Did you know that virtually every drug, such as basic cough syrups to powerful narcotics, must undergo a rigorous process of review for safety and effectiveness before it is approved for the Canadian marketplace?
Juvisync is a recently approved medication for type 2 diabetes management. The availability of this drug provides hope to many individuals with type 2 diabetes, high cholesterol and a high risk for cardiovascular disease who are not benefiting from current treatment options.
Before a drug like Juvisync can make its way to pharmacies, it must go through the clinical trial process. A clinical trial is a type of medical research that is highly regulated and monitored to ensure patient safety (for more information on this, check out our blog on Clinical Trial Safety). Clinical trials answer a particular question such as ‘how effective is this drug in lowering blood sugar levels in patients with diabetes’. The question evolves as the research progresses and more data is collected, and may change into something like ‘how does this drug work when it is taken with another drug that lowers blood pressure’? Generally, the drug is continually monitored after it is approved for the market to gain a better sense of how it works in the ‘real world’.
There are generally 3 phases of testing before each new drug is approved for sale, and typically one “post-marketing” phase. Each phase asks a different question. For example, during phase I, researchers are interested in determining the dose-specific chemical and biological effects of a drug (called pharmacokinetics and pharmacodynamics). During phase II the effectiveness of the drug at different doses is examined and during phase III the effects of the drug are compared to the already marketed best available treatment. Phase IV trials are ‘after-market’ trials since they involve the review of approved drugs to determine if and how they can be improved on. One common factor among all phases of testing is patient safety. Patients are usually required to come into a clinic or hospital more often than their regularly scheduled appointments so they can be monitored closely while participating in a trial.
If it wasn’t for patient participation in clinical trials, we would not be able to determine which drugs were effective for which populations. Without clinical research, doctors would not be able to prescribe insulin to patients with diabetes, or even pain killers for everyday aches and pains. The involvement of patients in clinical research helps advance medical research and brings us closer to treating and curing ailments and conditions that afflict us and the people we care about.
If you are interested in participating in a clinical trial please visit our Trials Page.