Resolving patient recruitment issues in a large scale oncology study

A multi-year in vitro diagnostic (IVD) colorectal cancer study struggled with patient enrolment. This large-scale study had more than 180 sites and 28,000 participants. The sponsor sought support from ICON’s Medical Device and Diagnostic Research team to identify the reasons for patient recruitment issues and to implement effective solutions.

The primary challenges were keeping patient recruitment on schedule and maintaining site engagement. The issues manifested due to: 

• Financial burdens on both sites and patients due to inconsistent insurance coverage of colonoscopy procedures.
• Frequent cancellations or delays in follow up appointments impacting patient retention and adherence to protocol requirements
• Difficulty persuading physicians to use a new, disruptive technology for rapid colorectal cancer diagnosis

When ICON began working with the sponsor the causes of the lack of patient enrolment were unclear. The study’s original timeline was extended to allow a thorough investigation followed by correction of the clinical monitoring and patient recruitment efforts. Starting with the sites that were most impacted by recruitment delays, ICON performed a root cause analysis. Using trend extrapolation ICON identified the scope of the impact to communicate with the sponsor and propose solutions to increase patient recruitment. 

Communication with sites was increased and ICON coached site personnel to: 

• Engage with patient follow up
• Investigate and report patient medical history more substantively
• Assist with financial coverage for sites and uninsured enrolled patients
• Discuss site staff resourcing challenges

Adverts were placed strategically, and recruitment agencies and referral networks were leveraged to improve patient recruitment across all sites. 

Enrolment doubled once the issues were identified and resolved. Screen failure rate was nearly eliminated and lost-to-follow-up patients were recovered and occurred less frequently. Establishing a measurable enrolment rate goal per site allowed for accurate forecasting of study enrolment completion. This meant that the remaining study milestones could be strategically aligned with patient enrolment.