Successfully designing and conducting oncology trials is not getting easier. Many of the challenges we are facing in oncology research often involve a mix of trial competition over a small targeted patient population, evolving technology, numerous processes, the heavily regulated environment, and even the study design itself can be difficult. In addition, relationships between the Sponsor, vendors, and clinical sites are central to the trial’s fate.
Geographic Expansion: Key Success Factors
With ‘the devil in the details’, key success factors for geographic expansion include 6 primary vectors of action: clear goals regarding the expansion; a well-articulated game plan; a vetted CRO with quality experience in the region where the expansion is taking place; collaboration among all players involved in the study; efficient and transparent communication; and speed, especially if the expansion is used to help rescue a study gone off-track.
What Can You Achieve by Expanding to Another Region?
Your expansion plan should be specific to the risk and complexity of your trial – not governed by one-size-fits-all approach. When properly executed, a geographic expansion can do a lot for your trial:
- Expedite and/or Rescue Clinical Development
- Tackle a Difficult/Rare Patient Population
- Reduce Impact of Competing Trials
- Mitigate Risks of Enrollment Delays
- Complete Enrollment Faster
- Access Untapped Pools of Patients
- Facilitate Registration in Multiple Regions
A Canadian Expansion Strategy – Key Advantages
There is no question that the Canadian population is much less dense than in the US. However, when we look at participation rates for each country we see that rates are nearly 3 times higher in Canada than in the US.
In addition, when working with the right regionally specialized CRO in Canada, below are just some of the additional opportunities that will serve to contribute to the success of your geographic expansion strategy in the region.
◾ The nature and structure of the Canadian health care system results in patients being followed at the same center throughout the evolution of their disease.
◾ This represents a competitive advantage in regard to ease of access to historic data to precisely project enrollment performance.
◾ Pre-screening efforts are also facilitated by accessing specific sources of patients (example: follow-up on patients having received a 1st line therapy and ‘catch’ then when they progress).
◾ In Canada oncology patients are cared for within a network of cutting-edge comprehensive cancer centers across the country.
◾ Canadian oncologists do not compete for patient care, and both physicians and oncologists from nearby centers will happily refer patients to a care center running a trial.
◾ Oncologists have established referral systems, both within their own sites as well as from multiple other institutions across Canada.
◾ Taping into these referral systems increases access to specific disease indications – optimizing enrolment for orphan/micro populations.
Scimega Research is a specialized CRO with 20 years unparalleled Canadian oncology experience. For more information about the regulatory scene in Canada, please contact us to request our Regulatory Manifesto.
Contributed by: Julie Martin, Director, Clinical Operations