Journal Article

Assessing the net financial benefits of employing digital endpoints in clinical trials

DiMasi, Joseph A., Metcalfe, Thomas, Karlin, Daniel, Conradi, Ute, Valentine, Sarah, Leyens, Lada, Smith, Zachary, Grewal, Upinder, Goldsack, Jennifer C., Getz, Kenneth A., Maloney, Lesley, Dirks, Abigail, Hartog, Bert

2024

Overview

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. We obtained data from the Digital Medicine Society (DiMe) Library of Digital Endpoints and the US 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. For phase II trials, the increase in eNPV varied from $2.2 million to $3.3 million, with ROIs between 32% and 48% per indication. The net benefits were substantially higher for phase III trials, with the increase in eNPV varying from $27 million to $40 million, with ROIs that were four to six times the investment. The use of digital endpoints in clinical trials can provide substantial extra value to sponsors developing new drugs, with high ROIs.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc,Wiley
• Subject: Biological products / Clinical trials / Clinical Trials as Topic - economics / Clinical Trials, Phase II as Topic - economics / Corporate sponsorship / Cost-Benefit Analysis / Datasets / Digital Technology - economics / Digitization / Drug development / Drug Development - economics / Drugs / Economic justification / Endpoint Determination / Enrollments / Humans / Libraries / Models, Economic / United States / Variables