DiMe Releases Resources Focusing on Diversity in Digital Clinical Trials

Society for Digital MedicineDiMe and a set of digital health and pharmaceutical players have teamed up to launch a toolkit to improve diversity, equity and inclusion in clinical trials.

resources include guidance for each step of a digital clinical trial, general definitions of terms such as diversity and fairness, a list of different digital tools that can be used, as well as potential benefits and risks, and recommendations for effective use. these tools to enroll and retain more trial participants.

“We We actively continue to put people of color, women, poor communities and other underrepresented populations at risk every day because of our failure to change the way clinical trials are conducted,” Jennifer Goldsack, CEO of DiMe, said in a statement. a year since the FDA released draft guidelines for DEI in clinical trials, and while organizations have hired DEI leaders, many lack the team, sufficient budget, and clear leadership to make real progress. The digital tools available to us today can help us stop admiring the problem of non-representative clinical trials and actually solve this problem.”

The nonprofit has worked with the FDA, pharmaceutical and biotech companies Janssen, Amgen and GSK, decentralized clinical trial companies, Medable and THREAD Research, and other partners including the TOUCH Black Breast Cancer Alliance and the National Minority Health Association to develop a toolkit .

BIG TREND

Lack of diversity in clinical trials can have serious implications for excluded groups, potentially exacerbating health inequalities and limiting the impact of scientific innovation.

According to a study published in The Lancet Regional Health – Americas which analyzed US clinical trials between 2000 and 2020, only 43% reported any data on race or ethnicity. In the trials that reported this information, white participants were overrepresented in the US population.

There are a number of companies advertise technologies and services for managing decentralized or hybrid clinical trials. Many of them are promoting digital research as a way to ensure that more people have access to clinical trials, allowing them to participate closer to home on their schedule.

Late last month, Paradigm’s new venture launched from a $203 million Series A round. Kroger Health, the health care arm of the grocery chain, recently announced its own network of clinical trial centers, a new retail player such as CVS and Walgreens to enter the clinical trial space.

In a statement, Kroger Health President Colleen Lindholtz said the company’s role as a grocer “gives us a unique opportunity to increase access to clinical trial opportunities.”