There was a need to address and reverse negative perceptions surrounding the study and the intervention, a medical device. The sponsor required a significant improvement in recruitment of the Phase 2 hypertension study that had fallen significantly behind with patient screening and enrollment.

It was critical to identify the root cause of recruitment delays and address them with tailored solutions. AXON used its TrialDiagnostic™ assessment process, which included online surveys among site staff, in-depth one-to-one interviews with selected site and sponsor staff, as well as a critical review of the patient recruitment program (i.e. materials, referral, or other site support programs). This comprehensive review provided an understanding of the real barriers and challenges to recruitment and also identified tailored solutions that may have the greatest impact on recruitment.

The findings and tailored recommendations included:

  • Findings:
    • Mitigation plans were too complicated and required too much site staff time and effort
    • The pressures to recruit more patients had a negative effect on the site staff and sponsor relationship
    • Site staff were not as committed to the study because they were unclear of the potential long-term benefits of the intervention
  • Recommendations:
    • Communication plan
    • Recruitment Booster Meetings for sponsor team and global site staff
    • Feature newsletter
    • Global WebEx for site staff

Significant impact was made: patient screening increased by 400% following the first set of Booster Meetings in 2016, together with the launch of new recruitment tools and initiatives. The site staff found the tools and initiatives helpful, yielding average participant ratings of 4.8/5 for overall quality.