Clinical Studies
What are clinical studies?
A clinical study is a study that is conducted in a clinical setting. It aims to evaluate a medical practice, drug or device. A clinical study is the primary way we test their safety and effectiveness.
Studies in Canada are reviewed and follow stringent guidelines to ensure the safety of the participants. There is a safety committee supervising the study that can end it early if there are any safety concerns.
Each study has a prespecified number of participants and a protocol procedures that aim to answers the researcher questions. The study ends when these are completed. Therefore, the duration of the research study can vary greatly. Many studies take years to be completed, because:
- The study aims to asses participants for long time
- The study may need 100s or even 1000s of participants.
- The study can start and end at different times at different study centers.
After the study ends the research sponsor will review and analyze the data and then write a report with the study results.
How do medications get approved for the public?
Medications follow a rigorous process before getting approved for the public.
Even before clinical research happens new medical drugs get tested on animal models. From those, only a few get selected to be used in clinical research.
Clinical research has four phases. During each phase there are usually a few research studies preformed to helps us ensure the safety and effectiveness of the medication.
In Phase 1, the goal is to see how much of the drug people should get, the side effects, and the safety of the drug.
This phase involves 20-80 participants.
In Phase 2, the goal is to see how well the drug works, it’s efficacy, and to keep testing its safety.
This phase involves 100-300 participants.
In Phase 3, we are making sure the drug is as safe and effective as the results from Phase 2 studies indicate.
This involves 100s or 1000s of participants, which allows us more complete results then in Phase 2.
After a medication has been approved for the public, Phase 4 research can happen. The goal in Phase 4 studies is to keep checking that it is safe and effective.
The number of participants in Phase 4 studies can vary depending on it’s goal.
Who is involved in a clinical study?
Participants – these are the people who are participating in the study
Sponsor – this organization plans, funds and collaborates with study centers to do the study
Study doctor (or Principle Investigator) – this person is in charge of the study at a study center
Study coordinator – this person runs the study at a study center
Review committee – this group of research experts review the study to keep participants safe
A study center is a location at which a study is being conducted. In order to get enough data, studies must be run at many study centers.
What are blinded studies?
In clinical research it is common to divide participants in to two groups. One group receives the medication and the other receive a placebo.
If participants don’t know which group they’re in, it’s a single blinded study.
When neither researchers nor participants know which participants get the drug and which get a placebo, it’s a double blinded study.
At the end of a blinded study everyone is made aware of who received the drug and who received a placebo.
A placebo is a pill, capsule, or liquid that looks like the study drug, but that doesn’t have any medication in it.
Researchers can compare how both groups respond and determine how efficient and safe the drug is.
Additionally, the results from blinded studies are more valuable, because they lack biased results.
- If you’re a participant, knowing whether or not you got the drug can change how you feel and what you tell the researchers.
- If you’re a researcher, knowing who got the drug can change how you compare patients and how you record results.
How to get involved
If you or someone you care about might be a good candidate for our clinical studies, speak to their primary care provider to be referred to U-Breathe for:
1. An assessment
2. Optimization of care
3. Enrollment in the clinical trial