FDA Guidance on Decentralised Clinical Trials
This draft document was created by the US Food & Drug Administration (FDA). It aims to provide sponsors, investigators, and other stakeholders with recommendations regarding the implementation of decentralised clinical trials (DCTs) for drugs, biological products, and devices.
FDA Guidance on Decentralised Clinical Trials
Purpose
Today, many clinical trials include decentralised elements that enable the conduct of trial-related activities outside of traditional clinical trial sites. For example, laboratory tests are often performed by remote clinical laboratories, Telehealth solutions allow for fewer in-person visits, and digital health technologies enable remote data capture for various types of trial-related data. By enabling remote clinical trial participation, DCTs have the potential to enhance patient convenience, reduce caregiver burden, and facilitate research on rare diseases and remote populations, thereby improving patient engagement, recruitment, and retention of a meaningfully diverse clinical population.
Content
This draft guidance document provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs for drugs, biological products, and devices. In this guidance, a DCT is defined as a clinical trial where some or all trial-related activities occur at locations other than the traditional clinical trial site—thus pertaining to both hybrid and fully DCTs.
Chapters
1. Introduction
2. Background
3. Recommendations for implementing DCTs
- DCT Design
- Remote Clinical Trial Visits and Clinical Trial-Related Activities
- Digital Health Technologies
- Roles and Responsibilities
- Informed Consent and Institutional Review Board Oversight
- Investigational Products in a DCT
- Packaging and Shipping of Investigational Products
- Safety Monitoring Plan
- Software Used in Conducing DCTs
4. Glossary
Important notice: This draft guidance, when finalised, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not legally binding. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page.