Clinical research is an important investment for the entire supply chain, from ingredient companies to brands selling finished health products. Primary research serves many purposes, and is most commonly used to validate efficacy, safety, and substantiate claims that increase the impact of a company’s marketing messages.
Canada is recognized on a global scale for its quality of clinical trials and expertise of research clinicians, and captures 4% of clinical trials around the world.
There are many logistical differences between running a trial in Canada versus the U.S., and several advantages to carrying out clinical research in Canada. Read on to learn more about how our company can benefit from bringing your research north of the border.
1. Regulations governing natural health products in Canada provide additional regulatory oversight for your study
In Canada, the regulations governing natural health products—the Natural Health Product Regulations—came into effect in 2004. These regulations brought new challenges to the industry; however, Health Canada has worked diligently over the last years to streamline operations to provide quicker market access and faster turnaround times on clinical trial application reviews.
While the additional step of a clinical trial application is not required in the United States, the review of the study by Health Canada provides additional regulatory insight. Health Canada reviews aspects of the study design such as sample size determination, duration, endpoints, appropriateness of the population, safety of the subjects, and comments on the overall merit of the study. As part of the clinical trial application, quality information regarding the study product is submitted, which can be cross-referenced for future product licence applications or clinical trial applications, expediting those processes. Conducting studies in Canada helps sponsors gain a competitive advantage as they are exposed to a level of regulatory scrutiny that they would not otherwise receive.
To minimize the impact on the timeline of a Canadian study, several initiatives can be taken. For example, obtaining ethics approval may be done once initial feedback is received from Health Canada so that both Health Canada authorization and ethics approval are received at the same time. Identifying potential candidates through electronic medical record review can also be performed prior to ethics approval to speed time of recruitment. Currently, a well-compiled clinical trial application will usually be reviewed by Health Canada in approximately three to 6 weeks from time of filing.
A Health Canada review is not always required. For example, if a product has a valid licence in Canada (known as a Natural Product Number, or NPN) and is being compared in a bioavailability study to another product that has a valid NPN, a Health Canada application may not be necessary as this may be considered a post-marketing study. Similarly, food trials which study the effects of foods that are available in Canada do not require approval from Health Canada, and only require review by an ethics board.
2. Trials on natural health products can be conducted without the need for an IND application
Conducting natural health product clinical trials in Canada allows the Sponsor to investigate populations and endpoints that could otherwise trigger the need to file an Investigational New Drug (IND) Application in the U.S. Depending on the product’s position in the marketplace, filing an IND can trigger a cascade of events that could;
a) result in adulteration warning letters from the Food and Drug Administration (FDA)
c) require that the Sponsor list the trial publicly on a registry such as clinicaltrials.gov. While it may be advantageous to list on clinicaltrials.gov for publication purposes, it also provides a public forum to see what the competition is researching.
Canada is an ideal country to conduct drug development research for natural health products/supplements as it can be conducted under the natural health product regulations and GMPs while still having regulatory oversight. This allows companies to see if their product has potential as a pharmaceutical agent before investing the substantial amount required to change manufacturing and file an IND in the U.S. Upon success, the information can be used in the IND application process to transition the dietary supplement to a drug in the U.S., without affecting any current marketing of the product as a dietary supplement. Moreover, positive research conducted in Canada on at risk populations can be used to support claims in both countries, thereby preventing FTC action.
3. Canada’s healthcare system helps ensure that research participation is truly voluntary
Canada has a Medicare system, meaning that participants who volunteer for clinical trials are doing so because they are interested in being part of research and future health care options, rather than as free medical advice and/or treatments. Canada has high standards with respect to human rights and ethical treatment of clinical trial participants, and there are additional ethics requirements that are not present in the U.S. For this reason, all research ethics boards in Canada can oversee research conducted in Canada as well as in the U.S., but not all U.S. research ethics boards can oversee research conducted in Canada.
Process Differences in Canada vs. the U.S.
|Products are regulated under Health Canada’s Natural Health Product Regulations (NHPR)||Products are regulated under the Dietary Supplement Health and Education Act (DSHEA)|
|Natural health product clinical trials are regulated by Health Canada under NHPR||Dietary supplement clinical trials are not regulated by the FDA|
|Clinical trials require pre-approval by Health Canada before they can begin||N/A|
|Requires ethics review||Requires ethics review|
|Can study non-disease and disease states||
Can study non-disease states only
Benefits of Conducting Clinical Research in Canada vs. the U.S.
|Regulatory review by Health Canada to ensure study design is appropriate||
Faster start-up time
(~1-6 weeks faster than Canada)
|On positive results, can make more aggressive claims||Can only support structure-function claims|
|Studies are non-IND and there is no requirement to publicly list the trial||Potential to trigger an IND which requires the Sponsor to publicly list the trial on clinicaltrials.gov|
If you choose to conduct your clinical research in Canada, it can be advantageous to seek out an experienced CRO with a strong track record and wide range of expertise in the natural health product, supplement and pharmaceutical space. As a solution provider, Nutrasource regularly conducts and manages all aspects of clinical development program in-house including:
- Natural health product and pharmaceutical product development strategy plans and their management;
- Filing clinical and market access regulatory applications for approval;
- Protocol writing and design compliant with industry and regulatory standards;
- Site selection and management;
- Recruiting and seeing study participants;
- Clinical data management in a 21 CFR Part 11 environment;
- Statistical analysis and report writing.
Our unique combination of experience and expertise in marketed health products, including both natural health products and pharmaceuticals, provides Sponsors with an unparalleled advantage in designing and conducting cost-effective clinical studies to withstand the rigorous scrutiny of Health Canada, the FDA and Federal Trade Commission (FTC), and the European Food Safety Authority (EFSA) for claims substantiation, product development and unique market positioning.
To learn how Nutrasource can assist with developing, planning, and executing your regulatory and clinical research strategy, contact us today.
Josh Baisley, B.Sc., is Director of Domestic Clinical Trials at Nutrasource. With nearly 15 years of experience in quality assurance, clinical, pre-clinical, and regulatory affairs for the natural health products sector, Josh has been directly involved in over 65 clinical trials accounting for more than 10% of all clinical research applications received by Health Canada. Connect with Joshua on LinkedIn.