For Community

Phase 1 Testing for safety

Phase 1 trials involve testing the specific intervention being studied on human subjects (healthy participants) to establish the safe dose range and identify any potential side effects. These trials are short (typically two to three months) and generally involve 20 to 80 participants.

Phase 2  Does the treatment do what it is supposed to do?

A Phase 2 trial investigates the effects of the intervention being studied on participants who have the disease or condition that it relates to. This phase gathers information on side effects and typically takes one to two years to complete and more participants are involved than in Phase 1 trials.

Phase 3 How does the treatment compare?

Phase 3 trials confirm the effects of a treatment being studied and compare it with the usual treatment for a disease or condition the treatment was developed for. This phase gathers more information about the safety of the treatment, how well it works in the long-term, and how long its effects last. Phase 3 can vary in length depending on the disease or condition and usually involves 1,000 to 3,000 participants who have the disease or condition and are situated in  different regions of the world.

Phase 4 What happens in the long term?

Phase 4 trials are carried out after the treatment has received approval for use in Canada and is available to the public. This phase of the trial can also be called post-marketing trials and is used to compare the treatment to a competitor to explore additional patient demographics not studied in earlier phases, or for further study on side effects. This phase can also be used to determine if existing therapies should be replaced.

Clinical trials are crucial to determining cause and effect in human health. Clinical trials are important for discovering promising new treatments or new ways to use existing treatments for disease, as well as finding new ways to detect, diagnose, and reduce the chance of developing a disease. A clinical trial may look at how to improve life for people living with a life-threatening disease or chronic health problem, and can also assist in finding a disease early, sometimes before there are symptoms in order to prevent a health problem. Clinical trials help to answer questions around if a treatment works, if it works better than other treatments and if there are any side effects. Clinical trials help bring new treatments to market, provide research-based information, test safety and efficacy of treatments, and provide results that can be used to improve health and quality of life for many more participants.

Clinical trials and observational studies are vital to disease research. Without volunteer participation in clinical trials, ground-breaking treatments would never make it to market. However, all clinical trials have guidelines about who may participate. Guidelines are based on age, type of disease, medical history, and current medical conditions. In order to protect people who might be harmed by participating in the study, you must meet the inclusion criteria specific to each clinical trial.

The safety, rights, and well-being of every clinical trial participant come first. Clinical trials are vital for improving health care and discovering new treatments, but they must be conducted with the highest level of care, respect, and transparency. 

1. It All Begins with a Thoughtful Research Question

Before any clinical trial starts, researchers carefully develop a research idea with input from scientists, doctors, patients and/or community people with lived experience. This ensures the study has purpose and relevance.

2. Peer & Grant Review: Is the Study Worth Doing?

When researchers apply for funding, expert reviewers evaluate whether the study:

• Is scientifically sound and valuable

• Is safe for participants

• Respects communities and individuals involved

Only the best and most ethical studies are funded.

3. Health Canada Review

Health Canada’s specialized review groups (called Directorates) look closely at clinical trials involving drugs, devices, natural health products or biologics. Their role is to:

• Evaluate the safety and potential risks

• Ensure the study meets national regulations

• Approve the study only if it meets rigorous safety standards

4. Research Ethics Review: A Deep Dive into Respect and Safety

An independent Research Ethics Board (REB) reviews every trial to protect participants. The REB:

• Examines how participants are recruited and informed

• Ensures risks are minimized and clearly explained

• Confirms that participants can freely choose whether to take part

• Safeguards privacy, dignity, and cultural values

No study can begin without REB approval.

5. Site Initiation Visits: Getting Everyone on the Same Page

Before the first participant is enrolled, the CTO leads a site initiation visit with the research team. At this visit, we:

• Review the protocol and procedures

• Go over the consent process

• Double-check roles and responsibilities

• Make sure everyone understands how to keep participants safe

6. Ongoing Monitoring: Eyes on the Trial

We don’t just set up trials and walk away—we actively monitor them. This includes:

• Checking records to make sure participants gave proper consent

• Ensuring the trial is following the approved plan

• Watching for any signs of harm or distress in participants

• Addressing concerns quickly and responsibly

7. Quality Assurance: Built-In Safety Checks

Our Quality Assurance (QA) program adds another layer of protection. Through careful and detailed internal reviews, we:

• Double check that the monitoring activities are effective in detecting and correcting mistakes or missteps

• Identify opportunities for improvement (new training initiatives, new tools, new resources)

• Provide feedback and coaching to research teams

• Make sure the trial data is accurate and trustworthy

8. Quality Improvement: Always Getting Better

We use a “Quality by Design” approach to prevent problems before they happen. This means gather all of the information collected by the monitors and QA program and:

• Designing trials with participant safety at the center

• Collaborating with communities and partners to identify risks early

• Continuously improving how we run trials and support participants

Why It Matters

Every clinical trial participant is a partner in discovery. Whether someone joins to access new treatments or to help others in the future, they deserve to be treated with care, respect, and honesty.

At the Clinical Trials Office, we are committed to creating a clinical research environment that is:

• Safe

• Ethical

• Inclusive

• Accountable

• Community-focused

We thank all those who take part in clinical research. Your participation shapes the future of health.

Be The Cure

Visit Be The Cure to learn more about studies and how you can participate.

MyAHS Connect

MyAHS Connect is a secure, online, interactive tool, provided by Alberta Health Services that gives you access to your Connect Care health information. The health information viewable in MyAHS Connect is a reflection of the Connect Care record that your healthcare team uses. Any contributions that you make to your MyAHS Connect is viewable by your healthcare team and vice versa.

If you are interested, you can opt-in to learn more about studies that you may be eligible for. Learn more about activating your account and opting in to hear abour research studies here.