The TMF is the official record of the clinical study for Regulatory Authorities, be it…
Pre-pandemic oncology was both the largest and fastest growing therapeutic area in the clinical trials market. A key market trend in relation to the phases of clinical trial research predicted to continue into 2024 is the expectation that the market will be dominated by Phase 3 trials.
It is likely to be a while before new oncology study launches are back up to the rate they once were. At the same time, the fight for a cure for cancer continues with Oncology receiving the most funding in private and public financings, and the most M&A related deal activity, by far in 2021. While the Nasdaq Biotech Index is expected to record another 20+% return this year.
Encouraging too are study stats and the anecdotal evidence that disrupted cancer trials are getting back on track at an increasing rate. Although there is country-wide variation in what trial sites are managing to do, as well as the global problem of a backlog of recruitment for existing studies.
A Region of Interest for Phase 3 Global Studies
The larger patient pool necessary for Phase 3 trials often requires a global scope, in addition to laying the path for eventual drug approval requests in more than one region. Conducting a Phase 3 oncology trial across multiple regions also allows for access to a more demographically diverse patient population and mitigates different types of enrollment barriers. Canada is a key region to achieve these objectives.
For smaller biotech companies the stakes are high for any Phase 3 trial. With limited resources and pipelines, successful execution of a global Phase 3 trial is critical as outcomes may determine the future of the compound and possibly the ultimate survival of the company itself.
Participation by Canadians in oncology clinical trials is 14%. Nearly triple the 5% participation rate in the U.S. Projections to 2036 indicate people of color will make up about one third (31% to 36%) of the total Canadian population. A diverse population combined with a universal healthcare system for all Canadian citizens offers a compelling opportunity for cutting-edge U.S. biotechs striving to ensure global trials get the right mix of participants.
In Canada cancer patients are funneled through select oncology health centers across the country and will typically receive treatment at the same center throughout the evolution of their disease (1st, 2nd line, 3rd line, etc.). A factor that greatly aids in identification of possible oncology trial participants.
Canada currently ranks 5th among countries (excluding the U.S.) that contribute the greatest number of clinical trial participants globally. While the number of physicians per population has increased in Canada over the past decade, and is expected to continue to increase for the next several years.
Results Achieved with the Right Partner
Year-over-year the attributes Sponsors seek from their clinical trial outsourcing partners remains the same. Quality and reliability are the number one and number two priorities. The right partner will integrate your study plan seamlessly, bringing key mitigating actions and solutions throughout the study conduct, without adding administrative or logistic burden to your team members. This is critical at the early stage of clinical development, and even more so at the late stage when trial scope is broader, and a greater number of players are involved.
Based on the metrics achieved by Canadian oncology CRO, Scimega, biotechs developing cutting edge oncology therapies with this partner are quoted as being very impressed with where Canada stands in comparison to other regions.
Scimega guarantees Sponsors the quickest site start-up and the highest patient recruitment rate, without sacrificing premium quality data. Identification and qualification of the right Canadian sites for each study is completed within just a few weeks thanks to Scimega’s extensive network of Canadian Investigators. These Canadian sites are then activated 50% faster than the industry average, and frequently emerge among top enrollers in sponsors’ global oncology studies. This is achieved even under the current pandemic circumstances.
What Your Specialized Oncology CRO Can Do for You – Real World Evidence
Mobilizing an expert Canadian team significantly enhances study start-up and overall performance. The following real-world case featured here highlights how an unwavering strategic focus of a specialized oncology CRO delivers on its commitment to the Sponsor’s program.
The case in point is a sophisticated global Phase 3 immuno-oncology study in mRCC sponsored by a U.S. oncology biotech that had been ongoing for 14 months in other global regions with slow enrollment due to logistical complexities associated with fresh tumor sample collection & access to a leukapheresis lab.
The client was told by their Global CRO that expansion to Canada was not a good option.
Happily, an encounter with Scimega convinced the Sponsor’s clinical operations team otherwise, and proof of the wisdom of their decision was quickly delivered when Canada started-up 5 sites in just over 9 weeks.
Further evidence of this right choice came with Canadian sites’ recruitment performance outstripping that of European sites’ performance by 2.5:1 patients/site.
Given its stable, experienced teamwork and ability to identify, advise on, and implement enrollment strategies within the complex field of oncology clinical research this specialized oncology CRO was instrumental in developing the solution to get this important global trial back on track.
Your Specialized Oncology CRO – Scimega Consistently Goes Above-and-Beyond
With 23 years unparalleled Canadian oncology experience Scimega Research has an optimal operations design critical to its ability to consistently go above-and-beyond for every one of your studies.
Scimega is a Canadian niche oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies. We consistently deliver our services with a strategic focus on Sponsor program success with clinical trial start-up times 50% faster than the North American average, premium quality data, and trial sites that are often among top enrollers in our Sponsors’ global oncology studies.
Contributed by: Julie Martin, CEO & co-Owner