What’s Best for Your Phase III Clinical Study?

It’s worth your time to consider whether or not the commonly held belief that using a larger CRO for your Phase III study is the best course of action. In reality, the larger CRO may not effectively meet the personnel requirements for your scale-up to Phase III. This is particularly so for studies in critical indications such as oncology, neurological disorders, or orphan drugs for which a smaller, niche CRO may well be your best choice.

What’s the Difference, and Why Does it Matter?

The differences between how a large CRO and a more niche partner may scale-up to serve your Phase III study may not be readily apparent. Which is why it’s a wise practice to critically examine all the factors affecting scale-up to your Phase III study, and not simply take the larger CRO’s word for it.

Key among the factors to take into consideration, is not only therapeutic area, but the significant dynamics of business operations between the larger and smaller, niche CROs, and most specifically how such organizations scale up employee numbers.

Are the employees added in the scale-up to your Phase III study therapeutically aligned with your study and genuinely interested in advancing science relevant to the indication? In oncology and other critical indications any assigned personnel may perform the same job, but sponsors are more likely to encounter errors and/or costly delays when non-therapeutically aligned employees are assigned and learning on the job, and at your expense.

In reality, although their numbers of employees are greater, do large CROs in fact have more qualified personnel readily available to be assigned to the scale-up of your Phase III study than the smaller, niche CRO with its specific qualifications in your critical indication?

Sponsors working with larger CROs spend significant time chasing after, trying to track down, and find out what is going on with different aspects of their study, trying to determine who is handling what. In short, micromanaging their large CRO partner. To get answers, the sponsor is supposed to talk to the CRO project manager. Not infrequently, the project manager (who often changes every 2-3 months) doesn’t have the answers, and it’s rare that the sponsor has access to anyone else on their project.

The smaller, niche CRO that is well managed, with low turnover, and a clinical operations team populated with experts in oncology can provide a living archive from your Phase I through Phase III. At Scimega the same project team follows a Sponsor’s program from Phase I to II, and subsequently heads any scale-up to Phase III that follows. Thereby providing not only the necessary therapeutic alignment of personnel, but also the accessible knowledge of what is and has gone on with a study program from its outset.

A recent example of the value of this living archive occurred when one of Scimega’s sponsors was acquired by a larger sponsor, and the entire clinical study team of the initial sponsor subsequently moved on. This left no one in the larger sponsor’s team for the clinical trial project with any experience with or knowledge of the history of the project.  In such an instance, it was the smaller, niche CRO, Scimega, that was able to support the new sponsor’s newly assigned clinical project team, and provide the comprehensive history of the earlier study phases, and key aspects that had been lost in the sponsor’s personnel transition.

 A Region of Interest for Phase 3 Global Studies

For smaller biotech companies the stakes are high for any Phase III trial. With limited resources and pipelines, successful execution of a global Phase III 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 (1^st, 2^nd line, 3^rd line, etc.). A factor that greatly aids in identification of possible oncology trial participants.

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 III 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 25 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