key: cord-1026783-deb9j28x
authors: Van Norman, Gail A.
title: Decentralized Clinical Trials: The Future of Medical Product Development?∗
date: 2021-04-27
journal: JACC Basic Transl Sci
DOI: 10.1016/j.jacbts.2021.01.011
sha: 35345b4c84d40f721605c6ab7194ca5826a1317b
doc_id: 1026783
cord_uid: deb9j28x

[Figure: see text]

With fewer central research sites, DCTs reduce the number of institutional review boards and redundant applications, decreasing costs and site-specific inconsistencies. Fewer sites also means fewer resubmissions to multiple institutional review boards to institute changes, and better ability to pivot and make across-the-board protocol adjustments to meet evolving study parameters. Remote monitoring means fewer individual assessments, reduced variability of reporters, and potentially smaller studies. Remote patient/subject interactions can occur more frequently and at times and locations more convenient for the subject, thereby improving compliance and potentially enhancing both short-and long-term study safety.

Traditional clinical trials rely heavily on trained intermediaries belonging to the study team, e.g., study coordinators, research assistants, and nursing and physician staff, for data collection and compilation. With DCTs, this function becomes partially or fully virtual. A partially virtual intermediary is one that still requires some direct interaction with the patient, but not necessarily an investigator, such as having a patient enter daily details of medication side-effects in a portal of the research platform. An

Van Norman, G.A. J Am Coll Cardiol Basic Trans Science. 2021;6(4):384-7.

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. (1) . Studies that rely on such virtual tools and automation potentially require smaller investigative teams, and lower costs to sponsors, in both training and full-time employees. Fewer inconveniences to patients/subjects due to virtual data acquisition could potentially increase their willingness and ability to participate in a study, resulting in outcomes that better reflect the safety and efficacy behavior of the study drug in a "real world" environment.

Compared with DCTs, a major advantage to centralized studies is comparatively simple drug distribution and management. In centralized studies, drugs are shipped to trial centers that centrally manage and maintain them. DCTs require shipping to multiple coordinating sites, including potentially directly to patient homes.

For this to occur, there must be assurance of drug stability and appropriate storage facilities in the patient's home, as well as measures to prevent unauthorized access, methods to detect tampering, temperature tracking to assure appropriate drug storage, dosing diaries to record administration of the drug, and communication between the storage system and the drug source to provide timely refills and prevent study interruptions. In addition, local laws may need to be addressed that affect state-specific allow- One concept gaining traction in health care data management is "blockchain" technology-a form of decentralized data management. Blockchain, first associated with "bitcoin" commerce, is a decentralized framework for managing databases. In blockchain, 2 or more parties can exchange information without the need of a "trusted" centralized third party (such as a centralized server) to maintain the shared database. Blockchain technology replaces the authority of the "trusted third party" to resolve discrepancies between participating parties with a "consensus" mechanism among parties. The elimination of the centralized third party improves transaction speed, eliminates costs that are generated by the third party, and eliminates a significant single "point of failure" at which transactions can either be interrupted by a system malfunction, or experience malicious interference (i.e., hacking). Blockchain interactions are therefore also potentially more secure than centralized data management. In a health care blockchain, for example, patients would "own" their own data, which would be stored at multiple "nodes" 

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