New Resources Remove Obstacles to Deliver DE&I in Digital Clinical Trials

Digital Health Leaders from Across the Industry Create New Resources as Part of a Pre-Competitive Project led by DiMe

BOSTON, Feb. 15, 2023 /PRNewswire/ -- As part of a pre-competitive collaboration with digital health leaders, the Digital Medicine Society (DiMe) launched a suite of new, free resources to advance diversity, equity, and inclusion (DE&I) in digitized clinical trials.

In today's clinical trials, about 80 percent of participants are white, while only 45 percent are women, far from aligned with current census data. Clinical trials conference agendas are replete with panels discussing diversity, equity, and inclusion yet we continue to fail to develop new medical products that meet the needs of all patients, offer opportunities to participate in clinical trials to all people who could benefit, or develop an understanding of the safety and efficacy of new drugs coming to market. Without changes, not only will we continue to reinforce health inequity, but trials will continue to close without meeting enrollment targets, without demonstrating efficacy, and with billions of dollars wasted.

"We actively continue to put people of color, women, poor communities, and other underrepresented populations at risk every single day with our failure to change the way we run clinical trials," said Jennifer Goldsack, DiMe CEO. "It's been one year since the FDA issued draft guidance for DEI in clinical trials, and while organizations have hired DEI heads, many lack a team, sufficient budget, and clear direction to make a real difference.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."

A live launch event is being held Wednesday, February 15 featuring Dr. Robert Califf, Commissioner of the US Food and Drug Administration and other leaders from across healthcare and clinical trials will speak about the current landscape and share how they plan to use DiMe's resources to advance diversity, equity, and inclusion in their clinical research

The resources launched today remove obstacles to assessing, identifying, and implementing digital tools to advance diversity, equity, and inclusion in trial design and conduct. Tools include:

1. Definitions - industry-wide alignment on "diversity," "equity," and "inclusion" in digitized clinical trials, as well as details to guide each step of a digitized clinical trial.
2. Elements of Digital Clinical Trial - an interactive timeline that tells you which digital tools you can use during each stage of a digitized clinical trial, DEI opportunities and risks to consider, and real-life examples of tool usage.
3. Specific Actions Workbook - recommendations on how to use specific digital tools to improve and increase enrollment and retention of diverse participants in digitized clinical trials.

"To achieve equity in healthcare, we must also be inclusive and representative in our clinical research efforts," said Kimberly Barnholt, Senior Director and Evidence Generation Leader, Data-Systems, US Medical Affairs at Genentech. "At Genentech, we are honored to partner with DE&I experts and advocates from across the industry to develop resources that will help us better engage patients from all communities and have immediate impact on increasing diversity in our trials."

In convening this project team DiMe insisted that collaborators represent all industry voices critical to change, including the FDA. TOUCH Black Breast Cancer Alliance, Inlightened, Rubix LS, Lightship, Reveles, Genentech, Althea.ai, American Kidney Fund, Sage Bionetworks, Scripps Research, Medable, Amgen, GSK, National Minority Health Association, Janssen, Acclinate, Savvy Coop, and THREAD Research worked in a pre-competitive space to collaborate and develop these resources.

The project team issued the call to action: what are you doing to increase clinical trial diversity? They are already leading the field, with case studies demonstrating how DiMe resources, digital tools, and a commitment to a clinical trials enterprise that serves all people can effectively deliver diversity, equity, and inclusion in digitized clinical trials. We invite new resource users to join us in sharing the ways you are delivering DE&I in clinical trials through DiMe's "Resources in Action" case study hub.

About the Digital Medicine Society: DiMe is a global non-profit and the professional home for all members of the digital medicine community. Together, we tackle the toughest digital medicine challenges, develop clinical-quality resources on a technology timeline, and deliver these actionable resources to the field via open-source channels and educational programs.

Media Contact: Carla English, [email protected]

SOURCE Digital Medicine Society (DiMe)