Tips for Successful Patient Engagement in Decentralized Trials
One of the most persistent challenges in clinical research, particularly in long-term studies with multiple visits and follow-ups, is maintaining participant engagement. Sustained engagement is essential for generating reliable, high-quality data and minimizing attrition.
While retention can be challenging in traditional site-based trials, decentralized clinical trials (DCTs) introduce additional complexities. Reduced in-person interaction, reliance on technology, and remote data collection require a more proactive, structured approach to participant support.
Although many retention strategies from centralized trials can be adapted, decentralized models demand intentional design, strong oversight, and thoughtful integration of technology.
Below are key areas sponsors and study teams should prioritize.
Key Areas to Watch For:
1. Remote Compliance Tracking:
Effective remote monitoring tools are foundational in decentralized trials. Investigators and study teams must be able to assess adherence in near real-time rather than waiting for scheduled site visits.
Early visibility into compliance allows teams to:
Identify gaps quickly
Proactively contact participants
Understand barriers to adherence
Provide timely intervention and support
Digital platforms, eDiaries, wearable integrations, and telemedicine visits can significantly enhance oversight when implemented thoughtfully. However, these tools should simplify the participant experience, not add burden.
The goal is early engagement, not reactive correction. Today, various software solutions are available allowing study staff to track participant compliance and progress real time. Telemedicine also serves as a valuable resource for PIs and study teams to offer ongoing support and monitor participant engagement.
2. Educational Resources and Ongoing Support:
Beyond participant reimbursement, sponsors should prioritize providing comprehensive educational resources to both study staff and participants. This includes regularly reiterating the study's importance, highlighting the potential future benefits of the study product, and sharing study progress and milestones met. Newsletters, videos, and animations can effectively explain how the product works in the body and what participants should expect at different phases of the clinical study (e.g., understanding that a benefit may be seen during treatment, but a relapse might be expected during a follow-up period).
3. Regular Study Team Meetings:
Study personnel (e.g., study coordinators) are often the first to recognize participant engagement challenges. Recurrent study team meetings can create an opportunity to:
Identify recurring obstacles
Evaluate which engagement strategies are effective
Adjust processes before issues escalate
A feedback loop between participants, study teams and sponsors strengthens the overall trial infrastructure. This feedback approach ensures that participants facing strategies are continually refined based on real-world insights.
4. Regulatory Oversight and Implementation Timelines:
As decentralized methodologies and AI-enabled tools continue to advance, regulatory expectations evolve accordingly. Regulatory authorities such as the FDA have issued an updated guidance on trials incorporating decentralized elements, reinforcing sponsor responsibilities related to data integrity, participant safety, and oversight (such as the new FDA guidance re: conducting clinical trials with decentralized elements).
Sponsors and clinical researchers must:
Validate digital tools appropriately
Ensure data security and privacy protections
Maintain adequate investigator oversight
Document processes clearly
Additionally, participant-facing materials, new technologies, and protocol modifications often require IRB/Ethics Committee review and approval. Timelines can vary significantly depending on the reviewing body, making early planning essential.
Engagement strategies must be built into the operational roadmap from the outset.
Final Thoughts
By focusing on these key areas and embracing technological advancements while adhering to regulatory requirements can significantly improve participant engagement, ultimately leading to more successful and impactful research outcomes in decentralized clinical trials.
