What are the Next Steps if I am Interested to Participate in the ENSURE Study?
There are other criteria that need to be fulfilled to be able to take part in the ENSURE study.
If you decide you want to join the ENSURE study and if your study doctor confirms that you could be a good match, you will be asked to visit the study clinic for a screening visit. During this visit, you will be asked to read the study information and sign an informed consent form before any procedures are performed.
Additional tests will be performed to determine if your qualify to participate in the study.
What Does It Mean to Participate in the ENSURE Study?
The ENSURE study includes 2 separate periods:
Main treatment period
Extended treatment period
Frequently Asked Questions
What is a clinical study?
Clinical studies explore whether a medicine, treatment, or device is safe and effective for humans.
Clinical studies are scientific studies in which new medicines and treatments are tested to make sure they are safe and effective for people to take and use. They are one of the most important steps in bringing new treatments to patients.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.
Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).
All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centres, voluntary groups, or health care providers.
Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
What are the phases of clinical research studies?
Clinical studies are conducted in different phases:
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and any side effects associated with long-term use.
What does it mean to participate?
Taking part in a clinical trial typically involves taking tests to ensure you are a match for the study. If you qualify, you will visit the clinic regularly to receive the drug or treatment. The study staff will monitor your progress and well-being.
Before taking part in a trial, you are informed about what it means to participate in the study, including how the study is conducted, how you are protected during the study and the risks and benefits of participating. You may choose to end your participation in the study at any time.
You should learn about the risks and benefits of any clinical trial before you agree to take part in a trial. Talk to your doctor about specific trials you’re interested in.