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Where Are The Phase I And II Oncology Trials In Canada?

Where Are the Phase I and II Oncology Trials in Canada?

For every phase I and II oncology trial taking place in Canada, there are almost 8-fold more phase I and II oncology trials available and taking place in the US [1].

The vast majority of oncology clinical trials in Canada at any given time originate from biotechnology or pharmaceutical companies from the United States.

Canada’s own biotechnology innovation continues to improve, but the US will continuously eclipse the magnitude of our efforts and the number of clinical trials we could initiate.

While Canadians have distinct advantages in many areas compared with other developed countries across the globe, we also have many areas where we must advance if the health and quality of life of our citizens are to continue to improve.

One such area facing Canadians today is the stark reality that early-phase oncology clinical trials are disappearing from our country.

Phase I and II clinical trials involve novel anti-cancer agents, derived from the latest, cutting-edge science with therapeutic intent, most often in a wide therapeutic window for cancer patients who have exhausted all therapies known to provide clinical benefit, and can take place in oncology-focused units of varying size across the country.

This important avenue through which advanced, refractory, or recurrent cancer patients in our country might benefit, is being lost. Oncology clinical trials do continually make their way to Canada from the US, but they are disproportionately more often phase III trials.

For every phase III trial currently taking place in Canada there are twice the number taking place in the US [1]. Phase III clinical trials address an important need in the drug development process, but involve already established therapeutic agents often in a restrictive therapeutic window, and take place in a limited number of major metropolitan hospital centers that are most frequently among the largest in the country.

It is of critical importance to continue to attract phase I and II oncology clinical trials with cutting-edge, anti-cancer agents to Canada, making them available to all Canadians, for the benefit of us all.

There are three key initiatives proposed herein to stop and reverse the decline in oncology clinical research trial opportunities in the Canada 1) raise awareness of the issue, 2) educate and engage the stakeholders involved, and 3) develop strategic partnerships for action.

Education, engagement, and partnership between cancer patient advocacy groups, oncologists, health care centers, and other Canadian stakeholders, such as oncology-focused clinical research organizations (CROs) like Scimega, will increase the availability of exciting, new, oncology clinical trials for patients in our country.

Unlike phase III trials, why are the critical early-phase oncology trials not making their way to Canada for the potential benefit of Canadians?

Canada is Not a Primary Focus, Except for Canadians

The simple answer is that Canada is not the primary focus for CROs in the US hired to manage early-phase trials, and is not the primary focus for US drug developers, primarily US biotech companies, developing one or more anti-cancer agents in their product pipelines.

US drug developers don’t typically consider Canada as a ‘viable option’ for their clinical trials, either as an internal decision (a misinformed one we’ll soon find out) or for reasons likely promoted by their US-based CRO. This is in spite of a great number of benefits available to US companies in opening a clinical trial in Canada.

Once becoming aware of the many benefits of opening a trial in Canada (to be expanded on later) US drug developers frequently turn to a company like Scimega to oversee their Phase I and II oncology trials in Canada.

Commonly, this move is prompted by poor US enrollment success (for many potential reasons) and the need to expand ex-US. Or, the need to supplement their US-based CRO due to a failure to properly manage any existing Canadian trial sites that were in operation.

The US-Canadian Divide in Biotechnology Explains Our Differences

As is the case in any region there are subtleties to the clinical trial landscape in Canada. The country differs from the US in many ways and one requires appropriate expertise with intimate knowledge of our differences in order to avoid multiple, common pitfalls in study startup and effective management. How and why is Canada different, and why is the US the key source of oncology clinical trials for the country?

Simply looking at the nature of biotech research in Canada versus the US it is evident that the US biotech field is larger, to an almost 10-fold degree, than the Canadian biotech field, while interestingly Canada has nearly the identical numbers of researchers per capita suggesting this is not entirely a population-based outcome.

Although Canada has the same proportion of researchers (including medical researchers) within the population when compared with the US, it has roughly 10-fold less performance in any measure of entrepreneurship such as number of biotechnology companies, number of employees in those companies, company size, annual revenues, and many others.

In addition, clinical research centers in the US have a focus on entrepreneurship and revenue, while Canadian research centers’ primary focus is on medical/academic advancement and publication.

These reasons help to explain why the great majority of oncology clinical trials in Canada originate from the US.          

Canadian vs. US Biotech Research Performance 2014 [2]

Why Are Early-Phase Oncology Clinical Trials Important to Canada?

Canada has the capability to take on many more early-phase oncology trials and make them available to Canadian cancer patients. These cancer clinical trials are important to Canadians for two key reasons.

