We understand that you may have questions before making your decision to volunteer for our clinical trials. Here are some questions and answers to help you make an informed decision.
Why should I participate in a study?
There are many rewarding reasons why you should volunteer to become a study participant. By participating in a clinical trial, you are contributing to the future of healthcare as well as potentially improving the quality of life for people around the world. In addition, you also will be compensated for your time.
Is it safe to participate?
There is always a risk when participating in clinical trials. Most of Winnipeg’s trials are considered minimal risk studies, which means there would be no more risk than if you bought a new product off the shelf you have never tried in the past. We do everything we can to minimize risk, starting with making sure our study participants are the right fit for each trial. This involves initial screening, and of course, we count on our participants to be completely honest when giving their medical histories. Our facilities are built specifically to accommodate clinical trials by offering a safe environment with licensed medical professionals who oversee studies throughout the duration of the program.
Are studies regulated?
All studies conducted by Cliantha Research adhere to the safety guidelines issued by Health Canada and other global regulatory agencies. In addition, clinical trial protocols are reviewed and approved by an Ethics committee or Institutional Review Board. This committee ensures that participants are not put in undue risk and that the research organization has proper safety measures.
Are there any age restrictions?
Each study is different and is dependent on the inclusion and exclusion criteria. Please always check with the Recruiting Department for your eligibility.
What happens in clinical studies?
We conduct many studies that look at a prototype and marketed products for their reaction and effectiveness, in healthy individuals, and in those who may have conditions that require a treatment similar to what is being tested. We also run studies that are to test prototype and marketed medical devices for their irritation, sensitization, and effectiveness. Rest assured, this is done in a very safe and controlled environment. During some trials, different types of tests will be done, including blood and urine tests, and use of various bioinstrumentations. But since each trial is different, you will get a full explanation before participation.
What are the durations of the trials?
Study duration of trials all depend on the study. Some studies require you to stay for just the day. Others may involve a weekend or consecutive visits in the same day. Others may simply be a take home study with various short evening visits. This information is always provided to you before committing to participation.
What can I expect from the facilities?
Depending on what type of study is conducted, the number of participants can be anywhere from a small group to as many as 200 volunteers. All participants have access to the facility WIFI, however, cell phone usage must be stopped during certain periods throughout the trial due to the sensitive nature of the bioinstrumentations. The waiting room has a television set, which will be used to play movies or shows during longer study visits that do not require you to acclimate.
Will meals be served?
Dependent on trial needs, meals or snacks may be served.
Can I withdraw from a study even after it starts?
You have the freedom of leaving at any point during the study. However, you will only be compensated for the time you participated in the study.
How often can I be a study participant?
For safety reasons, many studies require you to have “washout period” of a minimum of 28 days after the end of a study before volunteering for another one within the same body part. This washout period allows your body to rid itself of any remaining investigational drugs. However, there are always differing study requirement, so please check with the Recruiting Department for your eligibility.
What are some other questions I may want to ask?
What is the main reason for the study?
What is the compensation based on?
Will I be provided with an ROE or T4 for participation?
How much research and trial experience does your company have?
What happens if I cannot complete the study?
Will my participation be anonymous?
What if I have food or other allergies?