The Digital Medicine Society (DiMe) and a suite of digital health and pharma players partnered to launch a toolkit aimed at improving diversity, equity and inclusion in clinical trials.
The resources include a guide to each step of a digital clinical trial, shared definitions of terms like “diversity” and “equity,” a list of different digital tools that could be used and the potential benefits and risks, and recommendations on how to effectively use those tools to enroll and retain more trial participants.
“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,” Jennifer Goldsack, CEO of DiMe, said in a statement. “It’s been one year since the FDA issued draft guidance for DEI in clinical trials, and while organizations have hired DEI heads, many lack a team, sufficient budget and clear direction to make a real difference.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.”
The nonprofit worked with the FDA, pharma and biotech companies Janssen, Amgen and GSK, decentralized clinical trial companies Medable and THREAD Research, and other collaborators including TOUCH Black Breast Cancer Alliance and the National Minority Health Association to build the toolkit.
THE LARGER TREND
Lack of diversity in clinical research can have serious effects on excluded groups, potentially exacerbating health disparities and limiting the impact of scientific innovation.
According to a study published in The Lancet Regional Health – Americas that analyzed U.S. clinical trials between 2000 and 2020, only 43% reported any race or ethnicity enrollment data. In trials that did report that information, white participants were overenrolled compared with their representation in the U.S. population.
There are a number of companies touting technology and services for managing decentralized or hybrid clinical trials. Many of them pitch digital research as a way to ensure more people are able to access clinical trials, allowing them to participate closer to home on their schedule.
Late last month, new venture Paradigm launched with a $203 million Series A round. Kroger Health, the healthcare division of the grocery chain, recently announced its own clinical trial site network, the latest retail player like CVS and Walgreens to step into the clinical trials space.
In a statement at the time, Kroger Health president Colleen Lindholz said the company’s role as a grocer “provides us with the unique opportunity to increase accessibility to clinical trial opportunities.”