Background: In the last few decades developers of new drugs, biologics, and devices have increasingly leveraged digital health technologies (DHTs) to assess clinical trial digital endpoints. To our knowledge, a comprehensive assessment of the financial net benefits of digital endpoints in clinical trials has not been conducted. Data and Methods: We obtained data from the Digital Medicine Society (DiMe) Library of Digital Endpoints and the U.S. clinical trials registry, ClinicalTrials.gov. The benefit metrics are changes in trial phase duration and enrollment associated with the use of digital endpoints. The cost metric was obtained from an industry survey of the costs of including digital endpoints in clinical trials. We developed an expected net present value (eNPV) model of the cash flows for new drug development and commercialization to assess financial value. The value measure is the increment in eNPV that occurs when digital endpoints are employed. We also calculated a return on investment (ROI) as the ratio of the estimated increment in eNPV to the mean digital endpoint implementation cost. Results: For phase 2 trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% to 48% per indication. The net benefits were substantially higher for phase 3 trials, with the increase in eNPV varying from $27 million to $48 million, with ROIs that were four to seven times the investment. Conclusions: The use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs.

JD, ZS, AD, and KG have nothing to disclose. JG and SV are employees of DiMe. TM, UG, LL, CU, DK, LM, and BH are employees of pharmaceutical companies.

This research was supported in part by a grant from Bayer, Johnson & Johnson, MindMed, and Roche to the Tufts Center for the Study of Drug Development

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