Clinical trials are a way to determine if a new medication or device is safe and effective to treat a specific medical condition. Your participation allows you to try the newest medication for your condition while aiding researchers in the development of new treatment and medical procedures, potentially benefiting you, your family and other patients. The work completed here has resulted in U.S. Food and Drug Administration approval of new treatments for patients.
With your collaboration, we provide our sponsors and other clinical research organizations with high-quality, FDA-compliant research while also providing patients with professional, cutting-edge care to enhance the health and well-being of our community.
Participation in research is a voluntary and personal decision. At Bozeman Health Clinical Research, our top priority is patient safety.
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 groups of people 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, how effective it is, or its best use.
How am I protected while participating in clinical trials?
Each clinical trial is approved for public use by an Institutional Review Board (IRB), which is a group 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 patient privacy 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 site.
What are the benefits of participating in a clinical trial?
As a participant, you 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 you, and you may receive travel compensation.
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?
Before entering a study, volunteers are asked to consider all aspects of participation and encouraged to ask questions in order to have a clear understanding of what occurs. You can withdraw from a study at any time. Please tell the research group about your decision and the reason for withdrawal.
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.