Goal:
3
Enrollment period:
2 months
Total enrolled: 3
Challenges:
This study had several notable challenges. The exclusion criteria were extensive and ruled out most applicants. Half of the subjects we screened were excluded during the screening window due to laboratory and/or skin test results. Lastly, the visit schedule proved to be the biggest challenge as visits were frequent, long, and included invasive treatments. The enrollment period coincided with the holidays which added another layer of difficulty with managing schedules.
Resolution:
Our site was extremely proactive in identifying protocol-related challenges early on. Pre-screening activities began several months before enrollment. Site staff carefully mapped out study schedules to align with both provider availability and protocol requirements, and subjects were presented with scheduling options to choose from. Through early planning and clear communication among the CRA, study coordinators, and patients, our site successfully met enrollment goals despite the study’s complexity and timing constraints.
