> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Decentralized Clinical Trial Comments
- URL: https://www.fdaweb.com/decentralized-clinical-trial-comments/
- Published: 2023-08-02T12:00:00.000Z
- Updated: 2026-09-14T18:47:54.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5155013

The Advanced Medical Technology Association (AdvaMed) says decentralized clinical trials can facilitate diversity in clinical trials. Commenting on an FDA draft guidance on decentralized clinical trials for drugs, biological products, or medical devices, AdvaMed [says](https://www.regulations.gov/comment/FDA-2022-D-2870-0031?ref=fdaweb.com) the document can facilitate recruitment of diverse populations in clinical trials and may help expedite recruitment of human subjects to clinical trials to help accelerate patient access to innovative technologies.

The comment letter also discusses additional steps the federal government can take to facilitate clinical trials, the way that trials conducted during the Covid-19 pandemic can help inform guidance, and a table of specific line-by-line comments.

The Biotechnology Innovation Organization (BIO) [says](https://www.regulations.gov/comment/FDA-2022-D-2870-0026?ref=fdaweb.com) the “implementation of one or more elements of decentralized clinical trials has the potential to improve and expedite enrollment of trials in therapeutic areas with small patient populations; improve trial population diversity to match disease population demographics more closely; mitigate logistical and financial burden for patients and caregivers; improve patient safety by reducing unnecessary exposure to infectious disease, especially for immunocompromised patients; and potentially lower trial costs for sponsors.”

BIO also includes specific comments on local healthcare providers and trial personnel, greater regulatory scrutiny for decentralized clinical trials, telemedicine, oversight and compliance with good clinical practice, global harmonization, remote sample collection, and regulatory engagement. Its letter contains a table with recommended line-by-line edits.

Finally, Pharmaceutical Research and Manufacturers of America (PhRMA) [says](https://www.regulations.gov/comment/FDA-2022-D-2870-0076?ref=fdaweb.com) it supports the agency’s efforts to provide additional details about its expectations for the design and conduct of decentralized clinical trials and agrees that such trials have the potential to reduce the burden on patients, caregivers, and medical providers involved in clinical trials.

The association says patient input should be a key factor for sponsors employing decentralized elements and thus it encourages FDA to allow for flexibility in trial protocol design and implementation to best incorporate patient input.

Specific comments in the response cover decentralized trial design, remote clinical trial visits and clinical trial-related activities, digital health technologies, roles and responsibilities, and investigational products.