DiMe, partners launch toolkit for DEI in digitised trials

Working with stakeholder partners from across the industry, the Digital Medicine Society (DiMe) has launched a suite of free tools to help enable diversity, equity, and inclusion in clinical trials, especially digitised clinical trials.

The resource kit is the product of a DiMe-led collaboration with 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.

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 “It’s been one year since the FDA issued draft guidance for DEI in clinical trials, and while organisations have hired DEI heads, many lack a team, sufficient budget, and clear direction to make a real difference.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

During a launch event for the resource, which included panel discussions and an appearance by FDA Commissioner Robert Califf, DiMe program director Yashoda Sharma explained that the toolkit is organised in three parts: Assess, Identify, and Implement. The first set of tools is to help organisations understand and internally explain the importance of DEI efforts and discover opportunities to diversify, the second set helps them find the right tools to use, and the third helps them put into practice specific programmes and remedies.

“Digital tools can be applied to every step of the clinical process,” Sharma said. “Our resources will help you identify the best digital tools to address many of these challenges, while also advancing diversity, equity, and inclusion.”

Like DiMe’s other toolkits, this one is available for free on their website.

Califf cautions on challenges that remain

In his brief but substantive remarks during the event, which was moderated by TOUCH CEO Ricki Fairley, Califf raised several interesting points about the work that’s still to be done on clinical trial diversity.

For one, he cautioned against “taking for granted” that technological tools would necessarily improve inequities.

“I would say – left unattended that is, if there's no specific intention and investment – those who are wealthy and highly educated, are going to take advantage of technology, preferentially, and get the most out of it, compared to those who are not wealthy and highly educated,” he said. “Overcoming that, I believe, takes very much a conscious effort and investment to make it work.”

Califf said that, in terms of the traditional diversity measures of sex, race, and ethnicity, evidence suggests that we are making good progress towards representative trials. But those measures aren’t enough.

“There are many other dimensions of diversity that we need to account for,” he said. “Economics, education, and where you live are critical aspects of diversity. And it's very possible to have a study with sex and race and ethnicity diversity that doesn't take into account any of those variables.” Physical variations like height and weight are important considerations as well, he added. “The beauty of digitisation is there's no technical reason we can't take into account the full spectrum.”

But pharma companies and other trial sponsors also need to grapple with the fact that a pursuit of more representative trials may lead to asking for larger samples and more expensive studies.

“If we're thinking about diversity as a factor, we need to really embrace the statistical fact that having a representative sample in a trial that is only sized to get the primary answer doesn't allow us to draw inferences about the subpopulations, because we don't have the statistical power,” he said.

And speaking to the notion that clinical trial participants are sometimes hard to recruit because of lack of trust or education, and to the notion that clinical trials themselves are often the best treatment option for patients, Califf urged the attendees not to lose sight of the fact that clinical trials are still experiments and not without risks to participants.

“I've been someone who believes that we should move the rhetoric from research subject to participant,” he said. “But I don't think we should do that in a way that overlooks that there is risk involved in clinical trials.”

Finally, the United States has hard questions to answer when it comes to putting a global lens on clinical trial diversity because, while US trials might be starting to reflect the US population, the drugs and treatments being tested ultimately get exported around the world. And the world population, especially the population of most of Africa and parts of Asia, is woefully underrepresented in clinical research, Califf said.