At Kalispell Regional Healthcare, clinical research is focused on improving treatments and diagnoses for patients. Clinical research trials contribute to evidence-based medicine by helping find new and better ways to treat patients. Research's contributions play a vital role in the advancement of medical therapies, medications and technologies. Without research, these advancements would not exist.
What are clinical trials?
Clinical trials are part of clinical research and the heart of all medical advances. Clinical trials examine new ways to prevent, treat and detect disease. This involves using new drugs or devices, or approved drugs or devices.
Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.
In the United States there are various committees, regulatory groups, rules and regulations (federal, state and local) that oversee clinical trials and, foremost, protect the safety of clinical trial participants
(Source: National Institutes of Health)
What are the phases of clinical trials?
Clinical research trials are conducted in phases.
An experimental drug or treatment is given to find a safe dose, to decide how the new treatment should be given or to see how the new treatment affects the human body. Usually 10-15 people participate in the clinical trial.
An experimental drug or treatment is given to a group of 100-300 people to see if it is effective and to further evaluate its safety.
An experimental drug or treatment is given to a larger group of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.
Postmarketing studies are conducted to evaluate risks, benefits and optimal use of the drug or treatment or a new indication for already approved drugs.
What are the benefits and risks of participating in clinical trials?
Clinical trials offer high-quality care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good as, or better than, the new approach.
- If a new treatment is proven to work and you are taking it, you may be among the first to benefit.
- By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
- You have the chance to help others and improve treatment.
New treatments under study are not always better than, or even as good as, standard care.
- If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach.
- New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.
- Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
What are the costs of participating in clinical trials?
There is no cost to the clinical trial participant. Frequently the sponsor of the clinical trial provides a stipend to participants for their time and/or travel expenses.
Do I need to be referred by a physician for a clinical trial?
No. However, you may request that your primary care physician be notified if you decide to participate in a clinical trial.
Glacier View Research Institute
Institutional Review Board