FDA Guidance: Diversity Action Plans to Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies

This draft guidance describes the form, content, and manner of these action plans, the applicable medical products, and clinical studies for which an action plan is required, the timing and process for submitting one, and the criteria and process by which FDA will evaluate sponsors’ requests for waivers from the requirement to submit and action plan.

FDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials, Guidance for Industry and Food and Drug Administration Staf

This guidance is to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad.

FDA Guidance: Evaluation and Reporting of Age, Race and Ethnicity-Specific Data in Medical Device Clinical Studies, Guidance for Industry and Food and Drug Administration Staf

The primary intent of the recommendations in this guidance is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups.

FDA Strategies To Increase Clinical Trial Participation Webinar

A webinar from the FDA addressing ways to enhance trial participation.

FDA Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program

The agency is announcing the opportunity for a limited number of sponsors to participate in a pilot program allowing for more frequent communication with FDA staff to provide a mechanism for addressing clinical development issues.

NASEM Report to Congress: Improving Representation in Clinical Trials and Research

This report models the potential economic benefits of full inclusion of a broad demographic group in clinical research and highlights new programs and interventions in medical centers and other clinical settings designed to increase participation.

NIH All of Us Research Program

All of Us is a database that can inform thousands of studies on a variety of health conditions. It is meant to create opportunities to:

1. know the risk factors for certain diseases;
2. figure out which treatments work best for people of different backgrounds;
3. connect people with the right clinical studies for their needs;
4. learn how technologies can help us take steps to be healthier.

National Institute of Minority Health & Disparities (NIMHD) – Diversity In Clinical Trials

Outlines the institute’s strategic goals on enhancing representation in clinical trials.

MRCT Guidance Document on Achieving Diversity, Inclusion, and Equity in Clinical Research

This guidance document aims to clarify the importance of, advance the goals of, and provide practical and actionable ways to improve representation of participants in clinical research.

Just Ask – Equity and Diversity in Clinical Research

This program provides support to research teams and clinical staff to improve enrollment in research.

PCORI: Guide for Researchers: How to Assist Community Partners to Use Digital Technology

This guide can be used broadly by research teams wanting to engage community members and patients who are not familiar with digital technology.

ICH - Guideline on General Considerations for Clinical Trials

Includes guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality

ICMJE – Authorship Guidelines

The International Committee of Medical Journal Editors (ICMJE) recommendations are a set of guidelines produced by the International Committee of Medical Journal Editors for standardizing the ethics, preparation and formatting of manuscripts submitted to biomedical journals for publication. Authorship Guidelines outline specific criteria to be met to qualify for authorship of a medical journal manuscript.