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Key Driver for Change in Oncology Clinical Operations in 2024 and Beyond

The need to transform traditional clinical trial process to a leaner and more cost-effective model is increasingly important. Some forward-thinking companies have begun to see success as they explore and embrace new ways of working. This ability to react to changes as they emerge in today’s rapidly evolving landscape for clinical research is the key driver for change in 2024 and beyond.

Consistent, effective process improvement can reduce delays and improve data accuracy in clinical trials where turnaround time and data accuracy are critical. The estimated cost of a one-day delay in a drug being brought to market can be significant. Just as paperwork-based errors in the clinical trial process – whether they occur at the sponsor level, the contract research organization (CRO) level or the institutional review board (IRB) level – can result in serious effects that can negatively impact study efficacy and time-to-market.

Looking to a Leaner Future with Methodology & Tools to Benefit Your Clinical Program

Clinical trial sponsors with concerns about timeliness, and quality of results will clearly benefit from a clinical operations team that is Lean Coached with the following attributes:

  • A clear focus on activities and processes designed to deliver on your clinical trial what you want when you want it, in regard to feasibility, enrollment, first patient in, eTMF, and any other attributes that are absolutely crucial to your trial;
  • The elimination of process variation and inconsistency in clinical trial activities;
  • Targeted improvements that provide the greatest efficiency, effectiveness, and agility for the achievement of optimum engagement for your clinical trial regarding both sites and patients.

A Lean Coached CRO’s clinical operations team delivers the benefits outlined above because the Lean quality management methodology implies a structure that supports designing all processes to deliver the clinical trial sponsor impeccable trial monitoring results.

Canadian Landscape for Cancer Research in Review

Canada’s World-Class Researchers: and diverse patient population make it one of the top 6 countries in the world for enrollment of clinical trial patients according to the FDA’s global clinical trial report. With a population of 37 million, this ranking indicates that Canada has a disproportionately large number of patients willing to participate in global studies.

Top-Quality Data: Canada is associated with the production of top-quality data in global studies. Success in this area is attributable in part to the Canadian government’s ongoing financial support which is helping staff Canada’s oncology clinical research centers. While top global talent foster this country’s solid reputation for research in clinical medicine, biomedicine, and science and technology.

Consistently High Enrollment: in addition to the quality of data coming from Canada, the country is one of the most efficient at overcoming barriers to enrolling patients; placing it among the top 4 countries in North America and Western Europe known to be the quickest to enroll patients following trial site initiation.

Canada’s success in patient recruitment is the result of a few key factors:

Universal access to free healthcare – is due primarily to Canada’s publicly-funded healthcare system and concentrated population distribution. In general, Canadian residents seek medical care more readily than their counterparts in privately funded healthcare systems without worries about cost or insurance restrictions. With nearly two thirds of Canadians (78%) living within 160 kilometers (about 100 miles) of the U.S. border there is relatively easy access to publicly funded healthcare. As a result, Canadian PIs have access to a large patient population despite the country’s population size and geographic size.

An additional factor that gives Canadian PIs an advantage with respect to patient enrollment is the diversity of the patient population. Canada is one of the most ethnically diverse countries in the world. This aids Canadian PIs to readily recruit a broad and diverse range of patients for global studies. Although this does not necessarily result in a higher absolute number of patients enrolled, it does provide diverse representation in global studies. A factor that usually results in improved safety profiles for potential drug candidates.

Public perception of clinical trials in Canada is the third factor that contributes to the success of Canadian PIs when it comes to patient enrollment. Surveys show that Canadians perceive clinical trials to be positive because of the societal and personal benefits they provide. Researchers have found that most Canadians (68%) are somewhat (49%) or very willing (19%) to participate in clinical trials.

Yet another factor that contributes to Canadian PIs’ success in patient enrollment is the vast disease treatment networks that allow PIs to coordinate research across multiple centers of expertise. These networks use provincial and national patient databases maintained by government agencies such as Cancer Care Ontario to connect medical experts and patients to clinical trials; in turn, Canadian PIs are able to easily screen and find suitable patients for participation in their global studies.

The Caveat – Choose the Right Partner for Your Study in Canada

Unsurprisingly, as in any other region, enrollment success can vary from study-to-study in Canada. Which is why it is vital for clinical trial sponsors to be selective about who they partner with to recruit patients for their global studies in the region. Specialized CROs 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 say that the over 50 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 biotechs, our team is skilled in collaborative vendor teaming. 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, Scimega’s team of Lean Coached oncology experts go above-and-beyond for your study to provide:

  • Local, full-time, permanent hires result in exceptional staff quality, consistency & reliability;
  • Extensive network of Canadian Investigator Sites frequently emerge among top enrollers, and are activated 50% faster than average for global studies;
  • Optimal site engagement to maximize quality, timely data entry and query resolution;
  • Robust and Lean Scimega methodology and processes are supported by current technology to keep every trial this CRO monitors on the Lean trajectory.

Our Lean Coached oncology experts work with your team to devise innovative solutions specific to the unique challenges of your oncology clinical trial. If you’re interested in learning more about the Canadian opportunity, explore an expansion with us!

Contributed byJulie Martin, CEO & co-Owner

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