Clinical research plays a crucial role in advancing medical knowledge. Researchers need people to participate in study trials to improve health care and the quality of life for patients and families.
Why should you participate?
- Contribute to important health research and innovation.
- Help yourself and others by advancing medical knowledge and patient care.
- Access cutting-edge diagnostics and treatments.
- Gain additional support and care from a clinical research team.
What is a clinical trial?
A study that enrolls human participants to evaluate the effects of a certain treatment or intervention on health outcomes. Researchers can test and compare methods for the prevention and detection of specifi c diseases and conditions, or gather data from specifi c populations. New or improved treatments often begin in a lab before moving on to testing with human participants.
Not all clinical trials are about drugs, medical devices or treatments. They also help develop screening processes and prevention methods to fi nd diseases earlier or prevent them altogether. The value of lifestyle changes like exercise and diet are also studied through clinical trials.
Who is eligible to participate?
Anyone can participate in a clinical trial, whether you’re a healthy individual or have a current medical condition. Eligibility criteria exist for every clinical trial, and could include age, gender, type and stage of disease, previous treatment history or other medical conditions.
Participation is always voluntary. Prior to enrollment in a clinical trial, you will be provided with information so you can understand the risks, potential benefi ts and alternatives to the study. Throughout the course of the study, new information may be provided and you maintain the right to withdraw at any time.
The four phases of clinical trials
PHASE I - Is it safe?
A Phase I clinical trial is the fi rst time a treatment or intervention is tested in humans. Serious immediate side effects have been ruled out, and now the treatment or intervention is ready for humans under careful observation. These trials are typically very short (two to three months) and involve a small number of participants, often those who are not experiencing major health challenges.
PHASE II - Is it effective?
Once the safety of a treatment or intervention is established through the fi rst phase, it moves on to Phase II to test whether or not the treatment or intervention does what it’s supposed to do. Positive or negative eff ects are recorded. These typically last one to two years, and involve participants who have a relevant disease or condition.
PHASE III - How does it compare?
During a Phase III clinical trial, the eff ects documented during Phase II are confi rmed, and might be compared to a conventional treatment. More safety information is also collected. These trials vary in length depending on the disease or condition. Participant groups are much larger and individuals are randomly put into groups which will receive either diff erent variations of the treatment or no intervention at all. These are known as Randomized Controlled Trials (RCTs), and both the participants and researchers are purposely left unaware of who is receiving what intervention in an effort to decrease bias and avoid, as much as possible, any placebo effect.
PHASE IV - Long term effects?
Once a treatment or intervention makes it past Phase III, it is approved for use in Canada and is made available to the public. Phase IV clinical trials, also known as post-marketing trials, might compare the new treatment to other alternatives, study the treatment in different human populations or look for any further side effects. This phase usually involves use under less controlled conditions and in real-life applications.
How to find a clinical trial
If you are interested in participating, you are encouraged to ask your primary care provider about any that might exist for your particular disease or condition.