The FDA's DCT Draft Guidance: What's Missing?

The Food and Drug Administration (FDA) recently released draft guidance on Decentralized Clinical Trials (DCTs). This guidance is a significant step towards providing a clear framework for implementing DCTs for drugs, biologics, and devices for sponsors and research collaborators. Despite outlining various recommendations across areas such as participant diversity, data management, and coordination of activities, some parts could be expanded on for the industry to take full advantage of the potential of DCTs.

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We reflected on our learnings from delivering  DCTs to highlight three key areas we think can benefit from additional detail: participant engagement, recruitment and retention, and the handling of investigational products. Let’s dive in.

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Participant Engagement

The guidance acknowledges that DCTs can make patient participation easier but could use a deeper dive into participant engagement. Without regular face-to-face interaction with trial personnel, participants may feel less connected to the trial, impacting their engagement and adherence to trial protocols. 

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The guidance could benefit from more explicit recommendations on how sponsors could address these challenges, such as specific ways technology could be used to maintain regular communication with participants (e.g. digital newsletters, shared patient groups, SMS), providing easy-to-understand instructions for trial-related activities, and sending regular reminders for self-administered tests or treatments.

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Our clinical operations team has found success in using such technology, which is integrated into our centralised clinical trial management platform (Citrus), in maximising patient retention in both prevalent and rare disease trials. 

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Patient Recruitment and Retention in DCTs

The FDA's draft guidance on DCTs provides a broad framework for implementing these, but it could go into more detail regarding the specifics of patient recruitment and retention. Traditional patient recruitment and retention through healthcare institutions might not be sufficient in a decentralized study.

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Patient recruitment in DCTs could benefit from a more targeted and personalized approach. Using digital platforms and social media for recruitment could be explored further, as these platforms can quickly reach a broader and more diverse patient population. The guidance could also provide more explicit recommendations on the ethical and practical use of such platforms for patient recruitment. 

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As for retention, employing regular virtual check-ins, using mobile health apps for reminders and motivation, and personalizing patient support could go a long way in decreasing drop-off rates.

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Handling of Investigational Products

The FDA's draft guidance outlines the direct distribution of investigational products to trial participants in their locations. It provides recommendations on maintaining the physical integrity and stability of the investigational product during shipment, including appropriate packaging materials and methods and clear instructions for handling, storing, and returning unused products.

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However, the guidance could go into more detail about the logistical aspects of this process. For instance, tracking and documenting the distribution of investigational products is a critical aspect that ensures the products reach the intended participants and maintains an accurate record of the distribution process. Sponsors could use digital tracking systems to monitor the distribution of investigational products in real time, providing a transparent and efficient way to manage this process.

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Moreover, the return and disposal of unused products in a decentralized setting is another area that requires careful consideration. Sponsors could implement a structured approach for returning unused products, which could include pre-paid return shipping labels and clear instructions for participants. For the disposal of unused products, sponsors could work with licensed waste management companies to ensure these products are disposed of in accordance with regulatory requirements.

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Conclusion

While the FDA's draft guidance on DCTs is a commendable step forward, some areas require further exploration and clarification. By addressing these, the industry could make progress in ensuring that DCTs are implemented effectively and efficiently, ultimately leading to more inclusive, participant-centric clinical trials.

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If you’re thinking about running a DCT, we’d love to hear from you. Lindus Health has helped companies in the US and Europe run DCTs across a wide range of therapeutic areas, including cardiometabolic, neurological, and dermatological conditions across drug and medical device interventions.

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