FDA’s New Guidance on Decentralized Clinical Trials
(Thursday, September 19, 2024)
 
Remote or decentralized clinical trials can make the lives of all stakeholders simpler while yielding high-quality data. Most clinical trials these days involve hybrid systems where parts of the traditional clinical trial activities are conducted remotely. The sponsors must understand the FDA’s expectations from such trials. A new FDA Guidance Document released this week helps with that.
 
Hybrid clinical trials with traditional investigators and sites conducting portions of trial-related activities remotely are easier to envision than a fully remote clinical trial. Due to the many limitations of conducting completely remote clinical trials, very few trials are conducted that way. However, hybrid trials help get benefits both from traditional and remote clinical trial systems. There are a few important considerations for remote or hybrid clinical trials. The new FDA guidance document on the topic is an excellent summary of the potential issues and suggested solutions. Below are the 10 primary areas to consider:
 

1. Decentralization: Clinical trials can be decentralized, meaning activities don’t always happen at a central site. Depending on what the trial needs, this could involve telehealth, local HCPs, or digital tools. Training and coordination are important to ensure that everyone follows the same procedures.
2. Telehealth Visits: Sponsors can use telehealth for trial visits instead of in-person visits if there’s no need for direct interaction. It’s important to assess the medical condition of participants to decide if telehealth is suitable. The trial protocol should clearly state when telehealth visits are okay and when in-person visits are necessary.
3. Privacy: Investigators must ensure privacy during telehealth or home visits. If participants live with others, they might need to schedule visits at convenient times or choose private locations outside their homes. Telehealth visits must follow the applicable laws of the states or countries where participants live.
4. In-Person Visits: These can be done at participants' homes or other preferred locations. Sometimes, healthcare providers (HCPs) near the participants can perform tasks like physical exams, but these HCPs must only do what they’re already trained for in their usual practice. They don’t need to know the full details of the trial, and they are not considered trial personnel.
5. Specialized Activities: If a task requires specific knowledge of the trial, like using detailed medical protocols, it must be done by trained trial personnel. Both participants and personnel may need training on how to handle telehealth visits.
6. Record Keeping: Every visit, whether in person or by telehealth, must be recorded, including the date, who conducted it, and any adverse events (health problems) that come up. The trial protocol should explain how to handle adverse events and ensure they are managed properly.
7. Data Collection and Management: The sponsor needs to have a plan for how data from different sources (e.g., labs or local healthcare providers) will be collected and shared. This plan should describe the methods used for collecting data remotely, including telehealth.
8. Safety Monitoring: The sponsor must have a plan to monitor participants' safety, especially since activities are spread across different locations. Local HCPs should report any unusual symptoms or health issues to the investigators.
9. Informed Consent: Participants can give their consent electronically or on paper from remote locations, as long as regulatory rules are followed.
10. Shipping and Managing Medication: Sponsors must ensure that medications are shipped safely, with clear instructions for participants or local HCPs on handling and storing them. There should also be a system to track how unused medications are returned or disposed of.

 
The remote clinical trial activities in a hybrid clinical trial require careful planning to manage visits, data, safety, and compliance with legal requirements. This guidance gives details that should be used to create trial-specific checklists for planning and execution.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

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