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# Decentralized Trials’ Time Has Come: Marks
- URL: https://www.fdaweb.com/decentralized-trials-time-has-come-marks/
- Published: 2024-05-02T12:00:00.000Z
- Updated: 2026-09-14T14:29:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156907

Writing in the open-source *Journal of General Internal Medicine*, CBER director **Peter Marks** and Brown University medical school professor **Eli Adashi** [say](https://link.springer.com/article/10.1007/s11606-024-08780-0?ref=fdaweb.com) that it appears that decentralized clinical trials (DCTs) are “a paradigm whose time has come, especially since by providing more broadly applicable results they may provide important complementary information to randomized clinical trials (RCTs) that may be conducted in the process of product development.” Marks and Adashi review guidances issued by FDA to support DCTs.

“With an eye towards convenience for study participants who might otherwise be required to travel to distant clinical and laboratory resources,” the two write, “DCTs make a special point of enabling the use of local healthcare providers and local clinical laboratory facilities and of telehealth and digital health technologies to remotely acquire data.”

They caution that DCTs are not a panacea to address all the challenges of RCTs, but rather are another tool that may help facilitate the conduct of clinical trials providing data that may be complementary to those obtained in RCTs that more clearly reflect the use of a treatment in clinical practice in the community.

Marks and Adashi suggest that with appropriate planning, one of the most important consequences of adopting DCTs may be the enhancement of the racial and ethnic diversity of clinical trials, which they say is often difficult to attain with centralized RCTs.