Why participate in a clinical trial?
Clinical trial participation has been proven repeatedly to improve patient outcomes by providing access to new therapies and more frequent monitoring.
The World Pancreatic Cancer Coalition recommends that every person be given a chance to enrol in a clinical trial. Numerous success stories underscore the potential benefits of clinical trials; however, Canadian participation remains alarmingly low.
According to the University of Windsor, only about 7% of Canadians with cancer participate in clinical trials, and this figure drops by almost half in smaller provinces and rural areas (Sharma et al., 2022). In contrast, major centers like Princess Margaret Hospital in Toronto achieve around 21% engagement. This low engagement hinders Canada’s ability to advance cancer treatment and improve its stagnant survival rates.
So why do so little Canadians take part in clinical trials?
In our experience, while our oncologist in Newfoundland was dedicated and informative, she lacked the resources and time to explore or refer to clinical trials outside of Canada. She also told us that she was “unable to refer to trials outside of Canada.” Thus, the patient and their caregivers had to assume the role of an Oncologist with no medical background.
There is also a noted reluctance amongst some Oncologist to recommend patients to trials, at least some due in part to the fact some trials are too far outside the patients geographical residence, or they can also frequently be biased when it comes to clinical trials.
Oncologists are often overwhelmed with their workload, and without a specialized team to review and match patients with suitable trials, Canadians in remote areas face substantial barriers to accessing such opportunities. Some areas have no access to Clinical trials at all. (Abdel-Rahman, 2023).
The Canadian Cancer Clinical Trials Network (CTN) is working to close the gap between urban and rural communities in Canada. They created the Canadian Remote Access Framework for Clinical Trials, which uses telehealth and education to help bridge this gap (Dicks et al., 2021). They note that over 30% of Canadians live outside of major urban areas where the heaviest concentration of trials are conducted.
While waiting for more clinical trials to become available in Canada, especially in rural areas, patients and caregivers can look for trials outside the country.
Self-referring to Clinical Trials
Self-referral to U.S.-based clinical trials involves independently researching studies, understanding eligibility criteria, and directly contacting study coordinators.
For Canadians, it’s important to factor in logistical, financial, and legal aspects, such as travel, insurance, and visa requirements. Since your Oncologist in Canada may be hesitant or unable to refer to U.S. trials, you will also have to consider the trial’s timing, health status, performance status, and overall readiness for potential treatments.
Thoroughly evaluating these factors and having conversations with your Oncologist as well as study coordinators can help you make informed decisions about the trial’s benefits and obligations before committing.That said, it’s never to early to start reaching out at any point during your diagnosis.
Consider giving access to your email or sharing a common email address from a custom domain so that everyone can pitch in and reply to site coordinators when needed. Be sure to include trial IDs in subject lines so you can quickly reference which study you're emailing about.
Ensure somatic and genetic testing is completed by a reputable company as soon as possible. Biomarkers will determine your eligibility for clinical trial with a precision medicine focus.
Those who have treatment based on their biology live longer to Pancreatic Cancer Action Network. Your oncologist should have already had a discussion with you about testing and treatment options based on these tests.
Most, if not all, have strict “inclusion” and “exclusion“ criteria that are becoming increasingly focused on biomarkers as the medical industry researches how to attack these vulnerabilities in cancer's makeup.
We also want to acknowledge that matching with trials in Canada might not always be a great option to the limited set of clinical trials with a precision medicine focus for Pancreatic Cancer patients. When we looked at clinical trials in Canada, we were told at a second opinion at Princess Margaret that none of the trials offered at the time would be beneficial to my Mother.
If you compare the sheer volume of trials being conducted in Canada versus the United States, you‘ll quickly notice the difference between both locations. The availability of such trials was boosted in 2015, following the launch of the Precision Medicine Initiative by the Obama administration.
These recommendations are intended to provide an efficient and flexible regulatory oversight approach: as technology advances, standards can rapidly evolve and be used to set appropriate metrics for fast growing fields such as NGS. Similarly, as clinical evidence improves, new assertions could be supported.
The FDA has already streamlined the regulatory approach to Next-Generation Sequencing to keep up with the ”rapidly changing technology.” (FDA, 2024).
In Canada in 2021, consultations were held on Clinical Trial Regulatory Modernization, and progress can be monitored by viewing their Forward Regulatory Plan between 2024-2026 will include changes based on consultation feedback.
