In September 2024, the FDA finalised its guidance on conducting decentralized clinical trials (DCTs) and integrating decentralized elements into traditional trial models.
This new guidance aims to address evolving practices in clinical trials that leverage remote methods, digital health technologies (DHTs), and decentralized service providers. The primary goal? To make trials more accessible, efficient, and patient-centric while ensuring that compliance, data integrity, and quality are not compromised.
If you are yet to read it for yourself you can access the guidance here
As clinical operations managers and quality assurance professionals, this guidance impacts how you plan, execute, and manage trials, especially in terms of risk management, vendor oversight, and service provider integration.
In this blog I have broken down some of the key principles.
1. What Are Decentralized Clinical Trials (DCTs)?
DCTs refer to trials that use remote methods and digital tools to conduct trial-related activities outside traditional trial sites. DCTs often involve telehealth visits, at-home health assessments, and the use of DHTs to collect patient data. The core advantage of DCTs is that they remove physical barriers to participation, making trials more accessible and efficient.
This new FDA guidance highlights that trial-related activities can take place in the patient’s home, through mobile research units, or local healthcare providers. But integrating decentralized elements introduces new challenges, including managing multiple vendors, ensuring data quality, and maintaining regulatory compliance.
2. Key Challenges in DCTs
While DCTs promise to make trials more efficient and patient-friendly, they also introduce complexity in terms of vendor management, data integrity, patient compliance, and regulatory oversight. Below are some of the core challenges identified in the FDA’s final guidance and what you need to consider:
- Risk Management & Data Integrity: Decentralized elements may introduce variability in data collected remotely. As sponsors and clinical operations teams, you’ll need to ensure that data is collected consistently across all locations, whether through telehealth, digital devices, or local healthcare providers. Risk management processes must be adapted to address these new sources of variability.
- Vendor Management & Integration: DCTs often rely on multiple service providers—local healthcare networks, telehealth platforms, and DHT vendors. Ensuring seamless integration between these vendors, maintaining oversight, and ensuring they comply with protocols is critical. The FDA guidance emphasizes that sponsors must take responsibility for coordinating vendor activities, from local healthcare providers to digital health technology vendors.
- Patient Centricity & Compliance: DCTs are designed to be patient-centric by giving patients more options, but this flexibility can also complicate adherence. You need processes in place to ensure patients comply with trial protocols, whether visits are conducted in person, at home, or through telehealth. This means tracking adherence across multiple locations and service providers, a task that may require additional monitoring tools and communication channels.
- Sponsor Oversight: With so many moving parts in a decentralized trial, maintaining sponsor oversight is crucial. The FDA guidance puts the responsibility on sponsors to oversee all trial-related activities, including those performed remotely. This includes ensuring proper communication between vendors, verifying that digital health technologies are validated, and ensuring all data is accurately reported back to the sponsor.
3. The Role of DHTs
Digital health technologies (DHTs) are at the core of decentralized clinical trials. These technologies can include everything from wearable devices that track patient vitals to telehealth platforms that enable remote visits with trial personnel. The FDA’s guidance sets out specific recommendations for selecting and using DHTs:
- Validation & Usability: Sponsors must ensure that any DHT used in a DCT is validated for its intended purpose and is user-friendly for the trial population. You’ll need to consider whether the DHT fits the needs of your specific trial, especially when it comes to collecting high-quality, accurate data remotely.
- Accessibility: Not all patients will have access to or be comfortable with the DHT required for your trial. To ensure inclusivity, sponsors are encouraged to provide the necessary DHT to participants who do not already own the device or to offer technical support where needed.
- Data Flow & Integration: Managing data from DHTs can become complex, particularly when multiple technologies are involved. The guidance suggests creating a clear data management plan that outlines how data from various DHTs will flow into the main trial database. This requires solid integration between service providers and monitoring of data quality throughout the trial.
4. Patient Centricity and Compliance
One of the major benefits of DCTs is that they are more patient-centric. By allowing patients to participate from home or visit local healthcare providers, DCTs reduce the travel burden and make participation more convenient. However, this flexibility can also create challenges around ensuring patient compliance and delivering consistent data.
