Healthcare Leaders Join Forces to Transform Digital Clinical Trials Through Diversity, Equity and Inclusion

BOSTON, March 10, 2022 /PRNewswire/ -- The Digital Medicine Society (DiMe) announced today a new collaboration with Acclinate, Amgen, GSK, Lightship, Medable, Rubix LS, Sage Bionetworks, Savvy Cooperative, and THREAD Research to drive inclusion in digital clinical trials. The initiative aims to provide the tools and framework necessary to successfully integrate diverse perspectives during the planning process for trials that include a technology device for participation.

Digital capabilities – from social media to the use of new technologies to measure disease outside of the clinic – offer enormous potential to fix the longstanding disparities in participation and access to clinical trials and comprehensive representation of trial findings. However, technology access, literacy, and trust are not universal truths. These technology devices must be deployed intentionally in order to realize their potential and not simply exacerbate existing inequities along the digital divide. DiMe's new initiative will develop a fit-for-purpose framework that clinical study teams can use to ensure that the way their trials incorporate technology is inclusive for all trial participants.

"When we design a clinical trial, our expectation is that anyone is able to participate - regardless of race or ethnicity, whether they can afford the latest technology or whether they have access to the internet. We simply cannot design clinical trials just for the digitally enabled. If we do that, it leaves us with the same research disparities within clinical trials that we've worked so hard to get rid of over the past decade. Now is the time to ensure trial planning is mindful of the potential of technology as a barrier to participation by positioning digital health technologies for greater trust, use, and impact," says Pamela Tenaerts, MD, MBA, Chief Scientific Officer at Medable.

"Clinical trials are a significant part of the process for developing medicines. Yet, for too long, trials have lacked diversity with underrepresentation of certain groups of people across many diseases," said Ponda Motsepe-Ditshego, VP, Global Medical Therapeutic Area Head, and Leader of Amgen's Representation in Clinical Research (RISE) team. "Having the means to engage these populations via new technologies helps us move towards a future where they are no longer underrepresented, understudied, and undertreated."

To date, clinical trials have struggled to recruit participants that are representative of the broader population. In the United States, the participation in clinical research by people of color is alarmingly low, and despite their interest in participating, older adults are also categorically excluded due to barriers such as transport and reliance on a caregiver.

"At Lightship, we are excited to be part of DiMe's mission to produce action orientated tools to tear down the barriers preventing the inclusion of underrepresented patients.  Every day at Lightship we are meeting patients where they are. We are creating access by breaking down geographic barriers with virtual tools, in-home visits from nurses and clinical site staff. Patients now have a choice – they can participate in a clinical trial from the convenience of their own home, a 'third place' or at the research site. These efforts are driving equity in clinical trials because they're fair, flexible, and prioritize patient choice," says Lightship CEO, David MacMurchy.

"There has been a lot of discussion about the promise of digital to drive diversity, equity, and inclusion in clinical trials, yet there has been an equal discussion about disparities increasing across the digital divide," says Jennifer Goldsack, CEO of DiMe. "I'm incredibly proud of our collaborators for joining us as we move this conversation to action. The digitization of clinical trials is not a future possibility, they are a reality today. Our work will help ensure that these digital clinical trials are more diverse, equitable, and inclusive, and that new medical products that are safe, effective, and apply to all patients go to market."

Collaborative partners for this project are still being considered prior to the project launch in April 2022. Please share your interest in participating in these efforts.

About the Digital Medicine Society: The Digital Medicine Society (DiMe) is the professional society serving the digital medicine community, driving scientific progress and broad acceptance of digital medicine to enhance public health. At DiMe, our commitment to fully integrating experts from all of the disciplines comprising digital medicine is unwavering. From regulators to white-hat hackers, ethicists to engineers, and clinicians to citizen scientists, we are proud to welcome all experts committed to ensuring that digital medicine realizes its full potential to improve human health. Join us!

Media Contact: Jamie Gray, [email protected]

SOURCE Digital Medicine Society (DiMe)