Drug industry sponsors are starting to see return on investment in decentralized trials (DCTs) according to new analysis by Tufts.
Ken Getz, deputy director of the Tufts Center for the Study of Drug Development, spoke about decentralized trials at DIA this month, explaining that COVID-19 was the catalyst that saw many CROs and sponsors opt for remote study models.
“The adoption of decentralized clinical trial technologies was really accelerated by the pandemic,” Getz said, citing a recent Tufts study showing use of decentralized study tech – remote monitoring, eConsent, home delivery – has increased markedly since 2020.
And now companies are beginning to assess the economic impacts of investing in decentralized trial technologies Getz said, explaining that “We see a number of organizations that are now have some familiarity and they're beginning to look for input into their decisions in terms of investment and resource allocation, similar to what they used to get through the typical adoption cycle.
“So we see a number of companies looking for insight into return on investment, when and where, and how to allocate different DCT solutions. We felt that this was the right time to inform one of the primary questions. Can we get a read on the return on investment for DCT deployment?
eNPV modelling
Tufts’ study tried to answer this question using eNPV – expected net present value modelling – which uses data to estimate the success rates for drug R&D.
Getz said, “It's a very, very widely accepted single metric that helps you get a read on the net impact of an investment on financial returns. So it measures the cash flow, both outflow and inflow, and it discounts it back to net present value the value at a single point in time.”
And for DCT the findings of eNPV modelling are positive. For example, Tufts’ modelling suggests that the average duration of Phase II trials carried out with decentralized technologies is 904.6 days versus 1150 for traditional site based studies. At phase III, the averages increase to 1036 days for DCTs versus 1396 for studies in the clinic.
Study close out also happens sooner using decentralized trial tech, 49.4 days vs 67 days at Phase II and 56 days versus 64 days at Phase III, respectively.
And these time savings are only one of the benefits of the DCT approach according to Getz, who said, “the Goodwill that's generated when a patient has a really positive experience, or when you actually are able to demonstrate that you are making a commitment to a patient community. So there's a lot of other intangible or strategic value associated with use of a lot of these approaches as well.”
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