Decentralized Clinical Trials can lead to Robust Return on Investment for Pharmaceutical Sponsors

Researchers affiliated with Tufts Center for the Study of Drug Development, Tufts University established an expected net present value (eNPV) model of the cash flows for new drug development and commercialization to assess the financial impact of decentralized clinical trials (DCTs). The findings support a measure of DCT value as 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 derived from published studies, Tufts CSDD benchmark data, and Medable Inc. data on DCT projects. Medable is a Silicon Valley-based venture developing a DCT platform profiled in the past by TrialSite. The study authors calculated the return on investment (ROI) in DCTs as the ratio of the increment in eNPV to the DCT implementation cost. Published in Therapeutic Innovation & Regulatory Science, the authors find DCTs can provide substantial extra value to pharmaceutical sponsors, associated with high returns to investment in these technologies.  

The authors acknowledge the need for more research to help pharmaceutical sponsors to expand the data to larger datasets plus additional aspects of clinical trial operations not currently evaluated.