The Great Falls Clinic Clinical Research Department, in conjunction with Clinic providers, actively participate on a national level in clinical research studies, which allows patients in Great Falls and the surrounding area to participate in clinical trials that, at one time, were only offered in large cities. The clinical trials incorporate state-of-the-art patient care with the most recent breakthroughs in medicine.
View all Great Falls Clinic Open Research Studies.
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 regarding eligibility to participate. Some studies need volunteers with a certain disease, some need healthy individuals and others require men or women only.
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: NIH: National Institutes of Health)
Clinical research trials contribute to evidence-based medicine by helping find new and better ways to treat patients. The contribution that research makes plays a vital role in the advancement of medical therapies, medications and technologies. Without research, these advancements would not exist.
What are the phases of clinical trials?
Clinical research trials are conducted in phases.
Phase I – 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.
Phase II – An experimental drug or treatment is given to a group of between 100 and 300 people to see if it is effective and to further evaluate its safety.
Phase III – 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.
Phase IV – Post marketing 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.
ALL CURRENTLY OPEN RESEARCH STUDIES
National Cancer Institute Clinical Trials via the Montana Cancer Consortium
- There are more than 50 open trials for all different cancer types.
- Please reach out to your Oncologist to ask about a trial that may be open for you!
Caris Pharmatech Oncology Clinical Trials
- This small subset of trials is open to different tumor biomarkers for different cancer types.
- While these trials are more limited in their inclusion criteria, please reach out to your Oncologist to know if there is a trial open for you!
20170625 (Vesalius): Phase III
Treating: Coronary Heart Disease
Investigator(s): PI: Dr. Libby Lake
Indication: Reduce the risk of Coronary Heart Disease (CHD) death, myocardial infarction (MI), stroke, and ischemia-driven arterial revascularization in adults at high risk of cardiovascular events without prior MI or stroke
Status: Open/Currently Not Enrolling
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Rike Without Prior Myocardial Infarction or Stroke
ATB200-02: Phase I/II
Treating: Pompe Disease
Investigator(s): PI: Dr. Karl Guter, Sub-I: Dr. Thomas Warr
Indication: Pompe Disease
Status: Open/Currently Not Enrolling
An Open-Label, Fixed-Sequence, Ascending-Dose, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Intravenous Infusions of ATB200 Co-administered With Oral AT2221 in Adult Subjects With Pompe Disease