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# Benefits/Challenges of Decentralized Trials: Commentary
- URL: https://www.fdaweb.com/benefits-challenges-of-decentralized-trials-commentary/
- Published: 2024-02-02T12:00:00.000Z
- Updated: 2026-09-14T14:22:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156281

A new [commentary](https://link.springer.com/article/10.1007/s43441-023-00612-3?ref=fdaweb.com) in the 2/2 online *Springer Link* by CDER Office of Medical Policy officials **Ryan Robinson** and **Leonard Sacks** outlines the advantages and challenges of conducting decentralized clinical trials (DCTs). FDA defines DCTs as “trials where some or all of the trial-related activities occur at locations other than traditional clinical trial sites,” such as at home or a local healthcare facility.

Allowing trial participants more flexibility can help with enrollments due to more conveniences to participate, the agency acknowledges. “Advances in technology, including sensors, general-purpose computing platforms, and methods for data processing, transmission, and storage have” helped support the decentralization of trials and limit in-person visits, according to the commentary. Participants can also attend scheduled visits virtually through a telehealth network. “In addition, digital health technologies (DHTs), such as wearables to track activity or mobile applications may be used to acquire data remotely from participants,” it says.

Despite the obvious benefits, the commentary also points to several challenges to using DCTs. For example, “coordination of trial activities with individuals and facilities in multiple locations that are not traditional trial sites” will often be required, it says. “Also, sponsors and investigators must ensure supervision of those delegated to perform trial-related activities, such as local HCPs \[health care professionals\] performing physical exams or providing drug infusion services. To manage such challenges, DCTs generally include specific plans to facilitate decentralization of the trial.” Additionally, it notes that a safety monitoring plan should be in place to address and record adverse events.