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.
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.
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.
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.
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.
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).
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 firstname.lastname@example.org, or Linda Franklin, RN, CRC, at (406) 257-8992 ext. 2230 or email@example.com.
CLEAR: A lipid trial testing a novel oral agent for CV patients unable to tolerate statin doses to lower LDL. Once a day dosing, five-year study. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or firstname.lastname@example.org.
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 email@example.com.
PANTHEON: A systolic heart failure trial testing a novel oral agent for subjects already on standard of care therapy and have an EF <35. Phase 2, 28-week study. Contact Pat Keane-Richmond, RN, CCRC, at (406) 752-7636 or firstname.lastname@example.org.