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Editorial
. 2025 Aug 1.
doi: 10.1007/s12325-025-03283-8. Online ahead of print.

Five Data-Informed Principles for Advancing Inclusive Research in Clinical Trials: A Pharma Perspective

Spencer L James #  1 , Shalini Hede #  2 , Altovise T Ewing-Crawford  1 , Ruma Bhagat  1 , Nicole Richie  1 , Mitchell D'Rozario  1 , Pierre Theodore  1 , Bea Lavery  1 , Sarah Bentouati  3 , Assaf P Oron  4 , Catherine W Gillespie  4 , Cleo A Ryals  5 , Megan H Bair-Merritt  6 , Johanna Chesley  6 , Evelyn Jiagge  7 , Bruno Jolain  3
Affiliations
Editorial

Five Data-Informed Principles for Advancing Inclusive Research in Clinical Trials: A Pharma Perspective

Spencer L James et al. Adv Ther. .

Abstract

Advancing inclusive research (AIR) in clinical trials requires frameworks and metrics for assessing real-world data and measuring population science. Because different factors drive health inequities and variables in measuring population science, relying on one metric for measuring progress may have limitations. Five principles (5Ps) are proposed for AIR globally that form the basis for a data-informed framework to measure and systematically define inclusive research to ensure rigor and benchmarking within organizations and across the broader sector. The first principle addresses biological, genetic, and population science considerations and their responsible use as data elements. The second principle pertains to using data to inform global region, country, and site placement, which includes geographical proportionality in trial enrollment, enabled access and commercialization strategies, and representative real-world demographic representation. The third principle is developing a data-informed and user-informed approach to end-to-end inclusive trial design. The fourth principle integrates patient-reported data collection standards and initiatives supporting complete and consistent clinical trial collection. The fifth principle enables trial access by demonstrating trustworthiness, improving patient navigation, and providing assistance programs. These 5Ps can be used as an end-to-end measurable framework using reference metrics, reproducible data, and methodologies for AIR in clinical development.Infographic available for this article.

Keywords: Advancing inclusive research; Clinical trials; Framework; Population science.

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Conflict of interest statement

Declarations. Conflict of Interest: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: Shalini Hede: employee of Roche, Spencer L James: former employee of Roche, Altovise T Ewing-Crawford: nothing to declare, Ruma Bhagat: nothing to declare, Nicole Richie: nothing to declare, Mitchell D’Rozario: owns stock in Roche, Pierre Theodore: employee of Roche/Genentech Inc, and owns stock in Roche, Bea Lavery: employee of Genentech Inc., Sarah Bentouati: nothing to declare, Assaf Oron: nothing to declare, Kate W Gillespie: employee of the University of Washington. No payments were made to myself or my institution for the present manuscript, Cleo A Ryals: employee of Flatiron, a member of the Roche group and owns Roche stock, Megan Bair-Merritt: nothing to declare, Johanna Chesley: nothing to declare, Evelyn Jiagge: received the Genentech Health Equity Innovation Grant and Pfizer Global Medical Grant; has received other grants from Pfizer, Bruno Jolain: employee of and owns stock in Roche. Ethical Approval: This article is based on previously conducted studies and does not contain any new studies with human participants or animals performed by any of the authors.

References

    1. Gopal DP, Chetty U, O’Donnell P, Gajria C, Blackadder-Weinstein J. Implicit bias in healthcare: clinical practice, research and decision making. Future Healthc J. 2021;8(1):40–8.
    1. Reopell L, Nolan TS, Gray DM, et al. Community engagement and clinical trial diversity: navigating barriers and co-designing solutions—a report from the “Health Equity through Diversity” seminar series. PLoS ONE. 2023;18(2):e0281940.
    1. FDA. Collection of race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products guidance for industry. https://www.fda.gov/media/175746/download Accessed 26 Jan 2025.
    1. National Academies of Sciences, Engineering, and Medicine. Using population descriptors in genetics and genomics research. https://nap.nationalacademies.org/catalog/26902/using-population-descrip... Accessed Jan 14, 2025.
    1. Roche. Position on race, ethnicity, and genetic ancestry application and use in clinical trials and product development. https://assets.roche.com/f/176343/x/2d7dff6f77/race-ethnicity-genetic-an... . Accessed 24 Jan 2025.

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