Decentralized studies falling short of expected benefits, research finds

Decentralized trials (DCTs) may not accelerate drug research and reduce costs to the extent previously thought, according to a new study, which suggests interest in the approach has declined since the height of the COVID-19 pandemic.

The study, published in Nature Digital Medicine this month, suggests that the increase in decentralized trials seen in the past decade — and surge in use during the pandemic — has not been sustained.

“A slow but steady increasing trend of DCTs was witnessed from 2014 to 2019. Apparently, a significant burst was between 2019 and 2021 with around 50% increase in the decentralized initiations, during the COVID-19 pandemic.

“However, a sharp decrease happened in 2022 both for the total number of DCT studies and its weight among the overall studies, almost dropping back to the DCT numbers prior to the pandemic,” the authors wrote.

In part, the authors attribute the decline to post-pandemic recovery.

“First, subsequent to the pandemic, the impediments to traditional clinical trials no longer existed. The accessibility of medical services for patients has ceased to be a concern. Sponsors are no longer compelled to assume diverse risks in attempting approaches that have not been fully acknowledged.”

The authors also suggest DCT use has fallen because the approach has not generated the expected benefits, citing a widely cited model and a service provider-sponsored report as examples.

“An academically economic model was established indicating that applying DCT methods results in nearly a fivefold return on investment (ROI) in phase II clinical trials, and a thirteenfold ROI in Phase III trials. Additionally, a report published by service provider claimed significant reduction in timeline and patient screen failure rate

“However, the reduction in cost and increase in drug values seem retained on the model level and non-peer-reviewed report, without conceiving real-world evidence. On the opposite side, remote technologies themselves require startup cost and time, which raises the bar for DCT application and may to some extent offset its potential benefits.”

Solutions

Whether the decline in DCT use continues will depend on how much stakeholders can address the hurdles that have stopped them realizing the benefits of the approach, according to the authors.

“DCT may not have really empowered drug R&D as it was expected. Regulators, service providers, sponsors, and the clinical side need to work together to solve the pain points, improve and promote technical solutions, and map out the applicable scenarios of full-mode DCT in order to genuinely bring practical benefits and impetus to drug discovery and development.”

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