Decentralized methods make financial sense for most Phase II and III clinical trials according to analysis, which suggests spending money on site-free studies generate a seven-fold return on investment.
The analysis – by researchers at the Tufts Center for the Study of Drug Development and clinical trials technology provider Medable – looked at the impact decentralized studies have on eNPV, which is a model of the cash flows for new drug development and commercialization.
According to the authors “The eNPV method accounts for R&D investment cash flows, risks in reaching the marketplace, costs of commercialization, and projected sales.”
And the results suggest that decentralized trials can have a dramatic impact on eNPV, primarily because they are faster than traditional study models.
“Our benchmark data suggest that Phase II and phase III durations can be reduced at least 10%, or 3 months, for each phase. We conservatively assume 10% reductions in the time from the start of one phase to the start of the next phase.”
They add that “The reductions in time bring revenues for drugs that make it to market closer to the start of phase testing, and so increase cash flows after discounting.”
Protocol amendments
The authors also looked at the impact decentralized elements have on protocol amendments, also with an eye on how they affect eNPV. And again, the potential financial benefits are clear.
“Prior Tufts CSDD research indicates that the cost of a substantial protocol amendment is $141,000 for Phase II trials and $535,000 for phase III trials. Tufts CSDD benchmark data indicate that the number of substantive protocol amendments, on average, for Phase II trials is 3.3 for trials with no DCT elements and 2.4 for trials with DCT elements.
“Similarly, Tufts CSDD data indicate that the number of substantive protocol amendments, on average, for Phase III trials is 3.4 for non-DCT trials and 3.2 for DCT trials. Given the reductions in the number of amendments, the cost per amendment, and the assumed number of trials, costs for the base analysis are reduced by $507,600 for Phase II and $321,000 for Phase III because of fewer protocol amendments.”
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