4.1 Article

Click and mortar opportunities for digitization and consumerism in trials

Journal

CONTEMPORARY CLINICAL TRIALS
Volume 132, Issue -, Pages -

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2023.107304

Keywords

Digital trials; Consumerism; Decentralized trials

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Digitization and consumerism in clinical trials can increase participant volume and recruitment speed, but can also lead to challenges such as retention issues and ethical concerns. A click and mortar approach that combines technology with traditional trial methods may provide a balanced solution to these challenges.
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.

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