Frequently Asked Questions
Please check if your question is listed below before contacting us.
1What is a Clinical Trial?
A clinical trial is a professionally designed research study done by volunteers who receive investigational treatments under supervision of a qualified physician to evaluate efficacy, safety and potential side effects of the investigational product for the indication. All research studies are review by an ethics review board and regulatory authorities such as Health Canada and the FDA.
2What Kinds of Studies are Available?
There are many different clinical studies available, these can be found at: www.clinicaltrials.gov
3Do I Always Receive Study Medications
Clinical Research Trials are often what we called double blinded. This means that neither the researchers or the patients know whether they are on study medication or placebo (sugar pill). This eliminates experimenter bias and protects the validity of the trial. In some cases, the subject is guaranteed to be on active medication.
4Do I Get Paid to be Involved in a Study?
In Canada research participants do not receive payments for taking part in a clinical trial. However, given the costs and expenses that come with joining a clinical trial. Clinical trial sponsor’s will often provide a stipend to help cover expenses as a reimbursement. The amount varies from study to study.
5What is Expected of Me?
Your safety is important to us, if you decide to take part in a clinical trial we ask that if you should experience any side effects that you report them immediately. We ask that you make every effort possible to show up for every visit as it is important for your safety and for trial data.
6Can My Family Doctor Be Involved?
Yes! We will communicate with your family doctor throughout the trial at your request. We may also request medical records from your current family physician. In some cases, throughout the trial we may forward lab results or equivalent if requested.
7How Do I Know if I'm Eligible for a Clinical Trial
We undergo a rigorous process prior to performing any study related procedures. Study participants will undergo a process called informed consent in which we explain the study in detail and answer any questions. After the study is adequately explained and all questions have been answered to your satisfaction you will sign and be given a copy of the informed consent. This just states that you understand the trial and that you give us permission to conduct study procedures. As a volunteer your rights are the most important part of a clinical trial. An informed consent is not a contract and you may withdraw your participation at any time from a clinical trial. After signing consent, we go through a screening process in which you are not on active medication until it is determined that you are eligible for the clinical trial.
8What is Informed Consent?
All clinical trials undergo a process prior to performing any study related procedures called informed consent. During this process the study is explained in detail by a health care professional who will answer any questions the participant may have. Signing informed consent acknowledges you understand the trial and that you give us permission to conduct study procedures.
9What If I Change My Mind?
Participants are always volunteers, and may withdraw consent at any time for any reason.
10Do I Receive a Copy of my Study Results?
The sponsor will publish data related to the clinical trial. While it is not the norm to receive a copy of the trial results. Interested participants may view published trial results.
11What Happens at the End of the Trial?
After a trial is complete a number of things may happen. A patient may enter an extension trial in which they continue receiving the medication. Often if the disease is debilitating the sponsor may keep the extension trial ongoing until the medication is approved for prescription or until no therapeutic benefit is demonstrated. In cases where there is no extension trial many sponsors have programs that may provide the medication free on a case by case basis. The last and most unlikely option is that there are no options provided by the sponsor in which case no follow up treatment is issued. In any case follow up visits are always conducted to ensure safety.