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Kalispell Regional Healthcare

Glacier View Research Institute

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What is Glacier View Research Institute?

Glacier View Research Institute provides the support for clinical trials that offer access to new treatment options for patients in northwest Montana. The goal is to make the entire clinical trial process smooth from beginning to end by identifying appropriate clinical trials, principal investigator recruitment and training, contract and budget negotiation, site assessment regulatory affairs, research coordinator assignments, patient recruitment, data collection, quality assurance and compliance. All clinical research trials that utilize Kalispell Regional facilities and/or staff will be reviewed and approved by the Kalispell Regional Healthcare Institutional Review Board.

Glacier View Research Institute's mission is to offer cutting-edge treatment to patients in our community through clinical trials, while also benefiting society through advancement of health care.

Why research?

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: NIH: National Institutes of Health)

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 100-300 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?

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 cancer 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.

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.

Glossary of Research Terms

Adverse event An expected or unexpected occurrence that may or may not be related to the clinical trial drug or device.
Beneficence – Doing no harm, maximizing benefits while minimizing risks.
Clinical research – Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy.
Consent form – Contains all relevant study information explained in lay terms and documents the voluntary participation of a subject. Presented to and signed by the subject.
Declaration of Helsinki – Statement of ethical principles first published by the World Medical Association in 1967 to define rules for therapeutic and non-therapeutic research.
Good clinical practice International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Ensures that the data reported is credible and accurate and that the subject's rights and confidentiality are protected.
Inclusion criteria – A list of criteria that must be met by all study subjects.
Informed consent – Information exchange including subject recruitment materials, verbal instructions, written materials, questions and answer sessions, and signature documenting consent with date. Subjects are given the opportunity to choose involvement based on information, comprehension and voluntariness.
Institution – Location of research. Retains ultimate responsibility for human subject regulation compliance.
Institutional review board Reviews research and consent forms to determine if rights and welfare of subjects are protected.
Investigator - Conducts and directs study. Carries ultimate responsibility for research. Is referred to as the principle investigator when acting as the leader for an investigational team. Also referred to as clinical investigator by the FDA.
National Institutes of Health Agency within the Department of Health and Human Services that provides funding for research, conducts studies and funds multisite national studies.
Patient oriented research – Research conducted with human subjects (or on material of human origin) in which an investigator or colleague directly interacts with human subjects.
Protocol – Documentation of study objective, design, methods, statistical methods and organization. The term also includes amendments made to the original document.
Protocol amendment – Changes or clarifications made in writing to the original protocol.
Risk-benefit ratio – Risk to individual subject vs. potential benefits. Also called risk-benefit analysis.
Serious adverse event Any event that results in death, a life-threatening situation, hospitalization or prolonged hospitalization, disability, incapacity or a congenital anomaly/birth defect.
Standard operating procedure Detailed, written procedures for the uniform performance of a function.
Vulnerable subject – Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).

What cancer clinical trials are currently enrolling through Glacier View Research Institute?

Breast Cancer Collaborative Registry through the University of Nebraska Medical Center: A registry designed to facilitate rapid and uniform collection of critical information to be used in developing prevention and treatment strategies against breast cancer.

Incyte REVEAL: A registry study to observe patients with polycythemia vera.

Miraca-Hematologic Disorders: A registry study of blood diseases evaluating clinical outcomes of current treatments.

Montana Cancer Consortium Studies: Many studies are enrolling involving brain, breast, gastrointestinal (including pancreas), genitourinary (including prostate), gynecological, head and neck, leukemia, lung, lymphoma, melanoma and others.

For questions, contact:
Mandy Bartlett, RN, BAN, CCRC
Certified Clinical Research Coordinator
abartlett@krmc.org
Glacier View Research Institute-Cancer
Northwest Oncology & Hematology at The Rock Medical Office Building
350 Heritage Way, Suite 1100
Kalispell, MT 59901
Phone: (406) 752-8669
Fax: (406) 752-8924

What cardiology clinical trials are currently enrolling through Glacier View Research Institute?

