Expert Insights On Decentralized Trials
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Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance
4/16/2025
In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.
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Japan's Adoption Of DCTs Is Slow But Steady
4/16/2025
While global momentum for DCTs accelerates, Japanese healthcare institutions face unique structural and operational hurdles to implement remote and digital trial activities.
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Insights From A Digital Health Intervention Trial For Heart Failure
3/18/2025
University of Twente’s Mark Schuuring, MD, Ph.D. explores how digital health tools can successfully support heart failure interventions, despite hesitancy from providers and skepticism about the interest and abilities of a more senior patient population.
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Social Media And A Site-Less Model Led This Trial To Pandemic-Era Success
3/10/2025
Genescopy's Chief Science and Medical Officer Erica Barnell, MD, Ph.D. explains how social media recruiting and a site-less trial design helped the company's CRC-PREVENT Phase 3 trial succeed.
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In Clinical Research, Every Day Is Groundhog Day
1/30/2025
Rather than proffer some New Year's predictions, Paul Ivsin looks at clinical research through the lens of Groundhog Day and the tradition of reinventing the same thing over and over again.
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How AI Will Transform Health Equity In Clinical Trials In 2025
12/23/2024
Click Therapeutics' CMO/CSO Shaheen Lakhan, MD, Ph.D., FAAN explains how the shift toward AI is the first step in addressing diversity in clinical trials.
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Where Do We Stand With DCTs Heading Into 2025?
12/9/2024
Clinical Leader asked familiar voices and new faces alike: “What’s left to say, to understand, or to do with DCTs (or elements thereof) in 2025?”
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What's Trending In Medical Devices And Diagnostics For 2025?
12/4/2024
Four program directors from the Medical Device Innovation Consortium (MDIC) share their predictions on the trends that will drive innovation and reshape clinical research in 2025.
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Semantics Matter: DCTs And An Industry Decentralized
6/4/2024
Has the term "DCT" fallen out of favor? And if it has — especially among sites — what should take its place? Daniel J. Fox, MPH, Ph.D., clinical site advocate and entrepreneur, advocates for a more accurate and equitable moniker: DCV.
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Will Today's Clinical Trial Trends Become Tomorrow's Routine?
4/23/2024
Clinical trial trends can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in therapeutic areas. Will these trends hold steady as 2024 unfolds?