A Patient’s Guide to Clinical Trials
What is a clinical trial?
Before a new medication can be made available for physicians and other healthcare providers to prescribe to their patients, it must undergo very thorough testing in numerous clinical trials.
A clinical trial is a study designed to scrupulously test the effects of a new medication or a medical device on volunteer participants.
Clinical trials measure the ability of the medication or device to treat the condition for which it is intended, while closely monitoring its safety and possible side effects. Clinical trials are an important step in bringing new medications to the marketplace
When can a medication be tested?
When a pharmaceutical company has a new medication they would like to test in a clinical trial, a request is submitted by the company to the U.S. Food and Drug Administration (FDA).
Before the FDA grants permission to conduct a clinical trial, they will verify that the pharmaceutical company has already done extensive laboratory research regarding the new medication. Only then will the FDA allow a newly proposed medication to be tested with humans.
Who can be involved in a clinical trial?
Any person with the condition being and who meets all of the study criteria can volunteer to participate in a trial. Every trial has very particular requirements such as age, sex, weight, and a specific diagnosed medical condition.
The doctor overseeing the clinical trial reviews each potential participant’s medical history to determine if the person is eligible. Known side effects and potential risks, as well as all study procedures, will be thoroughly explained to potential participants by either the physician or the study coordinator prior to participation.
In addition, Rocky Mountain Clinical Research always maintains strict confidentiality regarding information about individuals who participate in clinical trials.
What is an Informed Consent Form?
The Informed Consent Form is designed to give the potential participant, or their legal representative, easy-to-understand information regarding all aspects of a specific clinical trial. It is designed to provide all the information needed to help a person decide if they want to participate in the clinical trial.
Adequate time is allowed to ask questions and to make sure the potential participant feels comfortable with and agrees to the terms of the clinical trial. No study-related procedures will be performed until the Informed Consent Form is signed by the participant. Each participant is given a copy of the Informed Consent Form.
What is an Institutional Review Board?
The Institutional Review Board (IRB) is a group of healthcare professionals that must review and approve the details of a clinical trial before it begins.
The primary responsibility of the IRB is to review all study-related activity and to protect the safety and rights of study participants.
How do I get involved in a clinical trial?
It is easy to get involved in a clinical trial. You may always ask your healthcare provider if you qualify for any current studies, or simply fill out the information request form found on each of the study pages, and someone from our team will reach out to you. If you prefer to call, do so anytime by dialing (208) 522-6005 during our office hours. For a complete list of direct phone numbers and email addresses, visit our Contact Us page.
As you consider participation, ask your healthcare provider how you can benefit. We look forward to joining forces with you to advance medical therapies and cures.
Meet the Physicians behind the Clinical Trials
Glossary of Clinical Trial Terms
- Primary Investigator
- The physician with the primary responsibility for the design and conduct of a research project or clinical trial.
- Clinical Trial
- A carefully designed study of the effects of medication, medical treatment, or a medical device on a group of volunteer “subjects.”
- Subject
- An individual who volunteers to participate in a clinical trial.
- Placebo
- A chemically neutral substance given under the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than the actual power of the drug.
- Double Blind
- When neither the investigator nor the subject knows which medication the subject will be receiving.
- Inclusion/ Exclusion Criteria
- The specific requirements such as age, medical history, weight, diagnosis, and laboratory values that determine if a subject can be included in a clinical trial.
