Enrollment Challenge

Pediatric Study

Enrollment Challenge

SPONSOR

A leading ophthalmic healthcare corporation.

PROJECT

A Phase 4 pediatric study of two marketed treatments for pediatric blepharoconjunctivitis, targeting 136 pediatric patients under the age of six. Patient enrollment was three months behind schedule reaching only 50% completion after the first 17 months of enrollment. The Sponsor gave ProTrials seven months to complete enrollment for the study.

CHALLENGE

How do you enroll half the patients in seven months when it took 17 months to enroll the first half? ProTrials determined quickly that study sites were not receiving site-specific recruitment support. Based on our experience, ProTrials immediately made the decision to assign one of our patient recruitment specialists to work closely with the sites to improve recruitment and retention efforts.

Our patient recruitment specialist quickly identified which sites had the greatest potential for enrollment. Focus was placed on this subset of sites and ProTrials rapidly provided them with recruitment ideas, materials and support. In addition to this subset of sites, all other sites were provided with ideas and support that made sense for their practice. ProTrials also assisted sites with developing pediatrician referral networks, organizing informational lunches and dinners, and creating study information flyers.

RESULTS

The study was fully enrolled three months after we initiated our recruitment support – four months ahead of schedule.

SPONSOR FEEDBACK

‘Completion four months ahead of schedule! This has been a great learning experience for all in recruitment initiative implementations.’ -Sponsor Project Manager