By Dr. Pamela Tenaerts, Chief Science Officer, Medable, Inc.
To develop these insights into the business case for DCTs, researchers conducted a data-driven analysis of the value proposition and return on investment for DCTs using an expected net present value (eNPV) model. The benefits from DCT deployment that were measured and applied to the financial modeling were derived from published benchmarks on clinical trial cycle time, cost, and performance in the literature as well as conservative assumptions about the impact of, and the investment required to deploy a DCT. Benefits used in the model include shorter development cycle times, lower clinical trial screen failure rates, and fewer protocol amendments.
To calculate eNPV, researchers used data collected from previous trials to assume a dollar amount associated with each of the three factors described above to determine the net benefit of a DCT platform compared to a traditional trial framework. Because many Phase II and III clinical trials do not result in regulatory approval of an investigational medical product or drug, calculating the eNPV is a dependable way to estimate potential return on investment, as the eNPV analysis combines these risks of failure with actual costs and other drivers of value.