First, they provide options to Canadian patients that they don’t currently have, considering almost 8-fold more early-phase oncology trials are taking place in the US and available to American patients.

Second, and more importantly, early-phase trials allow us to participate in novel, cutting-edge clinical trials that may influence standard of care in oncology in our country.

Canadian Patients and Clinical Trials

An Ipsos Canada poll in early 2016 gauged Canadian patients’ views and opinions on clinical trials. In one finding, over 70% of patients with disease indicated their interest in participating in a clinical trial, while only 11% had ever been invited to one [3].

The patients polled by Ipsos Canada were not specifically cancer patients, but one could argue that for advanced/refractory oncology patients who have exhausted standard of care for their disease the number interested in a clinical trial would far surpass 70%.

Unfortunately, for those Canadian cancer patients interested in clinical trials, only 11% of early-phase oncology trials (79 of 712 trials from June 2015 to July 2016) taking place in the US ever make it into Canada [4].

Bringing Cutting Edge Oncology Research to Canada

To put this in greater perspective, consider the current development and advancement of the growing class of immune-oncology agents in North America and Europe. These exciting new therapeutic candidates are rapidly gaining evidence for their use in 2nd and 3rd line, and even 1st-line care regimens.

The clinical trial numbers demonstrate that 5- to 8-fold more phase I or II trials with these important anti-cancer agents are taking place in the US right now.

Key Immunotherapy Clinical Trial Availability US vs Canada [5]

For instance, for every 8 trials with pembrolizumab (KeytrudaTM) taking place in the US right now, there is only one in Canada.

In a hypothetical, but still very probable scenario, imagine a colorectal cancer patient in Canada who has failed all standard of care therapies known to provide clinical benefit for their disease. There may be 6 trials involving novel anti-cancer agents in the US in colorectal cancer from which they might benefit, but none of the 6 are available in Canada. In this scenario, the Canadian cancer patient would not have access to the same opportunity for care that the American cancer patient had.

This scenario should never be a reality.

For these exciting Phase I and II trials taking place in the US, it is also true that medical researchers taking part in those early-phase trials in the drugs’ development are much more likely to be invited to proceed with the Phase III development of those drugs at their centers. Participating in Phase I and II of a clinical trial has great advantages to Canadian oncologists interested in medical research.

Putting the Focus Back on Canada

When the American Society of Clinical Oncology (ASCO) published their stance on the importance of Phase I clinical trials 

the world-leading organization was primarily speaking to the critical importance of early-phase oncology trials to cancer patients within the American context. Why should this be any different from a Canadian standpoint? It is not.

Understanding the importance of Phase I and II trials in Canada and being aware of the decline in their availability, now we must turn to addressing ways that we can end their decline.

It is very important that Canadians work together to ensure promising new therapeutic candidates for cancer are accessible in Canada, to Canadians.

The Benefits of Running Clinical Trials in Canada

US biotechnology and pharmaceutical companies can easily include Canada in their oncology trials. We offer great benefits within our Canadian system for these companies that do expand or launch trials in Canada.

This includes a willing patient population as previously mentioned, as well as the lack of intense competition from some of the largest immunotherapy and other anti-cancer agents in development today.

Again, Canada has the need for these trials and we have the sophistication, facilities, and experience to run them. 

Our health care and regulatory systems, proximity to the US, valuable patient population, and medical expertise make Canada a very attractive target for those US cancer drug developers aware of these benefits.

What if US drug developers were made aware of, and took advantage of, the great clinical opportunities in Canada. What if all of their important trials were available here?

What If We Partnered for Change in Canada?

Patient Advocacy Groups: Awareness, Education, and Engagement

What if cancer patient advocacy groups within Canada were made increasingly aware of cutting-edge agents in phase I and II clinical trials that were available in our country? What if their patient populations were increasingly made aware of these options, filling more of the clinical gaps in cancer care?

What if the number of phase I and II oncology trials available in the country were increased and provided potential clinical and psychological benefit to an increasing number of advanced, refractory, or recurrent cancer patients?

Medical Oncologists: Awareness, Education, and Engagement

What if oncologists increasingly acknowledged the important role early-phase trials play in the care of Canadians with cancer?

Imagine I were to pose a question to medical oncologists across Canada. “Do you face no challenges in your 2nd or 3rd line treatment options for your patients?” Considering the opposite, “What 2nd or 3rd line treatment challenges do you face on a daily basis?” The important role of early-phase oncology clinical trials is evident when discussing the severe challenges medical oncologists face on a daily basis in the care of their patients with advanced, refractory, or recurrent disease.

