Our client had initiated a study in a difficult anti-infective therapy area across 17 sites in the USA
Recruitment had been well below the target of eight patients per month, mainly due to a lack of insight into the therapeutic area and poor management of the study sites. Micron were approached to takeover the running of the study with a view to improving patient recruitment, and our intervention at Month 5 showed immediate results by the next month (shown in the graph). Patient enrollment into the study after Micron’s intervention increased to approximately 14 patients per month, and the cumulative recruitment target was achieved by Month 11.
A review of the study suggested that Micron’s ability to accelerate study recruitment was based on the following factors:
- Knowledge of the disease area
- Rapport with investigators and opinion leaders
- Ability to judge sites’ strengths and weaknesses
- Motivated, experienced site monitors who could problem-solve and adopt hands-on management.