Improving compliance in an Alzheimer’s disease decentralised clinical trial (DCT)

ICON supported a pre-clinical Alzheimer’s disease study focused on biomarker and genetic testing, involving 600 participants across the United States. The trial was fully remote, led by two remote principal investigators (PIs), and utilised a digital recruitment strategy. Each participant was expected to complete a significant number of electronic patient-reported outcomes (ePROs) throughout the study (>50/per patient in some cases).

The decentralised nature of the trial presented unique challenges in maintaining participant engagement and ensuring timely ePRO completion. With no physical site visits, the risk of non-compliance and patient drop-out was heightened. Additionally, the complexity of the protocol required proactive monitoring and support to ensure participants remained within the compliance window.

ICON deployed Concierge direct-to-patient services to provide outreach and assistance beginning at the prescreening phase. The team implemented proactive issue resolution strategies to address non-compliant events swiftly. Platform support was provided throughout the study, and Concierge Services collaborated closely with ICON’s Patient Platform, Digital Risk Detection tools, Accellacare Site Network, and Accellacare In-Home Services to ensure a seamless patient experience.

The study achieved exceptional results, including a 95% patient compliance rate with expected ePROs and a remarkably low drop-out rate of just 2.3%. Patient retention reached 97%, and the trial completed enrolment of 690 participants three weeks ahead of schedule. The sponsor’s compliance threshold was exceeded by an average of 25%, demonstrating the effectiveness of ICON’s decentralised trial support model.