An official website of the United States government 
FDA Rare Disease Day 2024: Clinical Trial Foundations and Future Directions
Starts On:
Wed, 4/24/24: 12:00 AM EDT
Ends On:
Fri, 4/23/27: 11:45 PM EDT
Type:
Enduring Material
Credits:
1.75
Description:
FDA experts discuss the legal frameworks governing the use of investigational drugs, biological products, and devices in FDA-regulated
research and the standards governing the review and marketing authorization of such products. This enduring material addresses how FDA incorporates the patient voice in our regulatory decisions. This enduring material will also discuss innovative methods to increase patient access and participation in clinical studies such as decentralized clinical trials (DCTs) and the importance of developing digital health technologies (DHTs) to facilitate them. In the future, we expect more clinical trials to become decentralized where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants helping to minimize travel burden, improve diversity in study populations, and facilitate research on rare diseases.
research and the standards governing the review and marketing authorization of such products. This enduring material addresses how FDA incorporates the patient voice in our regulatory decisions. This enduring material will also discuss innovative methods to increase patient access and participation in clinical studies such as decentralized clinical trials (DCTs) and the importance of developing digital health technologies (DHTs) to facilitate them. In the future, we expect more clinical trials to become decentralized where some or all of the trial-related activities occur at locations other than traditional clinical trial sites. These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants helping to minimize travel burden, improve diversity in study populations, and facilitate research on rare diseases.
Objectives:
- Describe the legal framework for approving medical products at FDA and the differences between those for drugs and biologics versus devices.
- Define what decentralized clinical trials are and why such trials may improve diversity and inclusivity in clinical trials and improve trial efficiency.
Additional Information:
Review the Activity Announcement for additional details: Announcement Form
U.S. Food and Drug Administration