October 31st – November 4th is Patient Safety Week in Canada, making it a great opportunity to discuss patient safety in clinical trials.
There is a large misconception of clinical trials as unsafe and dangerous and this may be because of media representations of clinical researchers as greedy and inhumane mad scientists. However, clinical researchers are not at all like Dr. Frankenstein but are instead interested in finding better solutions to current health problems. Moreover, researchers usually don’t recruit patients who are seeing results from their current medications but rather want to see if a new treatment will improve the health of patients who are not benefiting from their current treatment.
All trials that are done at CCCT follow a very specific protocol (i.e. set of instructions) which are designed to ensure participant safety. These protocols must receive legal and ethical approval before a trial can take place. This means that participants can rest assured that they are not given a drug that has not been reviewed for safety and would make their skin turn green!
Additionally, all trials require the oversight by a qualified healthcare professional at all times. This is done so that if an undesirable event does occur (such as a drop in blood pressure or sudden dizziness), the participant can be treated appropriately. More importantly, if you do experience an unpleasant side effect and don’t want to participate anymore, or simply decide you’re no longer interested in participating, you are free to leave the trial. You won’t be held down or tied to a bed! Participants have no legal obligation to remain in trails and all confidential participant information (such as names, addresses, health conditions) is kept private.
Participant safety is a priority at CCCT and in properly conducted clinical trials. In fact, researchers themselves may advise you to leave a trial if they believe it isn’t working out for you. If you are considering participating in a clinical trial it is important to know what your rights are and it may be helpful to ask the following questions:
- Is this trial registered with Health Canada or the Food and Drug Administration (FDA, the American equivalent of Health Canada)? How have the protocols for this trial been reviewed for safety?
- When was this treatment previously tested? What were the results? Benefits? Side-effects or adverse effects?
- Who will be in charge of my care?
- How many visits are there?
- Will I be obligated to remain in the trial until it is over? (The answer to this should always be no).
And importantly, make sure that when you sign a consent form, you are 100% clear on what the purpose of the trial is and what the risks and benefits are. If you are unclear about something, you should be given the opportunity to ask questions until you understand. This is known as informed consent. Keep in mind that informed consent is not a contract to participate in a trial and you are not signing away your life. It is simply to ensure you are informed.
CCCT wishes you and your loved ones all the best. Have a happy and safe Patient Safety Week.
For more information on patient safety please visit:
The Patient Safety Institute at: