At Logan Health, we are dedicated to examining new ways to prevent, treat and detect disease by offering clinical trials to our patients. Patient participation in clinical trials plays a vital role in the advancement of new medical therapies and technologies and contributes to evidence-based changes in how we detect and treat diseases.
What are clinical research trials?
- Clinical trials examine new ways to prevent, treat and detect disease. This involves using new drugs or devices, or new indications for existing drugs or devices.
- Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes how the study will be conducted and who can participate. This ensures quality and integrity at each site so that the data captured is the same at each research site.
- Before agreeing to participate, ask questions so that you can understand and are comfortable with what happens during the study.
What are the benefits of participation?
- Clinical trials offer high-quality care. If you are in a controlled study and do not receive the new treatment being tested, you will receive the current standard of care 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.
- You have the chance to help others advance medical research and improve treatments.
What are the risks of participation?
- New treatments under study are not always better than, or even as good as, the current standard of care.
- New treatments may have side effects that doctors do not expect or that are worse than those of the current standard of care treatment.
- Even if a new treatment has benefits, it may not work for you. Even standard of care treatments, proven effective for many people, do not help everyone.
- Studies may require your time commitment and periodic trips to the study site.
How are volunteers protected?
- Participation in a clinical study is completely voluntary and you can withdraw from the study at any time.
- Federal rules and regulations are in place to help protect your welfare.
- Institutional review boards (IRBs) oversee all sites conducting clinical research. The IRB ensures trials are ethical and that your rights are being protected.
What are the costs of participating in a clinical trial?
- Study sponsors may pay for study-specific costs.
- Some study visits that are identified as usual standard of care and preapproved may be billed to your health insurance plan.
- Frequently the sponsor of the clinical trial provides a stipend payment to cover your time and/or travel expenses.
Institutional Review Board
Under FDA regulations, an institutional review board (IRB) is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval) or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (such as informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.
Summary of Logan Health IRB
I. Institutional Authority[1]
Logan Health, has established and maintains a Logan Health IRB that operates in accordance with applicable federal and state laws, Logan Health Policies regarding research[2], and the Logan Health IRB Handbook.
II. Purpose[3]
The purpose of the Logan Health IRB is to ensure the protection of human subjects/participants in research.
III. Principles
The Logan Health IRB is guided by the ethical principles set forth in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the “Belmont Report”), applicable federal and state laws and guidance, local standards and expectations, and this Handbook. These principles include:
- Respect for Persons – Respect for persons incorporates at least two ethical convictions: first, individuals should be treated as autonomous agents; and second, those persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.
- Beneficence – Persons are treated in an ethical manner, not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do no harm, and (2) maximize possible benefits and minimize possible harms.
- Justice – An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are:
- To each person an equal share;
- To each person according to individual need;
- To each person according to individual effort;
- To each person according to societal contribution; and,
- To each person according to merit.
[1] 21 CFR 56.109(a); 45 CFR 46.109(a)
[2] Institutional Review Board Policy (A107); Research (A201); and Disclosure of PHI for Research (A960)
[3] 21 CFR 56.101(a) and 56.102(g); 45 CFR 46.101(a) and 46.102(g)
IRB Member Training
- Each Logan Health IRB member shall have on file in the Logan Health IRB administrative offices a certification of completion of the U.S. Department of Health and Human Services (HHS) Belmont Report training program. If the member is professionally certified as an Logan Health IRB professional, clinical investigator, or as a clinical coordinator, he/she will not be required to complete the HHS Belmont Report training program as long as the certification is current.
- New Logan Health IRB members will attend a mandatory orientation to become familiar with the Logan Health IRB, duties of members and the history of the creation of the Logan Health IRB.
Contact the IRB
Institutional Review Board Coordinator
Logan Health Medical Center
310 Sunnyview Lane
Kalispell, MT 59901
(406) 858-6854
WKGRPIRB@logan.org
Open to Enrollment Studies
Hematology & Oncology (Cancer)
FREENOME – The VALLANIA STUDY (FRNM008)
A Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening. If you are newly diagnosed with any type of cancer, please contact our office.
