Basket trials, along with umbrella trials and platform trials, are classified as master protocols which…
All agree that ethnic groups are massively under-represented when it comes to clinical trials, and although barriers to diversity in trials are well recognized, sustainable solutions for overcoming them have proven elusive. Just as diversity in clinical trials means more than simply increasing the pool of ethnic groups represented; it also means including people from all walks of life.
Lack of diversity is an obstacle to understanding the safety and efficacy of novel therapies across population subgroups. Which is why there is such a push to include racially and ethnically diverse clinical trial participants, representative of the intended patient population likely to use a medicine once approved, to better inform the safety and effectiveness evaluation of investigational therapies.
We’re all talking about it, everyone wants it to happen, but how?
Similar to study protocol development for example, in order for sponsors to attain it ‘diversity’ must be unequivocally defined by your team for each clinical trial. More specifically defining diversity is best undertaken within the context of site selection strategy. And, most importantly you must determine if you will keep track of it during enrollment, and if so, how.
Attaining diversity – how do we do it?
Only CROs, like Scimega in Canada, with the necessary bandwidth for sites within their region and specialization have the capacity to provide sponsors with the ability to effectively include defined, measurable diversity targets into the feasibility approach and site selection strategy for your trial.
This means the CRO is equipped to share hard data for the measurable diversity indicators sought for your trial; has strong site relationships to access this data from sites; can confirm established, repeat experience with a wide range of sites in the region; and that all data provided can be cross-referenced with existing public stats.
Site selection – how to incorporate diversity into your strategy?
Key elements to look for from your potential CRO when it comes to attaining diversity targets for your global trial in any specific region include:
- During the bid defense and trial kick-off your vendor should push the door wide-open on the topic of diversity to clarify your expectations and targets as the trial sponsor;
- Seek specifics on how the vendor will roll your diversity targets into the site identification strategy;
- Look for confirmations from the vendor of prior experience, number of sites to contact, hard data derived through questions to sites about patient populations and time frames, that are cross-referenced with existing public stats.
Sites do have stats on diversity indicators such as race, albeit stats on these indicators may reside within different departments of the hospital such as medical records, pharmacy, research units, and elsewhere. Access to reliable data requires cross-functional corroboration on the part of the CRO seeking to determine site capacities to fulfill diversity targets for your trial. To do so, solid site relationships are a must to access this data quickly and efficiently from a wide range of sites in a particular region.
Part of attaining trial participant diversity is cultural. Which is why your vendor also needs to be proactive and alert to all current health care players in their region such as patient advocacy groups and emerging regional research centers. Patient advocacy groups can become a useful ally and sometimes release information about a trial through channels that are more readily accessible to a particular, non-traditional patient population that you may seek for your trial.
In order to stay current, Scimega’s feasibility team members invest time dedicated to networking efforts to remain on the cutting-edge of developments in the oncology clinical research sector in Canada. This is done at the company’s expense and is not charged to sponsors, though it does potentially benefit Scimega trial sponsors through exposure to what is available in the region to help attain diversity targets for their trials.
The high level of recruitment success in Canada is the result of a few key factors: universal, free access to healthcare; a diverse patient population; a more positive public perception of clinical trials than in other regions; and a vast national network for disease treatment.
Canada has one of the most diverse populations in the world, and is associated with the production of top-quality data in global studies. Scimega’s active network is composed of fifty oncology clinical research centers, with top global talent that foster this country’s solid reputation for research in clinical medicine, biomedicine, and science and technology.
While the landscape in Canada is generally quite favorable to the success of global studies, this isn’t an exhaustive list of the factors that make Canadian PIs some of the top patient enrollers, nor does it always translate into enrollment success for every study.
Unsurprisingly, enrollment success can vary from study-to-study, which is why it is vital for clinical trial sponsors to be selective about who they partner with in order to attain the right mix of patients for their global studies. A specialized CRO, like Scimega, with local expertise that can leverage the disease treatment networks effectively are often most successful at connecting Canadian PIs to the most relevant studies for the patient population they serve.
Interested in Learning More About the Canadian Opportunity?
At Scimega, we are proud to report that the sites and Canadian PIs we work with are often top enrollers in the global oncology studies on which we collaborate with sponsors.
As a niche Canadian CRO acting in Canada for the conduct of global cutting-edge oncology trials sponsored by mid-size and smaller biotechs, our oncology experts work with your team to devise innovative solutions specific to the unique challenges of your oncology clinical trial.
With a proven track record of 25 years unparalleled Canadian oncology experience Scimega guarantees sponsors the quickest site start-up and highest patient recruitment rate, without sacrificing premium quality data. With an optimal operations design robust enough to address an ever-changing clinical trial landscape.
If you’re interested in learning more about the Canadian opportunity, explore an expansion with us!
Contributed by: Julie Martin, CEO & co-Owner