August 2022 — According to a study from Tufts University, a transition from onsite centralized trials to decentralized clinical trials (DCTs) could significantly improve the drug development process, which is known to be incredibly expensive and very risky, with high failure rates. In an article for Clinical Leader outlining the findings of the Tufts study, CL Chief Editor Ed Miseta reported that researchers at The Tufts Center for the Study of Drug Development (CSDD) estimated that the total cost to develop, trial and launch a new approved drug compound is roughly $2.6 billion.
The Tufts research was supported by Medable, and the resulting report was authored by Dr. Pamela Tenaerts, chief science officer for Medable. The report is titled "Financial Modeling from Tufts Center for the Study of Drug Development Demonstrates Substantial Net Benefits to Sponsors Who Use Decentralized Clinical Trials (DCTs) Technology." Miseta explains that the goal of the study was to produce a data-driven analysis of the "value proposition and return on investment for DCTs using an expected net present value (eNPV) model."
The eNPV measurement integrates cost, time, revenue, and risk into a summary metric for decision making that looks at all cash flows, including outflows from expenses and inflows from commercialization revenues. Trial managers can use the eNPV to develop a lifecycle chart that shows the costs and expenses that supported R&D and the revenues from commercialization. Using this model generates data that is risk-adjusted for the probability of success or failure.
Previous studies have shown that 85% of all clinical trials experience some sort of delay, and those delays can cost drug developers between $600,000 and $8 million per day. The Tufts research showed that by using decentralized technologies such as remote and/or wearable devices and mobile apps trials can have shorter development cycle times. Cycle time reductions can translate to more rapid trial completion.
According to Miseta, Tufts found that 80% of respondents who invested in DCT technologies reported time savings during site initiation through activation. Respondents who provided trial subjects with wearable or remote technologies also reported improvements in trial retention. Their screen failure rates in Phase 3 trials decreased by approximately 10%, while dropout rates decreased from 28.6% to 26.1%.
Amendments are often reported as another cause of delays and increased costs. With a decentralized trial, there are fewer research sites and fewer IRBs and, thus, reduced regulatory costs and increased flexibility around protocol changes.
The report summarized in the Clinical Leader article highlights the efficiencies and cost savings delivered by DCT technologies such as remote visits, telehealth, mobile apps, wearable or remote devices, and home or local assessments. Could the deployment of remote specimen collection devices like the Mitra® or hemaPEN® via home microsampling kits further improve decentralized clinical trial savings and boost recruitment and retention rates?
As mentioned in the Tufts report, roughly 85% of people state they are willing to participate in clinical research, but more than 70% of them live more than two hours away from their study site. The burdens of time and travel can discourage many people from enrolling in research trials or from completing them.
This is curated content. To read more details from the Tufts-Medable report, please read the article by Ed Miseta in Clinical Leader. You can also access the news announcement about the report here.
To learn more about how some organizations apply remote specimen collection and microsampling in decentralized clinical trials, read these related articles:
https://www.neoteryx.com/microsampling-blog/how-microsampling-improves-clinical-research