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 The Food and Drug Administration (FDA) published a draft guidance calling for improved enrollment of participants from underrepresented populations.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.
Blog authored by Max Gaitan, Outcomes Researcher, ICON. Originally written for HumanFirst, a company acquired by Icon in january 2024.
In this section
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Digital Disruption
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Clinical trial data anonymisation and data sharing
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Clinical Trial Tokenisation
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Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
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Digital disruption in biopharma
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Disruptive Innovation
- Remote Patient Monitoring
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Personalising Digital Health
- Real World Data
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The triad of trust: Navigating real-world healthcare data integration
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Patient Centricity
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Agile Clinical Monitoring
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Capturing the voice of the patient in clinical trials
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Charting the Managed Access Program Landscape
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Developing Nurse-Centric Medical Communications
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Exploring the patient perspective from different angles
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Patient safety and pharmacovigilance
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A guide to safety data migrations
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Taking safety reporting to the next level with automation
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Outsourced Pharmacovigilance Affiliate Solution
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The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
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Sponsor and CRO pharmacovigilance and safety alliances
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Understanding the Periodic Benefit-Risk Evaluation Report
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A guide to safety data migrations
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Patient voice survey
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Patient Voice Survey - Decentralised and Hybrid Trials
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Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
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Using longitudinal qualitative research to capture the patient voice
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Agile Clinical Monitoring
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Regulatory Intelligence
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An innovative approach to rare disease clinical development
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Using innovative tools and lean writing processes to accelerate regulatory document writing
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Current overview of data sharing within clinical trial transparency
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Global Agency Meetings: A collaborative approach to drug development
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Keeping the end in mind: key considerations for creating plain language summaries
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Navigating orphan drug development from early phase to marketing authorisation
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Procedural and regulatory know-how for China biotechs in the EU
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RACE for Children Act
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Early engagement and regulatory considerations for biotech
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Requirements & strategy considerations within clinical trial transparency
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Spotlight on regulatory reforms in China
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Demystifying EU CTR, MDR and IVDR
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Transfer of marketing authorisation
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An innovative approach to rare disease clinical development
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Therapeutics insights
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Glycomics
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Rare and orphan diseases
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Advanced therapies for rare diseases
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Cross-border enrollment of rare disease patients
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Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
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Diversity, equity and inclusion in rare disease clinical trials
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Identify and mitigate risks to rare disease clinical programmes
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Leveraging historical data for use in rare disease trials
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Natural history studies to improve drug development in rare diseases
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Patient Centricity in Orphan Drug Development
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The key to remarkable rare disease registries
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Therapeutic spotlight: Precision medicine considerations in rare diseases
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Advanced therapies for rare diseases
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Transforming Trials
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Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
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Linguistic validation of Clinical Outcomes Assessments
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Best practices to increase engagement with medical and scientific poster content
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Decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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Decentralised and Hybrid clinical trials
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Practical considerations in transitioning to hybrid or decentralised clinical trials
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Navigating the regulatory labyrinth of technology in decentralised clinical trials
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Biopharma perspective: the promise of decentralised models and diversity in clinical trials
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eCOA implementation
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Implications of COVID-19 on statistical design and analyses of clinical studies
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Improving pharma R&D efficiency
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Increasing Complexity and Declining ROI in Drug Development
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Innovation in Clinical Trial Methodologies
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Risk Based Quality Management
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Transforming the R&D Model to Sustain Growth
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Accelerating biotech innovation from discovery to commercialisation
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Value Based Healthcare
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Strategies for commercialising oncology treatments for young adults
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US payers and PROs
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Accelerated early clinical manufacturing
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Cardiovascular Medical Devices
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CMS Part D Price Negotiations: Is your drug on the list?
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COVID-19 navigating global market access
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Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
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Global Outcomes Benchmarking
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Perspectives from US payers
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ICER’s impact on payer decision making
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Making Sense of the Biosimilars Market
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Medical communications in early phase product development
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Navigating the Challenges and Opportunities of Value Based Healthcare
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Payer Reliance on ICER and Perceptions on Value Based Pricing
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Payers Perspectives on Digital Therapeutics
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Precision Medicine
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RWE Generation Cross Sectional Studies and Medical Chart Review
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Survey results: How to engage healthcare decision-makers
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The affordability hurdle for gene therapies
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The Role of ICER as an HTA Organisation
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Strategies for commercialising oncology treatments for young adults
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