ADAPT-HF: A study for patients needing new biventricular pacing for heart failure. Patients who need this device will be asked to participate. The device is not provided. We are studying whether a specific program in the device benefits the patients in terms of their heart failure symptoms. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or pkeane@krmc.org, or Linda Franklin, RN, CRC, at (406) 257-8992 or lfranklin@krmc.org.

ADVENT-HF: A study to assess the effects of adaptive servo ventilation (ASV) on survival and frequency of cardiovascular hospital admissions in patients with heart failure and sleep apnea. ASV is a device that delivers positive pressure to the airway using a face mask and is approved for the treatment of sleep apnea. Indications are heart failure patients with obstructive or central sleep apnea. Patients will be screened for sleep apnea if they have heart failure as determined by echocardiography at screening. Patients cannot already be using CPAP. For more information, contact Joanne Smith at (406) 752-7636.

ARTESIA: A study for patients with implanted devices which may record episodes of atrial fibrillation with durations of 6 minutes to 24 hours. Patients will be randomized to ASA or Apixaban, and monitored for 2 years. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or pkeane@krmc.org, or Linda Franklin, RN, CRC, at (406) 257-8992 ext. 2230 or lfranklin@krmc.org.

CHAMP HF: A registry for heart failure patients to measure standard of care practices across the U.S. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or pkeane@krmc.org, or Melissa Sutton, RN, at (406) 257-8992 ext. 2279 or msutton@krmc.org for more information.

OncoCyte: A lung cancer screening registry using biomarker testing for newly diagnosed lung nodules. Contact Ann Rigg, RN, at (406) 257-8992 ext. 2229 or arigg@krmc.org.

PARAGON: A study for heart failure patients recently hospitalized for heart failure. First in its class study medication or standard care medication will be provided, along with lab, ECG, echocardiography and study visits at no cost. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or pkeane@krmc.org, or Linda Franklin, RN, CCRC, at (406) 257-8992 ext. 2230 or lfranklin@krmc.org.

What endocrinology clinical trials are currently enrolling through Glacier View Research Institute?

Diabetes - Type 2

Aspire: The purpose of the Aspire study is to measure the change in A1C from baseline over a period of one year while subjects are wearing the Medtronic MiniMed 530G insulin pump.

Carmelina: The purpose of the Carmelina study is to look at the impact linagliptin has on cardiovascular and kidney disease in patients with type 2 diabetes when compared to placebo.

For questions, contact:
Laura Ward, RN, CCRC: lward@krmc.org
Magen Lefkowicz, CCRC: mlefkowicz@krmc.org
Brandy Anderson, Regulatory, CRC: band1@krmc.org
Phone: (406) 751-4171
Fax: (406) 751-0092
Glacier View Research Institute-Endocrinology
430 Windward Way, Suite 100
Kalispell, MT 59901

What current pain management clinical trials are available through Glacier View Research Institute?

A prospective study for chronic lumbar back pain associated with moderate degenerative disc disease is being evaluated. No date for enrollment of this study is available.

For questions, contact:
Jaime Wyatt, BS, CRC
jwyatt@krmc.org
Glacier View Research Institute-Rheumatology
195 Commons Loop, Suite F
Kalispell, MT 59901
Phone: (406) 755-1460
Fax: (406) 755-1462

What current rheumatology clinical trials are available through Glacier View Research Institute?

HGS1006-C1113 Systemic Lupus Erythematosus (SLE): A study to assess adverse events of special interest in adults with active SLE while receiving Benlysta (belimumab), which is currently on the market. We are looking for subjects that are ≥18 years, on an SLE treatment and no prior history of the use of Benlysta.

Pfizer A3921133: A study to evaluate the safety of Xeljanz at 5mg twice daily or 10mg twice daily, compared to Humira 40mg every other week, in subjects with rheumatoid arthritis.

For questions, contact:
Shawn Erickson, CCRC, Certified Clinical Research Coordinator: shawnerickson@krmc.org
Jaime Wyatt, BS, CRC: jwyatt@krmc.org
Glacier View Research Institute-Rheumatology
195 Commons Loop, Suite F
Kalispell, MT 59901
Phone: (406) 755-1460
Fax: (406) 755-1462