The TMF is the official record of the clinical study for Regulatory Authorities, be it…
There is a myriad of factors involved in selecting a CRO. Do CRO team members have the necessary therapeutic expertise? Will the CRO have sufficient access to patients? Does the Principle Investigator have sufficient experience? Will the trial be completed on time and within budget?
What Sponsors Prefer
Selection criteria used by Sponsors of clinical CROs is primarily focused on finding the right match in ‘chemistry’ between the two organizations. Findings indicate that Sponsors are most concerned by factors such as: the CRO’s overall experience in the study’s therapeutic area and experience in the same indication (61%); can the Sponsor work with the CRO (63%); and the perception by the Sponsor of the CRO’s dedication (62%) according to a Biopharm International survey.
In its CRO Benchmarking Report when comparing CRO strengths and offerings Industry Standard Research identifies clear Sponsor preferences of 75% versus 25% on two key trade-off scenarios.
It found that Sponsors clearly prefer handing over control of site selection to their preferred CRO in return for recruitment guarantees. And that Sponsors favor a CRO that can reach recruitment goals 10% faster when compared to 20% lower study costs.
Real World Evidence with Real Results
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.
With 20 years unparalleled Canadian oncology experience, 100 successful oncology clinical trials – none of which have ever been rescued by another CRO – U.S. drug developers often turn to Scimega upon realizing program timelines and targets aren’t being met, and marvel at what is then accomplished. This track record in assisting Sponsors includes clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies.
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.
In this phase 2 oncology clinical trial in hematological malignancy the US Sponsor needed to overcome stalled study progress due to 1 cohort. The challenge was that the study team provided to the Sponsor by their large CRO was unsuccessful in identifying Canadian Sites.
Which is why the Sponsor turned to the specialized niche expertise of the smaller more focused CRO team of Scimega. Through its Reverse Feasibility Program™ very rapidly interested, suitable sites were identified providing expedited start-up in Canada.
What’s more, not only the problematic cohort was filled, additional patients were enrolled in other cohorts and the program successfully advanced to phase 3. This resulted in Canadian sites contributing 21% of patients towards global enrollment for the study.
What Not to Overlook
The estimated global CRO market for 2018 of $36 billion US is expected to grow to more than $45 billion US in 2022 (Grand View Research). Navigating the selection process of service providers by Sponsors within an industry of this size and scope, with its offering of services critical to the business success of Sponsors and the health and welfare of patients, is not easy.
Nevertheless, it’s clear from the above example that identifying and exploring the performance areas where smaller or more focused CROs excel is important when considering what to look for when selecting the right CRO for any particular aspect of your program, or to address new challenges to be overcome within a specialized expertise such as oncology clinical trials.
Contributed by: Julie Martin, Director, Clinical Operations