Clinical Trials – What are they and why do we need them?

Philip WelfordOver the past 43 years JDRF has funded tremendous amounts of diabetes research. In fact, to date, JDRF has funded over $1.7 billion of research globally. This has traditionally been scientific research; basically really smart people in laboratories looking at cells through microscopes. They have made fantastic strides in studying the disease and understanding what happens in the body when type 1 diabetes (T1D) is diagnosed. We have even cured the disease in mice over 100 times.

However, a number of years ago we realized that we needed to do more. We need to take some of those discoveries out of the labs and try them in humans. We are after all trying to cure the disease in humans not just mice.

How do we do that? Well that’s what a clinical trial does. First off we try a new drug, therapy or device in a very small number of people (often as little as 10 or 20) and we prove that it doesn’t harm people. After all, the first obligation of a doctor is to do no harm.

If it is proven to do no harm, we try the drug or device in a larger group of people to see if it gives better outcomes than the existing clinically approved procedure.

If that is the case then we try the same procedure in a much larger group of people (often into the hundreds or above 1,000). If this study produces the same results as the second one then we will go to Health Canada and get approval to sell the drug or device in Canada. At that point it is available for doctors to prescribe to patients. Of course then there are the problems with Provincial coverage but that’s a much longer discussion.

To go from an idea that works in a lab or in mice to being available for doctors to prescribe to Canadians living with T1D can take 10 - 15 years and cost $500,000,000 - $1,000,000,000. It’s a long and expensive process but it’s a necessary one to ensure that, as patients, we are using drugs and devices that are safe, effective and actually work.

Have a question about clinical trials in Canada? Post your question below.

Best,
Philip

Vice President, Strategic Partnerships, JDRF Canada
Former political staffer, businessman, entrepreneur, truck driver, and – best of all – farmer.

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Lets turn type one into type none