The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Myths exist to explain things we don’t understand, as well as to continue traditions and keep relationships and societies ‘safe’. People often adhere to a myth and perpetuate it in answer to a difficult question, ending all further inquiry into whether or not there is valid supporting evidence for the particular myth they’ve chosen to believe.
Surprisingly all humans are susceptible to this, even those of us in the scientific community pursuing cutting edge oncology clinical research.
Some of the Facts About Conducting Clinical Trials
Studies suggest that in the US an estimated 40% of the pharma industry’s R&D budget is spent solely on conducting clinical trials. Estimates are that nearly 85% of clinical trials fail to retain enough patients for successful study conduct. With over 90% of clinical trials failing to comply to predetermined completion dates, due to poor participant accrual and excessive subject dropout.
These are not myths! And given the resources at stake and the probability of delays and potential failure to complete a study in the US clinical trial landscape, one would expect considerable due diligence to be applied in finding ways to mitigate these obstacles.
Clearly Sponsors favor a CRO that can reach recruitment goals 10% faster, even when compared to 20% lower study costs. However, when discrepancies arise between CRO recruitment goal promises and actual performance this is where myths may be born to provide answers to some of those difficult questions that arise.
Interestingly too, just as believing in myths is intrinsic to our human nature, so too without prior experience with a provider, Sponsors may simply turn to one or another of the large CROs that dominate rather than explore performance areas where smaller or more focused CROs shine. All of us tend to resist change, even if it might be our best alternative.
The following case provides real world evidence of why it’s important not to overlook the specialized niche CRO when selecting the best option for your oncology clinical trial; to overcome the natural tendency to believe the myth, and undertake the due diligence necessary to best serve your possibility of successfully attaining your trial objectives.
What are the Myths?
“The Canadian population is too small for feasible participation in your trial!”
“Canadian Sites and Oncologists lack experience as world-class researchers!”
Evidence that Busts these Myths?
This pivotal P3 Solid Tumor study design required early trial participant catchment for a large number of participants.
To help beat the odds this Sponsor turned to a specialized niche CRO skilled in collaborative vendor teaming with 20 years unparalleled Canadian oncology experience, 100+ successful oncology clinical trials – never rescued by another CRO.
Scimega’s business model effectively supports US biotechs expanding their oncology trials to Canada. In record time, our proven feasibility assessment approach and team of oncology research experts engaged with key Sites; mapped the participant’s journey from Dx to Sx and Tx; customized a participant catchment process for the trial; developed and implemented cross-departmental communication workflows for this US Sponsor.
Busting these Myths with Real World Evidence of the Results Achieved
Canadian Sites surpassed enrollment by 237%
92% of opened Canadian Sites enrolled participants
Sponsor requested & received more Canadian Sites
Sponsor asked Scimega to share winning Canadian catchment strategies
With shared Canadian strategies:
Enrollment improved in other regions from 0.25 to 0.5 pt/mo/site!
Study enrollment closed on time!
Database lock as planned!
As a Canadian oncology CRO with a singular focus on oncology. We play a vital role in improving the speed and efficiency of oncology clinical research through a deep understanding of the needs of Sponsors, Investigators and trial participants.
Continuously making a difference in the area of cancer research is something our team at Scimega dedicates itself to every day. Busting myths fabricated by others with less specialized expertise that might prevent small and mid-size US biopharma from bringing their cutting-edge trials to Canada is all in our day’s work!
Contributed by: Julie Martin, Director, Clinical Operations