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If you’re a member of the public looking for information about clinical trials and participation opportunities in Alberta, visit the Be The Cure website.
What is a clinical trial?
At the centre of all medical advances, clinical trials are research studies involving people. New medications are researched extensively in a lab before they’re ready for clinical trial with human volunteers. Before a treatment may be used in clinical practice, it must undergo a rigorous process. This includes lab testing, clinical trials, and review and approval by regulatory health authorities.
Clinical trials can test and evaluate treatments such as new medications, devices, diagnostics and procedures, and are the main way researchers discover if a treatment is safe and effective for humans. The various types of clinical trials include:
No matter how promising a new drug, vaccine, or procedure looks when tested in a lab or on animals, it cannot be approved for general human use until it has been carefully evaluated through several phases of clinical study with volunteer participants.
Clinical trials, especially those involving new medications, require a series of steps called phases where participants are closely monitored throughout each phase so researchers can learn about new medications in a gradual and safe manner. Clinical trials are typically done in four phases or stages. Each phase has a specific goal where information is collected to build insights that support the next phase of the research process. The clinical trial only moves on to the next phase when the previous phase’s results are considered positive.
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.
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.
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.
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.
Why do we need clinical trials?
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.
Who can participate in clinical trials?
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.