Canada has committed to and is making changes to clinical trial frameworks but the United States has been a global leader driven by an extensive healthcare infrastructure and clear commitments to NGS resulting in a much larger availability of trials focused on precision medicine.
If your interested in more in-depth coverage of Canada’s current regulations, processes and some of the barriers facing Canadians please check out the article below.
Xianjie Li
Why Joining a U.S. Clinical Trial Can be Tough for Canadian Patients
That‘s not to say planning to attend a clinical trial in the United States as a Canadian is easy—far from it. We’ve included some of the considerations to make before pursuing a clinical trial outside of Canada below.
Canadian Doctors Probably Won't Refer to Trials Outside of Canada
Canadian doctors (except for a small subset of doctors who have cross-affiliations with U.S.-based institutions) probably won’t refer you to clinical trials outside of Canada.
The regulatory framework residing over clinical trials in Canada is overseen by Health Canada under the Food and Drugs Act and the Food And Drugs Regulation which require that all trials must be reviewed by the Research and Ethics Board (REB). (Ethics, 2018, Section 11.1) Trials outside of Canada cannot be assessed.
The Canadian Medical Association also stresses the importance of high ethical standards including patient safety and transparency in trial processes.
Canadian oncologists therefore might be reluctant to refer to trials were they are uncertain the ethical standards which they are bound to will be met.
Limited Responses and Time-consuming Engagement
In our experience, only around 20-30% of clinical trials we self-referred to even return our calls or emails despite our mother matching inclusion and exclusion criteria.
We were fortunate to have both a bomb aunt who came through big time and her incredible boss, Irving and Toddy. You guys know who you are and gave us such hope when we sometimes thought we were about to run out.
These enormous acts of kindness got Mom into Johns Hopkins in Maryland, where she was given incredible care and a renewed sense of confidence.
My mom used to tear up whenever she talked about you guys. How humbled she was that you chose to care so much about her. I know she carried that love with her every step of her journey.
The United States has far more trials on developing drugs targeting specific biomarkers. For instance, at Johns Hopkins, at the first appointment we were already made aware of a soon-to-open trial in Maryland that targeted KRAS G12D which my mothers initial testing had identified.
There are many things to consider when entering a clinical trial in Canada. Still, even more so when entering a trial in the United States. You’ll need to consider accommodations and finances and ensure you’re asking what’s covered by the trial and what’s not. You’ll also need to consider that insurance policies will probably not cover you travelling outside of Canada.
Lastly, as much as we wanted to plan for everything with my Mom’s cancer, you must acknowledge that cancer can be unpredictable and things don’t always go according to plan. In our heads, we had three chemo treatment options- if Chemo A failed, we would go to Chemo B. If Chemo B failed too, we would move to Chemo C. Then we would consider Clinical trials. If only things were that simple.
This logic doesn’t take into account how our Mother felt physically after two failed chemo regimens. Her body could not tolerate the suggested immunotherapy, and by that time, her “ECGO” or performance status had already disqualified her from entry into a clinical trial. Only you can decide with your healthcare provider, or sometimes alone.
My mother trusted Chemo because she had a medical background and believed in its potential success. Perhaps clinical trials or immunotherapy wouldn’t have made a difference. She already stuck out twenty long months on the routine chemos with no targeted therapies available to her in a world where she was given three to a maximum of fifteen months. So much about this journey is unknown, but please do what’s best for you.
Clinical Trial Matching Tools
Since 2016, clinicaltrials.gov, a United States government database, lists trials conducted around the world, making information accessible to the public. This platform can be invaluable tool for Oncologists seeking to pair their patients with cutting-edge treatments specifically suited to their Pancreatic cancer diagnosis.. However, the site can be completely overwhelming for most without a medical background.
Further, it's not just about knowing the trials that exist; it's about understanding how to access them. Self-referral is often necessary, especially since Canadian doctors can't refer patients to international trials. Persistence is key in this endeavour, as trial availability can change rapidly.
Securing a spot in a clinical trial often requires the completion of genetic and somatic testing, which provides the biomarkers needed to match specific trials. Understand the eligibility criteria and dynamically search for trials by repeatedly checking with services like Pancan’s Clinical Trial Finder or MyTomorrows.
It's essential to prepare for logistical challenges, especially if the trial is in the United States. From accommodations to financing, every detail matters.
