"Click and mortar" opportunities for digitization and consumerism in trials

Rachel L Randell; Christoph P Hornik; Lesley Curtis; Adrian F Hernandez; Tom Denwood; Camille Nebeker; Jeremy Sugarman; Benoit Tyl; Masahiro Murakami; Leslie Oley Wilberforce; Sherry Pagoto; Ola Vedin; Tomas Andersson; Olveen Carrasquillo; Rowena Dolor; Scott H Kollins; Jill Pellegrino; Megan L Ranney

doi:10.1016/j.cct.2023.107304

"Click and mortar" opportunities for digitization and consumerism in trials

Contemp Clin Trials. 2023 Sep:132:107304. doi: 10.1016/j.cct.2023.107304. Epub 2023 Jul 20.

Authors

Rachel L Randell¹, Christoph P Hornik², Lesley Curtis², Adrian F Hernandez², Tom Denwood³, Camille Nebeker⁴, Jeremy Sugarman⁵, Benoit Tyl⁶, Masahiro Murakami⁷, Leslie Oley Wilberforce⁸, Sherry Pagoto⁹, Ola Vedin¹⁰, Tomas Andersson¹¹, Olveen Carrasquillo¹², Rowena Dolor², Scott H Kollins¹³, Jill Pellegrino¹⁴, Megan L Ranney¹⁵

Affiliations

¹ Duke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA. Electronic address: rachel.randell@duke.edu.
² Duke University, School of Medicine, Durham, NC, USA; Duke Clinical Research Institute, Duke University, Durham, NC, USA.
³ Population Health Partners LLPShort Hills, NJ, USA.
⁴ Herbert Wertheim School of Public Health & Human Longevity Science, University of California San Diego, La Jolla, California, USA.
⁵ Berman Institute of Bioethics and Department of Medicine,Johns Hopkins University, Baltimore, MD, USA.
⁶ Bayer Healthcare SAS, La Garenne Colombes, France.
⁷ Eli Lilly & Company, Indianapolis, IN, USA.
⁸ Evidation, San Mateo, CA, USA.
⁹ Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.
¹⁰ Boehringer Ingelheim AB, Sweden.
¹¹ Bio Pharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
¹² Division of General Internal Medicine Co-Director, Miami Clinical & Translational Science Institute (CTSI), University of Miami, Miami, FL, USA.
¹³ Duke University, School of Medicine, Durham, NC, USA; Akili, Inc, Boston, MA, USA.
¹⁴ Real World Evidence, CVS Health, Woonsocket, RI, USA.
¹⁵ School of Public Health, Yale University, New Haven, CT, USA.

Abstract

Background: Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described.

Methods: We assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance.

Results: Digitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A "click and mortar" approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials.

Conclusion: We offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.

Keywords: Consumerism; Decentralized trials; Digital trials.

Abstract

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