What if oncologists across the country increasingly had cutting-edge, early-phase clinical trials available to them to address clinical needs they routinely face for their patients?

What if our unmet clinical needs could be directly addressed?

Health Care Centers: Awareness, Education, And Engagement

What if health care centers across the country devoted more resources and support for early-phase cancer research at their institutions to address the needs of their patient population and oncology care?

As already mentioned, these early-phase oncology trials have benefit for cancer patients therapeutically and/or psychologically, and there is an existing and increasing clinical need. Also mentioned, medical oncologists in Canada have multiple, often severe, clinical gaps in cancer care to fill on a daily basis.

There is room for most early-phase oncology trials from US drug developers to help fill these unmet clinical needs.

Partnership Within the Reverse Feasibility Program – A Call to Action

Scimega Research has been attracting US cancer drug developers to Canada for 20 years and providing oversight for their clinical trials. Our primary mission is to increasingly bring cutting-edge early-phase oncology trials to Canada and we’ve worked with medical oncologists and health care centers across the country. We’ve also created a program that directly benefits all stakeholders with an interest in early-phase oncology clinical trials.

Through Scimega’s Reverse Feasibility ProgramTM oncologists across Canada tell us their unmet clinical needs, and we find the US company offering the trial that meets their needs. The Reverse Feasibility ProgramTM meets the needs of oncologists, their patients and their clinics, all to the benefit of Canada and Canadians.

For Patient Advocacy Groups: A strategic partnership with Scimega would mean enhanced education and engagement opportunities with your partners and members regarding new, exciting oncology trials in, or soon coming to, Canada. For Scimega, the partnerships represents indirect access to cancer patients and their representative groups within the country, the ability to educate them on options for their care, and increased enrolment potential in the early-phase oncology clinical trials attracted to Canada.

For Medical Oncologists: A strategic partnership with Scimega through participation in our Reverse Feasibility ProgramTM would mean exposure to and access to an increasing number of relevant, new, cutting-edge clinical trials to potentially address challenges in your 2nd or 3rd line treatment options for your patients. For Scimega, the partnership would represent an expansion and strengthening of relationships within the Canadian medical community, increasing our oncology indication portfolio and robustness, greatly enhancing our ability to attract a greater number of more significant trials to the country.

For Health Care Centers: A strategic partnership with Scimega would mean increased support and exposure for the early-phase oncology research work taking place at your institution, in turn drawing increased funding support for facilities, overhead, and infrastructure, as well as increased training and development opportunities for staff. For Scimega, the partnership would represent an expansion and strengthening of relationships with oncology centers across the country as well as their medical staff, support staff, and administrative units, including contracts offices. Strengthened relationships with contracts offices at institutions is an essential component in effective and efficient negotiation of CDAs and CTAs during clinical study startup, drastically reducing the time needed to open a clinical trial at a study site. [6, 7, 8]

The stark reality of declining availability of early-phase oncology clinical trials in Canada requires active, rather than passive, measures to change this reality. Advanced, refractory, or recurrent cancer patients in Canada deserve to benefit to the same degree as our American neighbors. We should not simply accept something as trivial as a border across which medical innovation is disparate as a barrier.

It is of critical importance that we continue to attract these trials with cutting-edge, anti-cancer agents to Canada, making them available to all Canadians, for the benefit of us all. As discussed, education, engagement, and partnership initiatives between Canadian stakeholders should increase the availability of exciting, new, oncology clinical trials for patients in our country.

Working in collaboration with all Canadian stakeholders our primary mission is to satisfy unmet clinical needs in everyday cancer care and end the decline of early-phase oncology clinical trials in Canada.


 Contributed by: Nathan Currier PhD, Director, Oncology Strategy & Alliances

1) – Industry, interventional drug or biological, oncology trials in adults, currently recruiting. Search conducted Feb. 23rd 2017
2) Adapted from Ernst & Young, Beyond Borders Bio-technology Report 2015
3) Ipsos Canada 2016 survey commissioned by Clinical Trials Ontario (CTO) and the British Columbia Clinical Research Infrastructure Network (BCCRIN)
4) – 712 interventional, industry-led cancer Phase I or II trials registered in the US from June 2015 to July 201
5) – Industry phase I/II interventional oncology trials in adults, currently recruiting. Search conducted Oct. 12th 2016
6) ‘5 step’ fail proof strategy to effective Clinical Trial Agreement Negotiations part 1.
7) ‘5 step’ fail proof strategy to effective Clinical Trial Agreement Negotiations part 2.
8) 7 Tips for Efficient Oncology Study Start-up.
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