Assessing the Financial Value of Decentralized Clinical Trials

ABSTRACT:

Background

Deployment of remote and virtual clinical trial methods and technologies, referred to collectively as decentralized clinical trials (DCTs), represents a profound shift in clinical trial practice. To our knowledge, a comprehensive assessment of the financial net benefits of DCTs has not been conducted.

Methods

We developed an expected net present value (eNPV) model of the cash flows for new drug development and commercialization to assess the financial impact of DCTs. The measure of DCT value is the increment in eNPV that occurs, on average, when DCT methods are employed in comparison to when they are not. The model is populated with parameter values taken from published studies, Tufts CSDD benchmark data, and Medable Inc. data on DCT projects. We also calculate

SUBMITTER: DiMasi J 

PROVIDER: S-EPMC9473466 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature