How To Reduce Barriers And Improve Trust In Complex Clinical Trials

From the shock of diagnosis to the emotional weight of ongoing care, participants in rare disease clinical trials face a cycle of trauma that shapes decision-making, engagement, and trial retention. Traditional approaches often misinterpret stress responses as disengagement or noncompliance, overlooking the profound psychological toll of chronic illness.

This guide explores how family and patient-centered trial design can transform participation. Key strategies include early, transparent communication to counter diagnostic isolation, emotional check-ins and flexible protocols to reduce overwhelm, and support systems that extend to siblings and care partners. Recognizing the difference between grief and trauma is critical—grief is cyclical, but trauma fundamentally alters how families think and respond. By integrating empathy with operational excellence, sponsors can address hypervigilance, build resilience, and foster long-term trust.