Principal Investigator: Elise Anderes, MD
Contact Mandy Bartlett, RN, CCRC 406-607-8021 or abartlett@logan.org
Or Deptresearch@logan.org – 406-752-7363
Dilon MARGIN PROBE 2.0 Data Collection Protocol
Prospective, single arm, multi-center study, clinical case collection study to acquire Margin Probe data and refine the procedure and algorithm for cancer detection. For women over 18 years of age diagnosed with cancer and undergoing lumpectomy or partial mastectomy procedure.
Principal investigator: Melissa Kaptanian, MD
Contact: Mandy Bartlett, RN, CCRC 406-607-8021 or abartlett@logan.org
Or Deptresearch@logan.org – 406-752-7636
BREAST CANCER COLLABORATIVE REGISTRY
An investigator-initiated, multisite institutional, non-interventional trial sponsored by the University of Nebraska Medical Center. The registry is focused on the collection of detailed information about participants to help create a resource that will be helpful to researchers in future studies related to breast cancer. It is the hope that future research using information from this registry will lead to improved diagnosis, prevention, and treatment of breast cancers.
Principal investigator: Melissa Kaptanian, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-8021 or abartlett@logan.org
Or Deptresearch@logan.org – (406) 752-7636
MONTANA CANCER CONSORTIUM (NCORP)TRIALS
The Montana Cancer Consortium is an NCI Community Oncology Research Program (NCORP) that gives patients at Logan Health access to more than 100 clinical trials for various disease sites, including brain, breast, lung, gastrointestinal, genitourinary, gynecological, lymphomas, melanoma, multiple myeloma, and neuroendocrine diseases. These trials are sponsored by cooperative groups in the U.S. (i.e., ALLIANCE, ECOG-ACRIN, NRG, SWOG) and the National Cancer Institute (NCI). This includes treatment trials, cancer prevention trials, and cancer care delivery research (CCDR). For more information on the open trials available, visit www.mtcancer.org
Site Principal Investigator, Elise Anderes, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-8021 or abartlett@logan.org
Or Deptresearch@logan.org – (406) 752-7636
PrognomiQ APOLLO Study P-030101
Advanced Precision Observational Lung Living Outcomes: Lung cancer screening study
Site Principal Investigator, Bethany Weiler-Lisowski, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-8021 or abartlett@logan.org or Lex Oestmann, RN, CRC (406) 607-8017 or aoestmann@logan.org
Or Deptresearch@logan.org – (406) 752-7636
Cofactor Genomics PREDAPT-2
A multicenter cancer biospecimen collection study
Site Principal Investigator, Ryan Roop, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-8021 or abartlett@logan.org Or Deptresearch@logan.org – (406) 752-7636
Janssen/Parexel-HALO Study
A Post-authorization Safety Study to Evaluate the Incidence of and Risk Factors for Severe and Fatal Infusion-related Reactions in Participants Treated with Daratumumab (Intravenous or Subcutaneous)
Site Principal Investigator, Elise Anderes, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-8021 or abartlett@logan.org Or Deptresearch@logan.org – (406) 752-7636
Exact Sciences – 2021-05
Specimen Collection Study to evaluate biomarkers in subjects with cancer.
Site Principle Investigator, Elise Anderes, MD
Contact: Mandy Bartlett, RN, CCRC (406) 607-0821 or abartlett@logan.org Or
Deptresearch@logan.org – (406) 752-7636
Cardiology
HERMES-E6018-4915
Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation.
Principal Investigator: Eve Gillespie, MD, PhD
Contact: Deptresearch@logan.org – (406) 752-7636
Optimizer Smart Post-Approval Device Study CA_CP_307
A prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an Optimizer implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a reduced (HFrEF) or moderately reduced (HFmrEF) ejection fraction (25-45% inclusive). Patients will be followed for three years to evaluate the continued safety and efficacy of the device and improvement in quality of life.
