Benefits Of Conducting Phase 1 Clinical Trials In Canada

In the U.S., drug studies in humans are only allowed to begin after an Investigational New Drug Application (IND) is reviewed by the FDA and a local institutional review board (IRB). Sponsors must include the following in their IND:

• Data on animal studies and toxicity (side effects that cause great harm)
• Manufacturing information
• Clinical protocols (study plans) for studies to be conducted
• Data from any prior human research
• Information about the investigator

In Canada, sponsors are required to submit a clinical trial application (CTA) to Health Canada. Once the agency receives a CTA, its scientists review it to ensure drugs are used in the right way for the patients being studied; any risks in using the drug are reduced as much as possible; the best interests of the people taking part in the trial have been considered; the drug is manufactured appropriately; and the goals of the trial can be met.

Similarly, clinical trials conducted in Canada must follow Division 5 of the Food and Drug Regulations, along with Good Clinical Practices. The most current regulations under Division 5 were implemented to strengthen protections for human research subjects and increase research and development investment in clinical trials in Canada.

Features of Phase 1 clinical trials

Once preclinical testing is completed, clinical trial sponsors may move on to Phase 1 of clinical trials. This phase, which typically lasts several months, is usually conducted on 20-100 healthy volunteers or people with the disease/condition. Researchers in Phase I aim to find the safe dosage range of a new drug with the fewest side effects.

At the end of this phase, the results are collected and analyzed before being submitted to the appropriate regulatory agency. If approved, the sponsor can proceed with Phase 2, which is carried out to test drug efficacy and monitor any side effects. According to the FDA, approximately 70% of drugs that undergo Phase 1 move on to Phase 2.

It’s highly advantageous to collaborate with a contract research organization (CRO) with the vast experience, technical capabilities and talented personnel to run Phase 1 trials across many different therapeutic areas.

As a CRO with a large database that can perform high-volume studies and has sites in both the U.S. and Canada, BioPharma sponsors benefit from a one- or two-day turnaround time for lab data, resulting in quicker clinical decisions on the next ascending dose. This gives clients as much information as possible so that they can make the right decisions.

By offering a global network, CROs like BioPharma are familiar with drug markets around the world and able to conduct more complex studies. They have the expertise and equipment to bring challenging clinical trials in-house instead of sending some of the processes to an external site. When several sites are involved in a Phase 1 trial, it complicates the process and often necessitates separate ethics approvals onsite.

Benefits of conducting Phase 1 clinical trials in Canada

A reputable CRO stays up to date with industry regulations and can provide useful guidance about them to sponsors and other clients.

By far, the biggest advantage to using a company with a clinical trial site in Canada is shifting the FDA Investigational New Drug Application interaction until after you have gathered early phase clinical research data.

American regulations require sponsors to open an IND, but Canadian laws don’t necessitate such a protocol. Unlike in the U.S., Health Canada doesn’t recommend withdrawal of studies or perform clinical holds, which can be a death sentence for some companies. Instead of enduring the lengthy IND process in the U.S., sponsors can come to Canada and, once their clinical trial application is approved, they can begin and start producing data.

For many American clients, the primary appeal of a Canadian site is saving the extra time, effort and, in some cases, fees required by the FDA IND. They can get their individual studies approved more easily without needing to provide so much preclinical and manufacturing data, as the focus is less on the program as the safety of the protocol.

This enables companies to put off interacting with the FDA until a later date when they have more complete data. It shifts the conversation from what the FDA requires for a safe first in human study to what the expectations are for the Phase 2 studies. Furthermore, Health Canada is considered by many companies to be very accommodating, as it will offer recommendations for resubmission and work constructively to get a study approved.

In addition, with a study site in Toronto, BioPharma is able to utilize the city’s huge, diverse population, which provides access to a large sample of healthy volunteers who can participate in clinical trials. There are some financial benefits to using a CRO with a Canadian clinical site, as well.

At BioPharma, we conduct research studies across all medical disciplines and have extensive experience with Human Abuse Potential (HAP) assessment. In fact, our Chief Scientific Officer, Dr. John Oldenhof, has almost 20 years of pharmacology experience and has overseen more than 250 early phase and HAP and abuse deterrent assessment studies.

Dr. Oldenhof’s knowledgeable, hardworking team exemplifies BioPharma’s organizational culture as a small company that makes outsized impact. We have an industrious, entrepreneurial spirit and possess the nimble dexterity to adapt, pivot and problem-solve to suit client needs, delivering high-quality results quickly and accurately.

BioPharma Services has built a full suite of clinical solutions from Phase 1 to Bioequivalence Bioavailability services to assist our clients’ clinical drug development programs. Our clinical center in Toronto, Ontario have enabled sponsors to utilize resources in North America. To learn more about the services we provide and our talented management team, visit our website or contact us today.