The Digital Medicine Society (DiMe), a non-profit organization, partnered with a number of organizations to release the material, including the US Food and Drug Administration (FDA), GSK, Janssen, and Medable, among others.
The tools released as part of the initiative include ‘Definitions’, ‘Elements of Digital Clinical Trials’, and ‘Specific Actions Workbook’, which DiMe has made available on its website.
According to the organization, Definitions encourages industry-wide alignment on ‘diversity’, ‘equity’, and ‘inclusion’ in digitized clinical trials, as well as detail to guide each step of a digitized clinical trial; Elements of Digital Clinical Trial is an interactive timeline that informs the user of which tools can be used during each stage of a digitized clinical trial; and Specific Actions Workbook recommends how to use specific digital tools to improve and increase enrollment and retention of diverse participants.
DiMe stated that making the tools available is part of its effort to actively aid the industry to advance diversity, equity, and inclusion (DE&I) in digitized clinical trials. The organization outlined that currently US clinical trials are composed of approximately 80% white participants, while only 45% are women.
The organization added that the tools launched will remove obstacles to assessing, identifying, and implementing digital tools to advance DE&I in trials. Without changes to the current system of operation, clinical trials will continue to reinforce health inequity and struggle to meet recruitment targets, DiMe outlined.
Jennifer Goldsack, DiMe CEO, said, “It's been one year since the FDA issued draft guidance for DEI in clinical trials, and while organizations have hired DEI heads, many lack a team, sufficient budget, and clear direction to make a real difference. The digital tools available to us today can position us to stop admiring the problem of non-representative clinical trials and actually address the problem. To really move the needle, we need to stop making excuses and these new resources help us do just that.”
The draft guidance was published in April 2022, wherein the FDA recommended that sponsors of medical products develop and submit a Race and Ethnic Diversity Plan to the agency early in clinical development, based on a framework outlined in the guidance.
To support the agency’s efforts, the Office of Minority Health and Health Equity created the Diversity in Clinical Trials Initiative. The project includes an ongoing public education and outreach campaign to address some of the barriers preventing diverse groups from participating in clinical trials.
