Case Study

Objectives

• Micron was asked to take on a trial in which recruitment rates (16 patients) had not met the target (43 patients) at Month 5.
• The client had undertaken a clinical trial in a difficult anti-infective therapy area across 17 sites in the USA.
• The existing CRO had struggled with challenges in the therapy area and site management.

Contribution

• Prior to Micron’s involvement, recruitment was <5 patients/month, well below the target of 8 patients/month.
• Within the first month of Micron starting the study, monthly patient recruitment attained the target.
• Subsequent months saw recruitment rates above the monthly target rate.
• Consequently, the full complement of patient recruitment was achieved on schedule.

Conclusion

Following a review of the study, Micron’s positive impact was attributed to therapy area knowledge and re-energised relationships with investigators. This allowed a more informed evaluation of sites’ strengths and weaknesses, so our experienced site monitors could address problems, resolve barriers to patient recruitment with sites and accelerating the overall rate of recruitment.