Utilising connected sensors to power diverse and equitable clinical trials

Our publication in Nature npj Digital Medicine outlines current evidence and a solution framework for diversity in research using digital health technologies.

Over seven decades ago, Henrietta Lacks was admitted to Johns Hopkins Hospital with cervical cancer. Lacks, a Black woman, had tissue harvested from her without her consent, and those cells have continued multiplying in labs ever since. They’ve formed the basis for over 100,000 studies, allowing researchers to develop vaccines and life-saving treatments.

Biotechnology companies have profited from products derived from Lacks’ cells for years while her family has never been compensated for her contributions. In 2023 , the Lacks’ family and Thermo Fisher Scientific reached a settlement, recognizing this injustice. biomedical research has exploited individuals in racial and ethnic minority populations, as in the case of Henrietta Lacks, and has underrepresented and excluded groups across a range of social determinants of health (SDoH).

Diversity in drug development matters. It matters for patients, and it matters for study sponsors on several fronts:

Biodiversity. Drug safety and efficacy can differ across groups. If a drug is not studied in a diverse cohort, how can we know whether it is safe and effective for the population?
Economics. Pharma spends billions to develop a drug, sells it for a profit, and is turning to digital technologies to increase return on investment. But could every participant in the clinical trials that supported the drug’s development afford it once brought to market?
Digital determinants of health. Clinical trials are increasingly implementing digital technology. Do trials that require participants to bring their own device and have regular internet access result in treatments that work for people without those resources?

In fact, regulators are beginning to recognize this imperative. The Food and Drug Administration (FDA) published a draft guidance calling for improved enrollment of participants from underrepresented populations.

Connected sensor-based digital health technologies (DHTs) hold the potential to increase diversity and lower the barriers for participating in clinical research. For example, remote cardiac monitoring reduces the need for in-person clinical visits that would otherwise strain some patients financially, require them to take time away from work, and impact caregiver duties.

We help clinical trial sponsors enhance diversity in their trials by evaluating the utility and usability of connected sensor-based DHTs in the context of SDoH. If DHTs are not deployed with careful consideration of SDoH experienced by research participants, they could actually introduce new biases or amplify existing inequities in access. Atlas, life science’s first cloud-based platform for precision measures, tracks data on over 9,000 pieces of evidence, enabling insight into study planning considerations related to SDoH.

In our October 2023 publication in npj Digital Medicine, the formerly HumanFirst team collaborated with experts from the University of California San Francisco and Duke University to evaluate whether clinical research studies utilizing DHTs also report on the SDoH experienced by participants. The findings reveal that publications of clinical research studies deploying DHTs underreport on information related to SDoH. Among the publications analyzed, a majority reported the sex of the research participants. But information on other SDoH, like housing status, access to internet, and employment, were reported in less than five percent of the publications. The findings highlight areas in which the industry can make progress on increasing transparency as to whether DHTs are achieving their potential to enhance equity in clinical research.

“Sociodemographic factors often define the lived experiences of an individual. Digital health technologies present an opportunity to capture data that represent diverse lived experiences, and improved reporting in future studies will help ensure safe and effective therapies across the population” says Nathan Coss, co-first author on the publication.

Using existing standards for data interoperability, the paper proposes a publicly available model solution framework for facilitating collection of data representative of SDoH. Finally, it calls on regulators, fundings agencies, and scientific journals to require reporting of this information.

Enabling patient-centered precision measures is a key aim for DHTs, and precision measures can only be truly patient-centered if they are acceptable, accessible, and usable by the wide range of patients representing diverse life experiences. This is a key moment of opportunity for the field to enhance reporting information related to SDoH. We envision rapid progress — catching up and keeping up with the pace of technological advancement — in work toward representing the breadth of SDoH experienced by patients in clinical trials.

Our publication in Nature npj Digital Medicine outlines current evidence and a solution framework for diversity in research using digital health technologies.

Blog authored by Max Gaitan, Outcomes Researcher, ICON. Originally written for HumanFirst, a company acquired by Icon in january 2024.

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