Patient Education and Resources
To find more information about clinical studies, click the links below:
Bozeman Health Clinical Research Clinical Trials:Clinical Research Trials
Bozeman Health Cancer Center Clinical Trials:
Cancer Clinical Trials
Clinical Trials through the National Institutes of Health:
NIH Clinical Trials
Food and Drug Administration:
United States Department of Health and Human Services:
Frequently Asked Questions:
- What are the clinical trial phases?
Clinical trials are divided by the Food and Drug Administration (FDA) into
categories as described below:
Phase I: Clinical studies that are conducted with healthy volunteers to
emphasize the safety of a new drug or device.
Phase II: Clinical studies that gather preliminary data from a larger group
of volunteers with a specific medical condition to determine the effectiveness
of a product.
Phase III: Clinical studies that gather information from different populations
using different dosages of the drug to identify effectiveness and safety.
Phase IV: Clinical studies that occur after the FDA has approved a product
for the market, to gather information about a drug’s safety, efficacy,
or optimal use.
- How am I protected while participating in clinical trials
Each clinical trial is approved for suitability by an Institutional Review
Board (IRB), which is comprised of professionals from the fields of medicine,
religion, law, and education. The IRB’s function is to protect the
safety and rights of volunteers in clinical trials. Health Insurance Portability
and Accountability Act (HIPAA) regulations ensure privacy protections
for patients by protecting medical records and other individually identifiable
health information. Informed consent is a process in which the researchers
communicate all of the important information regarding a study to the
potential participant. This process ensures that individuals understand
the potential risks and benefits of a clinical trial, as well as alternatives
available for a specific condition. Enrollment in a clinical trial is
always voluntary, and an individual can leave a study at any time. For
further information about IRB, HIPAA, and Informed Consent, please visit
the United States Department of Health and Human Services (HHS) site above.
- What are the benefits of participating in a clinical trial?
Participants may have access to new treatments, medications, medical devices,
disease education, and the ability to advance medicine. The treatments
are usually provided at no cost to the volunteer. Participants may receive
- What are the disadvantages of participating in a clinical trial?
An investigational drug or device may cause side effects, and patients
may not always benefit from the treatment.
- What if I volunteer and later change my mind and no longer want to participate?
You can withdraw from a study at any time. We ask that you notify the research
group about your decision and the reason for withdrawal. Prior to entering
a study, volunteers are asked to consider all aspects of study participation
and to ask questions in order to have a clear understanding of what occurs
during study participation.
- If I am in a clinical trial, can I continue seeing my regular primary care provider?
You are encouraged to continue seeing your regular primary care provider.
Clinical trials only address the condition being studied and are not a
substitute for regular follow-up with your primary care provider.