You don’t really need to waste time navigating the website as there is no shortage of organizations both in Canada and worldwide that will complete this search for you and simply provide you with a list. That being said, it becomes more difficult when you are required to self-refer.
Self-referral Practices
In smaller provinces like Newfoundland, it’s pretty much guaranteed that your options for enrolling in clinical trials will be severely limited. Self-referral to clinical trials is a proactive approach that can maximize your treatment options. If you’re planning on enrolling in a clinical trial based outside of Canada, this will likely be your only choice as Canadian physicians cannot refer to clinical trials located outside of Canada.
Remember that clinical trials are dynamic and new ones are added daily just as quickly as others fill up. A word of advice- don’t put all your eggs in one basket. Inquire relentlessly, reach out to as many as you can and then make a decision based on the ones who respond back. Many don’t. Don‘t take this personally and simply move on to the next. All of the matching services below are or course free to use.
Navigating inclusion/exclusion criteria
Understanding clinical trial criteria can significantly improve your chances of finding suitable options. Inclusion and exclusion criteria, while a necessary framework for clinical trials, can be intimidating to people with no medical background. They ensure that participants have specific characteristics needed to answer the research questions. These strict criteria can be based on age, gender, cancer stage, genetic background, and previous treatments received.
Generally, factors such as overall health status and tumour biomarkers play a crucial role in determining eligibility. For instance, advanced pancreatic cancer treatments often necessitate precise genetic mutations to match with clinical trials.
Creating a comprehensive patient profile that includes your biomarkers, health status, and treatment history will streamline the process of comparing yourself to various trial criteria. Thorough documentation and organized communication can significantly enhance your ability to find the most appropriate and potentially life-saving clinical trials.
Our approach at creating the profile below was to sort through as many of the active clinical trials for Pancreatic Cancer on ClinicalTrials.gov, looking at the most common criteria and filling in the values specific to my Mom so that we could then quickly know if my Mother was eligible for a specific trial. Obviously we are not medical professionals, so bringing your findings for your Oncologist to review is best practice.
We’ll be publishing a tutorial in the coming weeks on how you can complete a profile like the one above for yourself or your loved one. There have been so many advances in artificial intelligence and it’s become more accessible. You can input medical records to programs like ChatGPT and request the radiology findings be sorted into existing criteria values that you specify based on common criteria for clinical trials. On more than one occasion I’ve got great feedback from clinical trial study coordinators whom I’ve communicated with and included the patient profile above in our communication regarding my Mom’s application.
PANCAN's Clinical Trial Finder
This tool is only available for trials conducted in the United States. If you’re located in Canada, you can find the nearest US city and use its ZIP code to search for trials. You can use this tool to locate trials, but we recommend that you consult with a phone agent who can interpret your somatic and genetic testing results to provide personalized advice. It’s also much better to form a relationship with your Case Manager as PANCAN recommends you repeat a search every two weeks to keep your matches current and make you aware of new trials that might have opened.
MyTomorrows
The website has a clinical trial finder but doesn’t customize the results. Instead, book an appointment with their medical team to discuss your diagnosis and use the resources.
Antidote.me
Antidote
Can be used to search trials based in Canada and the United States, aims to simplify results from ClinicalTrials.gov, but does not customize results by biomarkers so can yield an overwhelming amount of trials.
Ancora
Ancora is an additional AI-enhanced search for Clinical Trials that is useful because it will ask you about your genetic mutations and the results of your test to match you to targeted therapies.
Canadian Resources for Clinical Trials
- Craig’s Cause Pancreatic Cancer Clinical Trial Finder™
- Canadian Cancer Clinical Trials Network | Clinical Trials Navigator
- Health Canada’s Clinical Trial Database
- British Columbia Cancer Trials
- Canadian Cancer Trials Group
- Clinical Trials Quebec
As we move onward through our Intro to Advocacy series, we will next look at the importance of Second Opinions on your journey, how they can influence your treatment and some of the ways which we applied advise from second opinions at Johns Hopkins to our local healthcare journey.
Alternatives to Clinical Trials
Clinical trials are ultimately what will advance cancer care and be the source of new treatment options and procedures, not everyone qualifies for a trial. Considering alternative programs like expanded access or compassionate use can be an option especially since waiting on drugs approvals may cost too much time.
US 🇺🇸
Compassionate Use: This is an individual request for access to an investigational drug for a patient who doesn’t qualify for clinical trials and has run out of available treatment options.
