Fully-Decentralized Clinical Trial

A Fully-Decentralized Clinical Trial is a Decentralized Clinical Trial (DCT) that is entirely conducted through a remote patient monitoring.

• AKA: Virtual Trial.
• Example(s):
  • …
• Counter-Example(s):
  • a Partially Decentralized Clinical Trial,
  • a Centralized CT,
  • a Decentralized Social Network,
  • a Randomized Control Trial (RCT),
  • a Remote Online Clinical Trial.
• See: Telemedicine, Digital Medicine, Telehealth, Remote Monitoring Device, Wearable Medical Device, Randomized Clinical Trial, Decentralized Research, Decentralized Computing, Decentralized Web, Decentralized System, COVID-19.

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References

2021d

• (Henderson, 2021) ⇒ Zach Henderson (2021). “Decentralized Clinical Trials: Surviving & Thriving in the Clinical Research World of COVID-19" In: HIT Consultant.
  • QUOTE: The quality - and efficiency-focused Clinical Trials Transformation Initiative (CTTI), has said that decentralized trials (DCTs) can follow a range of approaches, from fully decentralized trials to partially decentralized or hybrid trials, in which some aspects of a trial are conducted remotely while others are performed in person. CTTI notes that DCTs are trials consisting of any combination of certain core features, including no physical trial sites used in the trial, all visits performed via telemedicine or mobile/local HCPs, and/or data captured remotely through use of mobile technologies.

    While DCTs offer several advantages over traditional in-person randomized, controlled trials (RCTs) and momentum for a shift towards DCTs have been growing gradually for years, the primary driver for moving toward the model prior to the pandemic has been its patient-centered focus. The DCT model is especially valuable for patient enrollment efforts, making clinical trials available to patients at non-investigative sites and even enabling participation from home. This broadens the number and diversity of eligible participants, as trials and their benefits are no longer limited to those living near the key urban centers where RCTs are traditionally based but are also open now to those living remotely or in rural areas.

    With the onset of COVID-19, researchers rapidly recognized that DCTs not only removed the burdens and geographic barriers of in-person trial participation but also offered the social distancing now required for the safety of their patients and trial staff. Suddenly, research companies saw the popularity of DCTs skyrocket, and a vast number of clinical trials have been revived due to the exponential adoption of the DCT model, without which many — if not most — of the impacted trials would still be at a standstill.

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