficacy, effectiveness, and value of medical interventions—the biological heterogeneity of treatment effect— cannot be adequately investigated and understood. Justice issues also influence diversity – or lack thereof – of study populations, with a fundamental unfairness perceived if specific populations are either disproportionately burdened, or unfairly excluded, from study enrollment.

The attendees at that meeting agreed that, despite the understood necessity as a matter of science and ethics, underrepresentation of gender, sex, ethnic, and racial minorities in drug development, and in clinical research more generally, persists.

The Diversity, Inclusion, and Equity in Clinical Research project was established as an output of that meeting. Click here to learn more about our Bioethics Collaborative.