Bozeman Health Clinical Research David King, MD Medical Director, Bozeman Health Clinical Research Lu Anne Odt, BSN, RN Director, Bozeman Health Clinical Research

WHO ARE WE? Bozeman Health Clinical Research is the research arm of Bozeman Health Previously Clinical Research Group of Montana

WHY DO WE DO CLINICAL RESEARCH? To evaluate potential new medications, treatments and preventions for medical diseases in all therapeutic areas To answer specific health questions To develop safe and better medicine To discover new ways to improve health To advance medical knowledge Safety Is Our Top Priority Protocol, safety data, risks and benefits are carefully reviewed Potential to offer benefits to participants (subjects) Straight-forward clinical trials Acceptance of participants that can safely participate

WHAT IS PRECLINICAL RESEARCH? Development of drug Laboratory testing Investigational New Drug Application

WHAT HAPPENS IN CLINICAL RESEARCH? Clinical research evaluates a study drug in a real clinical setting Four phases in clinical research

Phase I First studies in healthy human volunteers 20 – 100 participants Study duration is months to 1 year Safety, dosing and identification of side effects Unblinded Bozeman Health Clinical Research does not participate in Phase I clinical trials

Phase II Involves 100’s of individuals with disease being studied First humans exposed to study drug Study duration is months – 2 years Gathers more safety data, efficacy of drug, side effects and optimal dosing for future clinical trials Compares study drug to standard treatment currently on the market and/or placebo (inactive substance with no treatment value) Drug is randomly assigned to participants Single or double blinded Drug packaging for blinded study Bozeman Health Clinical Research participates in Phase II clinical trials

Phase III Larger number of participants with the disease (300-3000) Multicenter trials Confirmation of safety and effectiveness of study drug Further monitoring of side effects Comparison of study drug to standard treatment currently on the market and/or placebo Drug is randomly assigned to participants Double blinded Determination of drug’s value in clinical practice Duration of study 1 – 4 years The most expensive, time consuming and difficult trials New Drug Application Bozeman Health Clinical Research participates in Phase III clinical trials

Phase IV Medication is approved and on the market Post marketing studies collect additional information including benefits, risks and optimal use of drug in broader population Bozeman Health Clinical Research participates in Phase IV clinical trials

WHO PROVIDES OVERSIGHT OF CLINICAL TRIALS? Federally regulated by Food and Drug Administration (FDA) Authority over drug and device studies Sites are subject to FDA regulations and audits Requires potential participants to be given complete information Informed Consent Form Voluntary process Explanation in non-technical terms Benefits of new therapy Known side effects Alternative treatments Discussion of study in detail, exchange of information and opportunity to ask questions Must be signed by both parties Institutional Review Boards (IRB) Independent committee consisting of a mix of medical, non-medical, scientific, non-scientific people including the lay public Supervision and monitoring of all clinical trials Protection of rights and welfare of human research subjects Competent review of all protocols May approve, require modifications and disapprove Advise on all aspects of welfare and safety Ensure scientific soundness of proposal Sponsor Appointment of competent investigators to participate in clinical trials All research staff trained Experience Previous audits and outcome Safety tests performed Side effects tracked

WHY PARTICIPATE IN CLINICAL TRIALS? Advance medicine Participation in trial may allow access to treatment otherwise not available Education – during study visits subjects receive attention and information for their specific disease Study medical care and study related supplies may be provided by study sponsor at no cost May be compensation for time and travel

ARE THERE DOWNSIDES TO BEING IN A STUDY? Investigational treatment may have unknown side effects Investigational treatment is not always better than current treatment Investigational treatment may help others but not you Investigator or participant may not know which treatment is being dispensed Subject may need to make more visits to the clinic Important to discuss concerns prior to enrolling in a clinical trial

IS WITHDRAWING FROM A RESEARCH STUDY POSSIBLE? You can withdraw at any time Tell research team you wish to withdraw Return study drug and study supplies that were previously dispensed

SHOULD YOU CONTINUE OFFICE VISITS WITH EXISTING DOCTORS? Clinical trials only address the condition being studied Encouraged to continue seeing your doctor(s)

WHAT ARE THE CURRENT STUDIES WE ARE CONDUCTING? Asthma Clostridium difficile (“C. diff”) Congestive heart failure Eosinophilic esophagitis Influenza

ARE YOU CONSIDERING PARTICIPATING IN A CLINICAL TRIAL? Know the purpose of the study. Does the trial involve a placebo or investigational treatment that is already on the market? How will the investigational treatment be given? How long will the trial last? What will you be asked to do? What has already been learned about the study drug – both the benefits and the risks? Do you have to pay for any part of the trial and/or will you be reimbursed for time and travel? What are the credentials and research experience of the investigators and staff?

THE IMPORTANCE OF CLINICAL RESEARCH Clinical trials can offer hope for many people and the opportunity to assist investigators in uncovering better treatments. It’s your involvement that helps investigators discover valuable ways to prevent, diagnose, treat and understand disease.

David King, MD Medical Director, Bozeman Health Clinical Research Lu Anne Odt, BSN, RN Director, Bozeman Health Clinical Research 406-414-4475 | clinicalresearch@bozemanhealth.org bozemanhealth.org/Bozeman-Health-Services/Clinical-Research