- Ensuring Patient Compliance: When patients have more options for how they engage with a trial—whether through telehealth, home visits, or local providers—tracking compliance becomes more complex. Sponsors and clinical operations teams must establish robust methods for tracking patient adherence to the trial protocol, regardless of where the trial activities take place.
- Training & Support: Ensuring that patients understand how to use the DHT provided, how to report adverse events, and how to follow trial instructions is key to maintaining compliance. The FDA recommends providing patients with detailed instructions and, if needed, offering training on how to use the telehealth platform or wearable devices.
5. Managing Vendor Networks and Service Providers
DCTs often require collaboration with multiple service providers, including DHT vendors, local healthcare providers, and telehealth platforms. Managing these providers efficiently is crucial for the success of a DCT. The FDA’s guidance places a strong emphasis on vendor oversight:
- Coordinating Multiple Providers: Each vendor in your network needs to understand their role and how their activities integrate with the overall trial. Clear communication, training, and accountability are essential. The guidance stresses that sponsors must take responsibility for coordinating these efforts to avoid gaps in data collection, patient care, or protocol adherence.
- Vendor Qualification & Compliance: Ensuring that all vendors meet the necessary regulatory requirements is a critical part of trial oversight. This means qualifying each vendor according to your trial’s specific needs and ensuring they have the necessary systems in place to comply with both the trial protocol and FDA regulations.
- Data Flow from Vendors: One of the main risks in decentralized trials is ensuring that data collected by various service providers flows back to the sponsor accurately and in real-time. This requires not only a solid data management plan but also clear communication channels between the sponsor, vendors, and any subcontractors.
6. Ensuring Quality, Safety, and Oversight
The FDA’s guidance emphasizes the importance of maintaining high standards of quality, safety, and oversight in DCTs, despite the decentralized nature of these trials. For sponsors and clinical operations teams, this means:
- Risk-Based Monitoring: A risk-based monitoring approach is critical for DCTs, where trial activities may be spread across multiple locations. Sponsors need to have systems in place to identify data anomalies, protocol deviations, or safety concerns as they arise. This may require the use of centralized monitoring tools that allow for real-time oversight of all trial activities.
- Safety Monitoring: One of the challenges in DCTs is managing adverse events or safety concerns when patients are not physically present at a trial site. Sponsors should implement robust safety monitoring protocols, ensuring that patients know how to report adverse events and have access to medical care when needed.
- Oversight of Decentralized Elements: The FDA stresses that sponsors are ultimately responsible for overseeing all trial-related activities, even those conducted by remote personnel or local healthcare providers. Sponsors must ensure that all remote activities comply with the protocol and regulatory requirements.
7. Adapting Your Processes to Meet the Guidance
With the release of this new guidance, sponsors and clinical research teams must adapt their processes to ensure compliance. Below are some key strategies for aligning your trials with the new guidance:
- Develop a Clear Data Management Plan: Include specific protocols for how data from decentralized elements will be captured, transmitted, and stored. Ensure that all vendors understand the data requirements and have the necessary systems in place.
- Invest in Vendor Management Tools: To effectively manage multiple service providers, sponsors should invest in tools that streamline vendor oversight, communication, and performance tracking. This will help ensure consistency and quality across the board.
- Embrace Patient-Centric Design: When designing a DCT, think about how you can make the trial as convenient as possible for patients without compromising on data quality or compliance. Consider offering patients the option to choose between in-person visits, telehealth consultations, or home visits, while ensuring that you have the infrastructure in place to monitor adherence.
- Implement Robust Training Programs: Whether for vendors, local healthcare providers, or patients, training is key to ensuring that everyone involved in the trial understands their role, the protocol requirements, and the technology being used. Detailed training programs can help reduce variability and improve compliance.
Conclusion
The FDA’s finalized guidance on decentralized clinical trials presents both opportunities and challenges for the clinical research sector. While DCTs offer the potential for greater efficiency, broader patient engagement, and improved accessibility, they also introduce complexities around vendor management, data integrity, patient compliance, and regulatory oversight.
By understanding the key requirements laid out in the guidance and adapting your processes accordingly, you can ensure that your decentralized trials are not only compliant but also effective in delivering high-quality, patient-centric outcomes.
At Mayet, we’re here to help you navigate these changes, providing the tools and support you need to manage vendors, streamline processes, and maintain oversight throughout your decentralized clinical trials.
