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. Just two months ago, 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 The Food and Drug Administration (FDA) published a draft guidance calling for improved enrollment of participants from underrepresented populations.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.
HumanFirst helps 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 latest publication in npj Digital Medicine, HumanFirst 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.
HumanFirst is a cloud-based technology company for life sciences. The Atlas platform by HumanFirst provides comprehensive insights on AI-powered biomarkers and COAs, spanning multi-modal technologies, including connected sensor-derived DHTs, questionnaires, blood and fluid markers, and imaging to accelerate drug development.
HumanFirst’s solutions reduce costs and de-risk trial portfolios by:
- Accelerating the time to deploy in a trial by aggregating and curating evidence to enable faster decisions on protocol design
- Increasing likelihood of submission approval with better data and comprehensive evidence and insights
- Prioritizing patient-centered research by helping measure what matters to patients
To date, HumanFirst curates more than 15,000 digital measures and biomarkers captured from more than 3,100 digital health technologies deployed across 1,700 clinical trials. Each measure is associated with robust evidence from 9,000+ peer reviewed publications, research papers and conference abstracts. Customer results with HumanFirst include up to 12 months’ acceleration to trial deployment leading to millions in cost savings.
HumanFirst’s solutions have been used by leading academic medical institutions such as Harvard and Stanford, and by 24 out of 25 of the world’s largest pharmaceutical companies to unlock evidence-based precision measures that bring better treatments to market, faster.
Visit www.gohumanfirst.com to learn how you can Be First with HumanFirst.