Proactive patient retention strategy in a GLP-1 RA trial

ICON supported a cardiovascular outcome trial for a GLP-1 receptor agonist, enrolling more than 9,900 patients with type 2 diabetes. The treatment phase of the study spanned approximately seven years from the first patient randomised to the last patient visit. Retaining patients for this length of time required proactive measures from study start to study completion to ensure data integrity and the success of the trial.

ICON proactively implemented a tri-part approach to maximise patient retention at study initiation consisting of:

1. Site outreach and patient engagement;
2. Real-time patient tracking and risk classification; and
3. Systematic mitigation strategy

Site and patient-specific retention strategies were key measures to ensure the selection of experienced sites, long-term engagement of patients and dynamic site response to retention challenges.

Risk-based monitoring was used to trigger additional monitoring of sites identified as meeting predefined retention risk indicators. A dedicated retention team, working in collaboration with a clinical operational team was employed to prevent, detect and correct patient retention issues in conjunction with monitors and sites throughout the study. Through a systematic mitigation process flow and intervention pathway, patient adherence to the study drug and regular study contacts were achieved at maximum potential. Proactive retention strategies included patient education on the investigational product, and proactive provisions for investigational product restart after temporary discontinuation.

Through the use of a multi-pronged proactive retention strategy, less than 1% of participants were at risk for becoming lost to follow-up at the commencement of the final study visits. At study completion, nearly seven years from the first randomised patient, greater than 97% of patients completed the trial.