Principal Investigator: Eve Gillespie, MD, PhD
Contact: Deptresearch@logan.org – (406) 752-7636
Endocrinology
J2A-MC-GZGS – Achieve-4
A Phase 3, Open-Label Study of Once Daily LY3502970 Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)
Principal Investigator: Alison Schneider, MD
Contact: Deptresearch@logan.org – (406) 607-8017
J2A-MC-GZGU – Achieve-3
A Phase 3, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Once Daily
Oral LY3502970 Compared with Oral Semaglutide in Adult Participants with Type 2 Diabetes and Inadequate Glycemic Control with Metformin (ACHIEVE-3)
Principal Investigator: Alison Schneider, MD
Contact: Deptresearch@logan.org – (406) 607-8017
Gastroenterology
Contact: DEPTresearch@logan.org – (406) 752-7636 for ongoing or upcoming clinical trials
Rheumatology
INSPIRE 1 – TILD-19-07
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Tildrakizumab in Anti-TNF Experienced Subjects with Active Psoriatic Arthritis I (INSPIRE 1)
Site Principal Investigator: Roger Diegel, MD
Contact: Jaime Wyatt, CCRC (406) 755-1460 or jwyatt@logan.org
Or DEPTresearch@logan.org – (406) 752-7636
APEX PSA – CNTO1959PSA3004
A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutanuously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active Psoriatic Arthristis. APEX
Site Principal Investigator: Roger Diegel, MD
Contact: Jaime Wyatt, CCRC (406) 755-1460 or jwyatt@logan.org
Or Deptresearch@logan.org – (406) 752-7636
ABBVIE – M23-699
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Moderately to Severely Active SLE
Site Principal Investigator: Roger Diegel, MD
Contact: Jaime Wyatt, CCRC (406) 755-1460 or jwyatt@logan.org
Or Deptresearch@logan.org – (406) 752-7636
ABBVIE – M23-700
A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Site Principal Investigator: Roger Diegel, MD
Contact: Jaime Wyatt, CCRC (406) 755-1460 or jwyatt@logan.org
Or Deptresearch@logan.org – (406) 752-7636
Meet the Researchers
Director
Melissa Edmister, BSN, RN, Service Line Director Research and Cancer Services
Coordinators
Mandy Bartlett, RN, BAN, CCRC Certified Clinical Research Nurse Coordinator
Lex Oestmann, RN-BSN, CRC, Clinical Research Nurse Coordinator
Joanne Smith, Research Program Coordinator
Jaime Wyatt, CCRC, CPT, RMA, Certified Clinical Research Coordinator
Zoe Glasser Breeding, CRC, Clinical Research Coordinator
Investigators
Elise Anderes, MD, Principal Investigator, Medical Oncology
Jonathan M. Brunson, MD, Principal Investigator, Cardiology
Roger J. Diegel, MD, Principal Investigator, Rheumatology
Eve Gillespie, MD, PhD, Principal Investigator, Cardiology
Nathaniel Hall, MD, Principal Investigator, Cardiology
Melissa Kaptanian, MD, Principal Investigator, Breast Surgery, Oncology
Bethany Weiler-Lisowski, MD, Principal Investigator, Pulmonology
Ryan Roop, MD, Principal Investigator, Medical Oncology
Alison Schneider, MD, Principal Investigator, Endocrinology
William Simpson, MD, Principal Investigator, Gastrointestinal
Peter Henning, DO, Sub-Investigator, Rheumatology
Meghan Duvall, APRN, Sub-Investigator, Rheumatology
Jeffrey Eshleman, MD, Sub-Investigator, Radiation Oncology
Alexis Harrison, MD, MS, Sub-Investigator, Cardiology
Justin Linam, MD, Sub-Investigator, Radiation Oncology
Jose Ness, MD, Sub-Investigator, Medical Oncology
Austine Siomos, MD, Sub-Investigator, Pediatric Cardiology
Peter Wagner, MD, Sub-Investigator, Medical Oncology
Abigale D. Donkin, PAC, Sub-Investigator, Cardiology
Contact Us
Research
350 Heritage Way
Kalispell, MT 59901
Phone: (406) 752-7636
Fax: (406) 752-7847
Email: DEPTresearch@logan.org