Streamlining participant enrolment to address cohort-specific shortfalls

A medical device developer conducting a study to improve their current FDA-cleared ECG monitor application encountered participant enrolment issues. The multi-centre, open label, non-randomized, single blind study involved over 1,500 participants across 10 sites for a duration of 10 months. The study aimed to expand the beats per minute range for atrial fibrillation rhythm, developing a new high heart rate rhythm for sinus rhythm and validate the fidelity of the displayed ECG signal is clinically acceptable for use by healthcare professionals. Participant enrolment occurred in specific regions of the US in three different phases stratified by 3 sub-cohorts per phase of enrolment based on cardiac rhythm and multiple demographic requirements.

Due to demographic and regional variations there were enrolment challenges within some participant cohorts such as BMI under 20, Fitzpatrick scales and younger participants. These cohorts were added to the study protocol after site selection had occurred, where these challenges are typically addressed. Because of this, site enrolment projections did not take these cohort-specific enrolment projections into account. The sponsor asked ICON to develop a plan to address these enrolment issues.

Collaboration and communication were key to overcoming the initial enrolment challenges. ICON worked closely with the sponsor team through routine frequent calls, feedback and approval. It was agreed to expand the study to sites in different regions that supported specific demographics, and the protocol exclusion criteria were relaxed to enrol more participants. ICON held frequent meetings with all sites to discuss trends and strategise recruitment approaches to meet study timelines and goals. A communications campaign was put in place to reach physicians who could refer patients who met the criteria, flyers were posted to local gyms and colleges, and social media advertising was rolled out. Electronic medical records were used to pre-screen and re-screen potential participants that may meet the revised inclusion/exclusion criteria. Participants who were unable to drive were offered transportation.

The initial recruitment challenges were overcome and participant enrolment increased by 44% as a result of the sponsor implementing ICON’s suggested strategies to streamline recruitment. The final database lock was achieved on time and on budget.