Expanded Access Programs (EAPs): These are broader programs where pharmaceutical companies make investigational drugs available to groups of patients, even if the treatments are still under clinical evaluation. These usually are structured programs offering treatments to groups of patients who meet eligibility.
🇨🇦 Canada
In Canada, the Special Access Program (SAP) , overseen by Health Canada assists Oncologists request experimental treatments for patients who have pancreatic cancer and have run out of all standard of care options.
What are clinical trials and why are they so important?
Clinical trials are research studies that try out new treatments, therapies or procedures in a structured setting where you are monitored. By nature, participating in a clinical trial improves patient outcomes as you’re getting a new treatment and being monitored more than you would otherwise.
The World Pancreatic Cancer Coalition recommends that every person explore clinical trial opportunities as they provide access to treatments that aren’t available to the public yet. PANCAN recommends considering a clinical trial at every treatment decision, not just when you think you’ve run out of options.
How can I find clinical trials that match my mutations?
In theory, you should be able to consult with your oncologist or case manager about what options might be a better fit for your situation. Many times, in smaller healthcare settings, you might find they let you know that you will have to do some legwork yourself, or maybe they don’t have the time to search for you.
Remember that matching services such as Ancora and MyTomorrows can help filter trials based on your diagnosis and biomarkers. The turnaround is usually pretty quick; you can call more than once.
As long as you have your testing results, you can utilize some of the search engines we’ve listed above to do some searching and pre-screening to find trials that may interest you. Ask your care team what specific mutations you have. These are usually short, i.e. KRAS-G12D, G12C, etc. These keywords can isolate which trials target your unique mutation.
What are Inclusion and Exclusion criteria?
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Inclusion criteria are the conditions patients must meet to participate in a clinical trial, such as cancer type, genetic mutations, or treatment history.
Exclusion criteria identify factors that would disqualify someone, like prior treatment failures or health conditions that could interfere with the study. Understanding these criteria is important, as these are usually not negotiable as they ensure the right patients are matched with the right trials.
Can I self-refer to Clinical Trials in Canada or the US?
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Self-referral is often necessary, especially when your oncologist cannot or will not refer you directly to international trials.
Self-referral involves contacting trial coordinators alone (or enlisting friends or family while you relax) and providing your medical history, including somatic and genetic testing results. Be persistent, as trial availability can change rapidly.
Be prepared to have your updated scans and medical records. A lot of repetition comes with self-referral, and drafting templates for first contact can save you a lot of time.
You will also need to consider the financial and emotional cost of attending a trial outside your local area. Things can get expensive quickly, so don’t be afraid to be direct: ask what the trial covers and what it doesn’t.
What should I do to prepare for a clinical trial?
Preparing for a clinical trial can feel overwhelming, especially if responses are slow or you don’t receive all the information you need upfront. Don’t get discouraged if this happens, and avoid focusing too narrowly on a single trial. Think of the process like a job interview—the better prepared you are, the better your chances of success. Following these steps will help you navigate the process efficiently and increase your chances of accessing the right trial for your needs.
Get Somatic Testing (Molecular Profiling or Next-Generation Sequencing) Done Early: Complete somatic testing—also called molecular profiling or next-generation sequencing (NGS)—as soon as possible. This testing identifies specific mutations in your cancer cells, which determine eligibility for precision medicine trials. Having these results ready will save time and allow you to apply for targeted trials immediately. Without this information, you may not qualify for certain trials, limiting your treatment options.
Review Your Current Treatment Plan with Your Doctor: Once you have your somatic testing results, discuss them with your oncologist to help coordinate your care. While the level of support may vary from person to person, at the very least, your doctor should confirm your understanding of your condition and testing results. This ensures you know what to look for when searching for trials. Prepare a list of questions before your appointment to make the most of your time, especially if your oncologist has a busy schedule.
Gather Your Medical Records and Prepare Questions: Collect your recent medical records, lab results, and imaging reports, as these are often required for trial screening. If the trial is ongoing, you may need to provide updated records regularly. Ask the records department if there are ways to expedite future requests, such as using email or an online portal.
Communicate with the Study Team: Engage with the trial coordinators early to understand the study’s purpose, goals, potential risks, and benefits. These conversations will help you assess if the trial is a good fit and clarify the commitment and procedures involved.
