DEPARTMENTS

Clinical Research

CONTACT THIS DEPARTMENT

Great Falls Clinic Specialty Center
3000 15th Avenue South
Great Falls, MT 59405
(406) 454-2171

Clinical Research Coordinators:
Anna Bowman, Lead CRC: (406) 771-3373
Jessie Hall, CRC: (406) 268-3957


DEPARTMENT HOURS

Monday through Friday, 8:00 am to 5:00 pm

LOCATIONS

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.

 

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.

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.

Benefits:

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.

Risks:

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


20170625 (Vesalius): Phase III

Treating: Coronary Heart Disease
Investigator(s): PI: Dr. Libby Lake, Sub-I: Ellen Sparks, PA-C

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 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


I8F-MC-GPGN (SURPASS-CVOT): Phase III

Investigator(s): PI: Dr. Libby Lake, Sub-I: McKinley Hallfrisch, PA-C

Studying: The effect of Tirzepatide vs. Dulaglutide on major cardiovascular events in patients with Type 2 diabetes.
Status: Open/Currently Enrolling


D169CC00001 (Deliver-HF): Phase III

Treating: Heart Failure
Investigator(s): PI: Dr. Jorge Castriz, Sub-I: Ellen Sparks, PA-C

Status: Open/Currently Not Enrolling
An international, double-blind, randomized, placebo-controlled phase III study to evaluate the effect of Dapagliflozin on reducing CV death or worsening heart failure in patient with heart failure with preserved ejection fraction (HFpEF)


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


CAIN457H2315: Phase III

Treating: Axial Spondyloarthritis
Investigator(s): PI: Dr. Libby Lake, Sub-I: Dr. Karl Guter

Indication: Active non-radiographic Axial Spondyloarthritis

Status: Open/Currently Not Enrolling
A randomized, double-blind, placebo-controlled multicenter study of secukinumab to evaluate the safety, tolerability and efficacy up to 2 years in patients with active nonradiographic axial spondyloarthritis


CAIN457K2340: Phase III

Treating: Axial Spondyloarthritis
Investigator(s): PI: Dr. Karl Guter, Sub-I: Dr. Libby Lake
Indication: Active radiographic Axial Spondyloarthritis

Status: Open/Currently Not Enrolling
A randomized, partially-blinded, active-controlled multicenter study of secukinumab to demonstrate reduction of radiographic progression versus GP2017 (adalimumab biosimilar) at 104 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active ankylosing spondylitis


EFC14828 (Amplitude-O): Phase III

Treating: Diabetes
Investigator(s): PI: Dr. Thomas Warr, Sub-I: Dr. Libby Lake
Status: Open/Currently Not Enrolling
A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the effect of Efpeglenatide on cardiovascular outcomes in type 2 diabetes patients at high cardiovascular risk