Introduction
As decentralized clinical trials (DCTs) continue to gain traction, managing investigational products (IPs) and ensuring participant safety in this new trial landscape require careful planning. DCTs bring a unique set of challenges, especially when distributing investigational drugs or devices directly to participants or utilizing remote safety monitoring. Here are some key highlights for sponsors and investigators to consider when running a DCT:
1. Drug Shipments to Participants’ Homes
Drugs with strong stability profiles are best suited for direct shipment to participants’ homes. On the other hand, investigational products that require specialized handling or specific storage conditions are generally not ideal for remote distribution. Investigators must ensure participants receive instructions on storing, administering, and returning unused products.
2. Use of Medical Devices in DCTs
When incorporating investigational medical devices into a DCT, sponsors should evaluate the device type and intended use. Devices designed for self-use at home can be appropriate, but high-risk devices that require direct oversight should be administered by qualified personnel. Sponsors can use telehealth for follow-up procedures, provided they do not pose a significant risk to participants.
3. Packaging, Shipping, and Tracking of IPs
Effective distribution of IPs in DCTs requires robust tracking systems and proper documentation. Investigators should oversee the process of shipping IPs and ensure that local healthcare providers (HCPs) or participants receive them in good condition. Sponsors must also outline procedures for handling, packaging, and tracking the distribution of investigational products and the return of unused products.
4. Safety Monitoring in DCTs
A thorough safety monitoring plan is critical in DCTs. This plan should account for the decentralized nature of the trial and ensure that adverse events or medication errors are captured during scheduled visits or reported by local HCPs. Participants need clear instructions on responding to adverse events and seeking local medical assistance when necessary.
5. Electronic Data and Telehealth Visits
Data management in DCTs often involves electronic case report forms (eCRFs) and systems that comply with FDA regulations. Investigators must document real-time video and audio interactions between trial participants and personnel, ensuring security and privacy. Investigators should also allow trial participants to arrange unscheduled telehealth or in-person visits if issues arise.
6. Use of Electronic Systems
Electronic systems play a crucial role in managing various aspects of DCTs, from electronic informed consent to tracking IPs and synchronizing data collected through digital health technologies (DHTs). These systems ensure the reliability and confidentiality of trial data while enhancing communication between trial personnel and participants.
Conclusion
Managing investigational products and ensuring participant safety in DCTs requires a flexible, well-documented approach. By carefully addressing packaging, shipping, device use, and safety monitoring, sponsors can navigate the decentralized environment while maintaining compliance with regulatory standards. Implementing robust electronic systems also enhances the efficiency and security of decentralized trials.
