Alliance aims to drive inclusivity in trials backed by digital devices

Why we need the human element of remote clinical trials

A consortium led by the Digital Medicine Society (DiMe) has been set up to try to end inequities in access to clinical trials, focusing on the increasing number of studies that use digital devices to allow participation.

The organisation has teamed up with drugmakers GlaxoSmithKline and Amgen as well as partners in the clinical research, patient engagement and data analytics sector on a project to develop the principles that can be used to make sure trials are designed from the ground up to allow broad participation.

More and more trials relying on digital technology to recruit patients, monitor their progress, and collect and manage data. That is allowing greater use of virtual, decentralised studies that can free subjects from the disruption of having to travel to clinics, enhance data collection and – potentially at least – increase efficiencies and reduce costs.

There is a parallel concern however that while greater use of technology can help trial investigators cast the net wider for subjects, it may also perpetuate and extend current barriers to participation in clinical trials.

People who may not be tech-savvy due to age or education, or who have limited access to digital infrastructures because they live in remote settings, could end up being excluded. DiMe's consortium intends to develop the "tools and framework" to help study teams ensure that the way their trials incorporate technology is inclusive.

Other efforts to drive greater inclusion in trials are on the go. One of the consortium partners – decentralised trials player Medable – recently set up a new partnership with CVS to allow recruitment of patients from the latter's network of MinuteClinics, operating out of pharmacies across 30 US states.

"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," said Medable's chief scientific officer Pamela Tenaerts.

"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," she added.

It is estimated that less than 4% of Americans participate in clinical studies, while around a third of those that do so drop out before the trial is completed, with the loss of important data.

Four out of five trials run in the US are unable to recruit their target number of patients on schedule, which is exacerbated by dropouts and can add to the cost of running the study. Moreover, the participation in clinical research by people of colour is "alarmingly low," according to DiMe.

Meanwhile, despite their interest in participating, older adults are also categorically excluded due to barriers such as transport and reliance on a caregiver, says the organisation.

"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," according to Jennifer Goldsack, DiMe's chief executive.

"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," she added.

Along with DiMe, the founder members of the project – due to start in earnest next month – are Acclinate, Amgen, GSK, Lightship, Medable, Rubix LS, Sage Bionetworks, Savvy Cooperative, and THREAD Research.

Other potential collaborators are welcome to register their interest here, according to DiMe.