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

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

3. 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

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

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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

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

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

16. 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?

17. 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.

19. David King, MD Medical Director, Bozeman Health Clinical Research
Lu Anne Odt, BSN, RN
Director, Bozeman Health Clinical Research |
bozemanhealth.org/Bozeman-Health-Services/Clinical-Research