The TMF is the official record of the clinical study for Regulatory Authorities, be it…
A biotech sponsor in the United States had targeted July 2015 for completion of enrollment for a Phase I dose-finding HER2+BrCa study.
They were experiencing slow enrollment due to a scarcity of comparator arm naïve subjects in the U.S, where the trial had been open for six months at seven different sites.
Past Experience With Reverse Feasibility Program
The Director of Clinical Operations knew Canada would be a viable option, especially after his company’s last study was completed three months ahead of schedule after engaging Scimega Research and tapping into the Reverse Feasibility Program’s network of Canadian oncology investigators.
Once again, the results exceeded expectations, as we were able to identify five qualified sites in less than two weeks. The sponsor then selected four sites and the average start-up time, from complete package sent (CPS) to site initiation visit (SI) was 14 weeks.
Enrollment Closed Three Months Ahead of Schedule
With only 33% of the study’s sites, Canada enrolled 55% of the patients and the study was closed to enrollment by April 2015 – three months ahead of schedule once again. The key has been to understand what drives enrollment. In other words, to understand what investigators are looking for.
Having been around since 1997 means the sites know, like and trust us. We execute a mutual CDA with the sponsor and request that they allow us to use our CDA template to share info with the sites. The use of pre-approved templates really helps accelerate the start-up process.
The sponsor was not the only one to benefit from this collaborative approach to clinical trials. Here’s what one of the principal investigators had to say about his experience.
“Thanks to the Reverse Feasibility Program and Scimega’s ability to attract pertinent clinical trials to Canada, several of my patients were able to LIVE significantly longer.”
– Dr. Cristiano Ferrario – Montreal Jewish General Hospital
This story is yet another example of how mobilizing an expert Canadian team can significantly enhance study start-up and overall clinical trial performance.
To learn more about making better site selection decisions download our Free Quick Reference Guide to Accelerating Site Start-Up by 50%..
Roberto Lara is the Director of Business Development for Scimega Oncology, a Canadian Oncology CRO dedicated to attracting cutting-edge studies to Canada and enhancing overall clinical trial performance. He has over 14 years of clinical trial management experience and is currently completing his MBA in Pharmaceutical Management from l’Université de Laval.