Exceeds Sponsor Milestones after a Project Rescue

Background

Stiris Research was brought in to rescue a North American CRPC Phase II clinical trial after a large global CRO was unable to meet recruitment and site start up timelines. Stiris was given a fixed deadline that all 30 sites needed to be initiated and 30 subjects enrolled by December 30. The rescue study was awarded to Stiris the last week of August.

CHALLENGE:  COMPRESSED PATIENT ENROLLMENT TIMELINE 
  • Sponsor needed 30 patients enrolled by December 31, for investors and SAB.
  • Only half the sites had been initiated by the original CRO at the time of rescue
  • Recruitment was originally planned to begin in August but due to the rescue did not start until September 4.
  • Challenging protocol with difficult inclusion and exclusion criteria
Solution:   Stiris relied on our experienced clinical team to meet the deadline
  • The Stiris project team had an average of 15 years’ oncology experience and at the time of the study had successfully rescued over 20 trials from other CRO’s.
  • Due to Stiris’ flexibility to scale up with team members, we implemented our Study Start Up Task Force and initiated the remaining 15 sites in November. The team then shifted priorities to focus on rapid recruitment.
  • In November, Stiris and the Sponsor created a recruitment initiative whereby the Sponsor would support the fight against prostate cancer by donating $100 to the Prostate Cancer Foundation for every new subject enrolled in the month of December
  • Stiris and the Sponsor collaborated on a conference call to launch the initiative with the study coordinators at the start of December.
RESULTS:
  • Working closely with the sites, Stiris met and exceeded the original target, enrolling 32 subjects by December 30.
  • The charity-focused recruitment initiative brought our relationship with sites to another level and rapidly built a foundation of loyalty and trust.
  • $1200 was donated to the Prostate Cancer Foundation in support of the fight against prostate cancer.
  • The Sponsor’s Board of Directors were very pleased the original milestone was met.
  • Stiris was subsequently awarded an extension study to the original phase II and a new Phase III study.