Case Study

No patient recruitment in the 1st year of a Global Clinical Study

Ph2 single arm Breast Cancer

Discovery:

To understand this problem, we called several Principal Investigators Study Coordinators, we identified that the Protocol and Lab Manual have major issues that were impossible to comply with.

Solution:

After a comprehensive review of the protocol, manuals, and project timelines, we proposed clear solutions and amendments to these documents. Following implementation, 20 sites recruited 15 patients within six months, and full recruitment was achieved within 18 months.

Learning lesson and conclusion:

Approx 30% of clinical studies are severely impacted by poor recruitment, risking failure, resource loss, and no return on investment. Our intervention in this Ph2 Global study allow to restart recruitment leading to achievement of objectives with minimal delays. Mauetics will conduct in your future project real-time recruitment reviews, comparing sites, regions, countries to detect potential recruitment barriers early and optimize enrolment performance.