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Clinical Trials Series Part 1: What Are Clinical Trials and Are They Right for Me?

According to a 2014 study by the Canadian Partnership Against Cancer, less than 7% of adult cancer patients enrolled in clinical trials.1 This may be because many cancer patients are not aware of clinical trials, do not know how to enroll in them or are concerned that they are unsafe. In part one of our blog series on clinical trials, we explain what clinical trials are to provide you with the right tools to decide whether you should enroll in a clinical trial.

What Are Clinical Trials?

Clinical trials provide doctors with a way to closely monitor and test the best treatment, medical procedure or therapy for various diseases. These research studies improve standard of care as they can lead to newer and better ways to treat diseases with less side effects than the current treatments that are available. After a treatment is studied in preclinical trials using cells in petri dishes or animals, the next step is to study them in clinical trials using people.2 These trials help to determine how well a treatment works in comparison to currently available treatments and if it is safe for people.3

There are various ways to study the effects of a treatment, the most common ways being through interventions and observational trials. During interventions, the treatment being studied is administered to a patient to compare its effects to treatments currently available. Patients are put in one of two groups, an experimental group or a placebo group (also called the control group), usually without knowing which group they are in. The group of patients in the experimental group receive the treatment being studied and their side effects are closely monitored by the researchers and doctors in charge of the study. The placebo group, on the other hand, does not receive the treatment but instead continues to receive the current standard of care.4 During observational trials, there is no administering of the treatment that is being studied, instead, patients are simply ‘observed’ to determine their risk factors in getting a disease.5

The Four Phases of Clinical Trials

Clinical trials happen in four phases.6 In Phase 1, the treatment in question is tested on just a few people to determine its safety, associated side effects and the best dosage to use. The treatment being tested then moves unto Phase 2 where it is tested on more people. Once again, its safety is tested, and doctors continue to try to determine the right dosage to administer and try to understand how good the treatment is at treating the disease. Following that, the treatment is generally administered to thousands of people in Phase 3 while doctors continue to look at how effective it is and what its side effects are. Phase 3 also includes comparing the treatment being tested to the current standard of care. Once the treatment has been approved for use, doctors and researchers identify any other risks, benefits and other uses for the treatment in Phase 4.

Why Should I Participate in a Clinical Trial?

Clinical trials help to improve the standard of care by introducing more options to treat as well as to reduce the risk of diseases. They do this by allowing doctors and researchers to test what works and helps them decide whether the benefits of a new treatment are worth the associated side effects.7 Since patients are monitored during clinical trials, you can be sure that any side effects that come up during the trials will be attended to right away.

Although it is not to be expected of all clinical trials, some may compensate all or part of a patient's participation. Be sure to confirm exactly what will and will not be paid for before enrolling in a clinical trial.

How Can I Participate in a Clinical Trial?

There are many ways to learn more about clinical trials that are available to you. The first step would be to speak with your doctor or healthcare provider as they may be aware of some. However, that is not the only avenue. Clinical trials take place at various places, from cancer centres to universities to hospitals. Therefore, you can reach out to these institutions to ask about possible clinical trials that you may be eligible for. In addition to this, Clinical Trials Ontario has a website that lists all clinical trials that are available in Canada. Their website pulls information from ClinicalTrials.gov, a database that lists clinical trials from around the world, including Canadian trials.

Since clinical trials are heavily regulated, there may be specific patient characteristics they may only be interested in at the time, so be sure to confirm that you fit all eligibility criteria.

Photo by Olga Kononenko on Unsplash

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