Evaluate Travel and Financial Considerations: Some clinical trials require travel, especially for Canadians outside Ontario, Quebec, British Columbia, or Alberta, where precision medicine trials are concentrated. Plan for transportation and accommodations, and ask if the trial offers reimbursement for travel expenses, especially for out-of-province or international trials.
Stay Informed and Monitor Deadlines: Clinical trials often have specific enrollment windows and capacity limits. Track these deadlines closely to avoid missing your opportunity. Maintain regular communication with the trial team to stay updated on your application status and next steps.
By following these steps in this order, you’ll streamline the process, avoid delays, and increase your chances of accessing advanced treatment options through clinical trials.
Are there financial assistance programs for clinical trials?
In general, financial assistance programs for Canadians specific to clinical trial participation are limited as they fall under the scope of investigational or experimental treatments which can mean limited or no government funding.
That’s one of the issues that we put forth in our petition “Ensuring Canada’s Commitment to Raising Pancreatic Cancer Survival Rates” considering the complete absence of trials with a focus in precision medicine outside of Ontario, British Columbia, Alberta and Quebec.
However, I spoke with national organization’s Chief Hope Officer clarifying whether or not that distinction is a challenge when it comes to accessing their programs.
Hope Air helps out almost 40,000 Canadians annually who need help getting access to various treatments and medical procedures and that can include participating in clinical trials. Hope Air reviews merit on a case by case basis.
What happens if I no longer qualify for a clinical trial?
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If you no longer qualify for a clinical trial know that it’s not the end of the road. Eligibility is dynamic and a number of factors can cause you to no longer qualify for a trial. That can be anything from disease progression (meaning your tumour has grown or spread) to recent lab results placing you outside the eligibility criteria. Speak to your oncologist to understand the reasons specific to the trial.
There are likely to be other trials that you are still eligible to apply for. The field of precision medicine is expanding quickly. When my mother discovered she had the common KRAS G12D mutation there were no trials in Canada and limited trials in the US. There are now options in Canada at Toronto’s Princess Margaret Hospital.
Don’t forget about Compassionate Use Programs. In some cases, pharmaceutical companies offer either compassionate use or expanded access programs which provide access to experimental treatment or drugs outside of a clinical trial when the standard of care is no longer working.
What are precision medicine trials and why are they so important?
Precision medicine trials focus on tailoring treatments to the individual characteristics of your cancer. Unlike the existing "one-size-fits-all" approaches, precision medicine uses genetic and molecular information to identify specific alterations or changes that have occurred in your cancer's DNA.
These mutations, or markers, can be associated with a higher likelihood of success for certain chemotherapies, guiding your treatment path to the most effective therapies.
In the context of clinical trials, precision medicine means researchers are studying therapies specific to those alterations that, if effective, will someday become a new standard of care. And every medicine we have worldwide was first approved through a clinical trial.
Knowing your mutations and obtaining genetic and somatic testing can help match you to ongoing trials that result in better outcomes.
📚Reference List
- University of Windsor. (2024). “Program boosting participation in clinical trials among Canadian cancer patients.” Daily News. Retrieved from https://www.uwindsor.ca/dailynews/2024-03-18/program-boosting-participation-clinical-trials-among-canadian-cancer-patients
- Sharma, A., Liu, S., & Liao, X. (2022). “Clinical trial participation and its impact on cancer survival: A comprehensive review.” Journal of Cancer Research and Clinical Oncology. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9520135/
- Abdel-Rahman, O. (2023). “Geographic Disparities in Access to Cancer Clinical Trials in Canada.” American Journal of Clinical Oncology, 46(11), 512-516. https://doi.org/10.1097/COC.0000000000001039
- Dicks, E., Pond, G., Gan, H. K., Pond, G., Gan, H. K., … & Maroun, J. (2021). Bridging the Gap: Enhancing Access to Clinical Trials in Underserved Areas in Canada. Current Oncology, 28(5), 329. https://www.mdpi.com/1718-7729/28/5/329
- U.S. Food and Drug Administration. (2024). Precision Medicine. Retrieved from https://www.fda.gov/medical-devices/in-vitro-diagnostics/precision-medicine
- Ethics. (2018). Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – Chapter 11: Research in Specific Populations. Government of Canada. Retrieved from https://ethics.gc.ca/eng/tcps2-eptc2_2018_chapter11-chapitre11.html
