2021 DecentralizedClinicalTrialsTheF

• (Van Norman, 2021) ⇒ Gail A. Van Norman. (2021). “Decentralized Clinical Trials The Future of Medical Product Development?.” In: JACC: Basic to Translational Science - Elsevier Journal, 6(4). doi:10.1016/j.jacbts.2021.01.011.

Subject Headings: Decentralized Clinical Trial.

Cited By

• Google Scholar: ~ 1 Citations, Retrieved: 2021-09-25.

Quotes

Author Keywords

• Blockchain; COVID-19; decentralized clinical trials; drug development; virtual clinical trials

Abstract

The Covid-19 pandemic disrupted many clinical trials that were potentially bringing new therapeutics to market -” an additional untallied cost of the pandemic in lives and quality of life owing to delays in releasing potentially beneficial therapeutics to patients in need. A separate side-effect of the pandemic has been swift adoption of virtual interactions between physicians and patients to provide continuity of care while maintaining social distancing. This comes at a time of rapid advancement of technology permitting those interactions, such as enhanced internet connectivity, electronic health records, real-time video conferencing, smartphone health applications, and remotely connectable health monitoring devices that are becoming both more accurate, practical, and affordable. Interest in [[decentralized clinical trials (DCTs)]] that use “virtual elements" like these has grown in parallel with acceptance of “œvirtual medicine", accelerating shifts in clinical trial design that many feel are long overdue.

DCTs also termed “direct-to-participant trials" or "œvirtual" studies” are characterized by less dependence on traditional research facilities or specialist intermediaries for data collection. DCTs leverage "œvirtual" tools, such as telemedicine, sensory-based technologies, wearable medical devices, home visits, patient-driven virtual health care interfaces, and direct delivery of study drugs and materials to patients'™ homes. In a fully decentralized clinical trial, subject recruitment, delivery and administration of study medication, and acquisition of trial outcomes data all proceed without involving in-person contact between the study team and the patient/subject. Currently, clinical trials for drug approval often already include decentralized elements, and DCTs often incorporate traditional design with decentralization of the patient/subject interactions (Central Illustration).

Central Illustration: Decentralized Clinical Trials. In decentralized clinical trials, patient visits for healthcare provider interaction and laboratory tests are localized in the patient’s community. Medications for the study are provided either directly to the patient or the local healthcare facility. Other interactions, including patient recruitment and monitoring occur via internet interactions, with data secured and maintained virtually.

References

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	Author	volume	Date Value	title	type	journal	titleUrl	doi	note	year
2021 DecentralizedClinicalTrialsTheF	Gail A. Van Norman			Decentralized Clinical Trials The Future of Medical Product Development?∗				10.1016/j.jacbts.2021.01.011