How to plan decentralized clinical trials

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Decentralized clinical trials offer a wide range of benefits for medical device makers and the patients they serve.

With that in mind, the FDA has released draft guidance for decentralized clinical trials to advance medical product development and research.

Decentralized clinical trials use locations other than traditional clinical trial sites for some or all of the trial-related activities. That means patients who might have previously needed to travel to research sites — their doctor’s office, for example, or a university hospital — can instead participate in trials at home or closer to home.

This allows a broader, more diverse representation of the population to take part in experimental medicine, helping to reduce gender, racial or socioeconomic inequality in medical care.

“The FDA has long considered the benefits of decentralized clinical trials. Advan…

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Decentralized clinical trials can have big financial upside, study finds 

Televisit image courtesy of Medable

The use of decentralized clinical trials (DCTs) exploded during the pandemic, but quantifying their financial benefits has been elusive. 

Medable (Palo Alto, California), the maker of a cloud-based DCT platform, has announced that DCTs can accelerate clinical trial timelines and lead to significant cost savings. 

Medable and its research partner, the Tufts Center for the Study of Drug Development (CSDD), found that for Phase 2 studies, a standard DCT deployment yielded a one-to-three month time savings over a traditional Phase 2 study. In addition, a DCT yielded a financial benefit that is up to five times more than the upfront investment. 

Time savings for Phase 3 studies were similar, while the net financial benefit was up to 14 times more than the upfront investment.

To learn more about the recent research, we spoke with Dr. Pamela Tenaerts, chief s…

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Decentralized clinical trials continue to gain ground

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The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients.

And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after shiny objects in many places,” said Dr. Nirav Shah, chief medical officer of Sharecare (Atlanta, Ga.).

The situation is, however, swiftly changing thanks to the pandemic. Some 44% of pharma, biotech and clinical research professionals have already adopted remote patient monitoring (RPM) or plan to do so in the next 12 months, according to a recent survey from VivaLNK (Campbell, Calif.). Almost two-thirds (65%) of survey respondents reported the pandemic was the primary driver of RPM adoption.

Physicians have w…

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