The FDA's New Draft Guidance on Decentralized Clinical Trials: What Is It All About?

Decentralized Clinical Trials (DCTs) are a transformative way of conducting clinical trials that leverages technology to enable participants to partake in trials from their homes or other remote locations. DCTs offer a multitude of benefits for sponsors, investigators, and participants, including increased convenience, reduced costs, and improved access to clinical trials.

The FDA has recently released a draft guidance on DCTs that provides recommendations for sponsors who are considering conducting this type of trial. The guidance covers a number of topics, including the design of DCTs, the use of remote monitoring, and the protection of participant safety.

Defining Decentralized Clinical Trials (DCTs)

DCTs are clinical trials that utilize technology to allow participants to partake in trials from their homes or other remote locations. This technology can include electronic health records, telemedicine, and remote patient monitoring. DCTs can be fully decentralized, meaning that all trial-related activities take place at the participant's home or other remote location. Alternatively, DCTs can be partially decentralized, meaning that some trial-related activities take place at a traditional clinical trial site.

The Rationale Behind the FDA's Move Toward Decentralized Clinical Trials

The FDA is moving toward DCTs for a number of reasons. First, DCTs can offer a number of benefits for sponsors, investigators, and participants. For sponsors, DCTs can reduce the cost of clinical trials by reducing the need for travel and lodging for participants. For investigators, DCTs can make it easier to recruit and retain participants. And for participants, DCTs can offer increased convenience and flexibility.

Second, the technology that is used in DCTs is becoming increasingly sophisticated. This technology is making it easier to conduct DCTs that are safe and effective.

Key Recommendations from the FDA on Implementing Decentralized Clinical Trials

The FDA's draft guidance on DCTs provides a number of recommendations for sponsors who are considering conducting this type of trial. These recommendations include:

Designing the trial to ensure that the participants' safety is protected: This includes ensuring that the remote monitoring technology is appropriate for the trial and that the participants have access to the necessary support services.

Using remote monitoring technology that is appropriate for the trial: The FDA recommends using remote monitoring technology that is reliable, secure, and easy to use.

Ensuring that the participants have access to the necessary support services: This includes providing participants with training on how to use the remote monitoring technology and providing them with access to a support team if they have any questions or problems.

Collecting and managing data in a way that ensures the accuracy and integrity of the data: This includes using a data management system that is secure and can track the data accurately.

Potential Impact and Benefits of Decentralized Clinical Trials for the Clinical Research Industry

DCTs have the potential to significantly impact the clinical research industry. They could enhance the efficiency, accessibility, and inclusivity of clinical trials.

1. Enhanced Participant Recruitment and Retention

DCTs can facilitate the participation of individuals who might otherwise be unable to participate due to geographical constraints, mobility issues, or time commitments. By making it more convenient for individuals to participate, DCTs can expand the pool of potential participants, enhance diversity in clinical trials, and improve participant retention rates.

Consider a DCT for a new treatment for arthritis: it could allow participants to engage from home, using remote patient monitoring devices to track their symptoms and progress. This approach would enable people in rural areas or those with travel difficulties to join the trial, broadening access.

2. Increased Trial Efficiency

DCTs can streamline many aspects of the clinical trial process. By leveraging digital technologies, data can be collected and analyzed more efficiently, potentially leading to shorter trial durations and a faster time-to-market for new treatments.

Take the case of a DCT for a new cancer drug: utilizing electronic health records to track patient progress and collect data on treatment side effects can enable researchers to quickly identify any potential safety concerns and make necessary adjustments to the trial protocol.

3. Improved Data Quality

By allowing for continuous remote monitoring and real-world data collection, DCTs can lead to more accurate and robust data. This could enhance our understanding of treatment effects and drug performance in real-world settings.

For example, a DCT for a new Alzheimer's drug could use wearable devices to track patient activity levels and cognitive function. This data could be used to assess the efficacy of the drug in a more realistic setting than a traditional clinical trial.

4. Patient-Centric Approach

DCTs offer a more patient-centric approach to clinical trials. They reduce the burden on participants by minimizing travel and wait times, which could enhance the participant experience and lead to better engagement in the trial process.

In the context of a DCT for a new antibiotic, participants could receive their medication through the mail, simplifying adherence to the treatment schedule and potentially improving overall health outcomes.

5. Cost Reduction

By eliminating the need for physical infrastructure and reducing the reliance on site staff, DCTs can potentially lead to cost savings in the execution of clinical trials.

A DCT for a new diabetes drug, for instance, could utilize telemedicine for remote patient care, broadening the pool of potential participants and saving money on travel and lodging expenses.

6. Greater Flexibility

DCTs provide greater flexibility in trial design and execution, making it possible to adapt to changing circumstances, such as public health emergencies like the COVID-19 pandemic.

For example, a DCT for a new vaccine could be quickly adapted to include new variants of the virus. This would allow researchers to quickly assess the efficacy of the vaccine against new variants and make adjustments to the trial protocol as needed.

Challenges and considerations in implementing DCTs

There are a number of challenges and considerations that need to be addressed in order to successfully implement DCTs. These challenges include:

Ensuring that the technology is reliable and secure. The remote monitoring technology used in DCTs needs to be reliable and secure in order to protect the participants' data.

Developing protocols that are appropriate for DCTs. The protocols for DCTs need to be carefully developed in order to ensure that the trials are safe and effective.

Training participants and investigators on how to use the technology. The participants and investigators need to be trained on how to use the remote monitoring technology in order to ensure that the trials are conducted correctly.

Collecting and managing data in a way that ensures the accuracy and integrity of the data. The data collected in DCTs needs to be collected and managed in a way that ensures the accuracy and integrity of the data.

Perspective from Maxis Clinical Sciences

Maxis Clinical Sciences is a leading provider of clinical research services. We believe that decentralized clinical trials (DCTs) have the potential to revolutionize the way clinical trials are conducted. We are committed to staying at the forefront of this evolution by leveraging our expertise in clinical research and our proficiency in digital technologies to deliver innovative solutions that align with the FDA's guidance on DCTs.

Our services, including management consulting and business process outsourcing, are designed to support the successful implementation of DCTs. We offer comprehensive solutions for managing decentralized trials, from planning and design through the execution and analysis stages.

We use digital technologies to facilitate remote patient monitoring, data collection, and IP management. Our approach ensures regulatory compliance, data integrity, and patient safety, while also enhancing trial efficiency and participant experience.

We are committed to partnering with our clients to leverage DCTs as a tool for enhancing patient outcomes and accelerating drug development. We are also thought leaders in the clinical research industry, and we understand the importance of continuous learning and staying updated with the latest trends. We are dedicated to sharing our insights and expertise with our community, contributing to the broader conversation on DCTs, and playing our part in shaping the future of clinical research.

In short, we are committed to helping our clients use DCTs to improve patient outcomes and accelerate drug development. We believe that DCTs are the future of clinical research, and we are excited to be a part of this transformation.

Conclusion

The potential benefits of DCTs are significant, but their successful implementation requires careful planning and management to address challenges related to data security, participant privacy, regulatory compliance, and logistical complexities.

Despite these challenges, DCTs have the potential to revolutionize the clinical research landscape and make it possible to bring new treatments to patients faster and more efficiently.

Source: U.S. Food and Drug Administration (2023). Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry. Retrieved from: Decentralized Clinical Trials for Drugs, Biological Products, and Devices