FDA encourages decentralized trials with new guidance
BIOMARKER
1. The FDA has issued guidance on decentralized clinical trials (DCTs), emphasizing the need for accurate data collection as information is gathered from patients' homes or local healthcare facilities.
2. The agency encourages DCTs as a means to enhance diversity in clinical research.
3. DCTs may include obtaining lab tests at local facilities or conducting follow-up visits via telemedicine, reducing the burden on patients and making trials more accessible.
4. FDA Commissioner Robert Califf stated that DCTs could improve convenience for trial participants, enhance access to diverse populations, and facilitate research on rare diseases.
5. The FDA believes greater adoption of DCTs can improve drug development in areas of medical need, leading to more treatment options and better patient outcomes.
6. The guidance covers topics such as DCT design, conducting remote clinical trial visits, use of digital health technologies, roles of the sponsor and investigators, and informed consent considerations.
7. For DCT design, the FDA suggests having a physical location to store all clinical trial-related records, even if the trial activities are decentralized.
8. The FDA acknowledges that data variability in DCTs may differ from traditional trials but should not affect the validity of a finding of superiority.
9. Investigators are encouraged to consider telehealth visits and home visits by trial or local healthcare personnel, with research-specific activities performed by qualified trial personnel.
10. The guidance also details the application of digital health technology in data transmission, roles and responsibilities of investigators and sponsors, and the requirement for an institutional review board to oversee the remote informed consent process.