CASE STUDY: Patient Recruitment and Retention Through a Patient Caregiver Liaison Program
Executive Summary
How Stiris developed a patient-centered support model that improved recruitment, strengthened patient engagement, and achieved 100% retention in a Phase III Myotonic Dystrophy Type 1 (DM1) clinical trial.
Therapeutic Area: Rare Neuromuscular Disease
Indication: Myotonic Dystrophy Type 1 (DM1)
Phase: Phase III
Participant Population: Adolescents
Location: United States and Canada
Challenge: Patients and their caregivers faced increasing participation burden during a complex rare disease clinical trial, putting participant retention and long-term engagement at risk.
Result: Stiris developed its Patient Caregiver Liaison (PCL) program, achieving 100% patient retention among participating patients while improving recruitment and strengthening sponsor relationships with the patient community.
Challenge
Stiris Research was asked to rescue a Phase III clinical trial involving adolescents with Myotonic Dystrophy Type 1 (DM1), running across sites in the United States and Canada.
Recruitment was progressing, but midway through the study, the Sponsor recognized a growing problem: patients and caregivers were facing logistical and emotional burden from ongoing participation.
Beyond retaining enrolled patients, the Sponsor wanted to create a more patient-centered trial experience, one where participants felt heard, supported, and connected throughout their journey. This required a partner who could guide patients through enrollment and continue supporting them afterward, something existing vendors had been unable to offer.
Key challenges included:
- High patient and caregiver burden associated with ongoing participation in a lengthy Phase III study
- Risk of recruitment challenges and patient dropout without consistent, dedicated support
- Limited patient familiarity with the overall clinical trial process
- No dedicated resource to support patients before and after enrollment
- Lack of structured patient and caregiver feedback to inform Sponsor decisions
Solution
Stiris designed and implemented the Patient Caregiver Liaison (PCL) Service, a patient-centered support model combining recruitment guidance with ongoing advocacy throughout the trial.
- Dedicated Patient Caregiver Liaison for Recruitment
Each prospective participant was assigned a Patient Caregiver Liaison who served as a trusted guide through enrollment. The PCL answered questions about the trial and about clinical trial participation in general, addressed concerns, and connected patients directly with participating sites once they were ready to enroll. This personalized support reduced uncertainty and helped patients make informed decisions.
- Seamless Transition to a Patient Advocate
After enrollment, support shifted from the PCL to a Patient Advocate (PA) with experience in the therapeutic area community. The PA remained a trusted resource throughout the study, helping patients and caregivers prepare for visits, resolve logistical concerns, and work through anything that could get in the way of continued participation.
- Continuous Sponsor and Site Feedback
The PCL and PA maintained ongoing communication with study leadership, sharing real-world insight into patient experience, caregiver challenges, and community perspectives. This feedback helped the Sponsor and sites better understand patient needs and make practical adjustments to improve the overall trial experience.
- Patient-Centered Clinical Trial Execution
Stiris worked closely with the Sponsor and sites to identify practical ways to reduce the burden of study participation for patients and caregivers. Even small, patient-centered adjustments, such as changing the timing of blood draws during study visits, made a meaningful difference for caregivers and made participation more manageable for the patient and their families.
Results
- 100% Patient Retention
Of the twenty patients who used the Patient Caregiver Liaison service, every one remained in the clinical trial through completion.
- 100% Extension Study Participation
All eligible patients continued into the Open Label Extension study, a sign of sustained trust and engagement.
- Improved Patient Recruitment
The PCL role also strengthened recruitment, connecting more patients from the Myotonic Dystrophy Type 1 (DM1) community with participating sites. Early education and personalized guidance helped prospective participants better understand what trial participation would involve before enrolling.
- Reduced Patient and Caregiver Burden
Patients and caregivers reported lower stress thanks to continuous access to trusted support throughout the trial journey.
- Stronger Site Relationships
Sites gained clearer insight into patient needs, enabling simple operational adjustments that meaningfully improved the participant experience.
- Enhanced Sponsor Understanding of the Patient Journey
The Sponsor gained a deeper understanding of the challenges patients and caregivers face, helping inform the design of more patient-centered trials in the future.
Sponsor Impact
The Patient Caregiver Liaison program brought recruitment support, caregiver engagement, and ongoing advocacy together into one coordinated service. Beyond the retention numbers, it built trust between patients, sites, and the Sponsor, creating a more collaborative research environment while improving both recruitment and long-term engagement.
Key Takeaways
- Patient-centered support improves clinical trial recruitment and retention
- Dedicated patient and caregiver guidance reduces uncertainty throughout the clinical trial journey
- Caregiver engagement plays a critical role in Myotonic Dystrophy Type 1 (DM1) clinical trials
- Continuous patient feedback strengthens Sponsor decision-making
- Small operational improvements can significantly reduce participation burden
- Long-term patient advocacy builds trust and improves study completion
Retention Shouldn’t Be Left to Chance
Keeping patients informed, supported, and engaged throughout their study journey is critical to successful clinical trial delivery, from enrollment through study completion. Stiris Research’s Patient Caregiver Liaison program combines recruitment support, caregiver engagement, and ongoing advocacy to reduce participation burden, improve retention, and strengthen the relationship between Sponsors, sites, and patient communities.
Connect with Stiris Research to learn how patient-centered clinical trial support can improve recruitment, retention, and participant experience. Contact us: info@stirisresearch.com