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 on humans.
Who can be involved in a clinical trial?
Any person with the condition being studied who meets all of the study specific criteria can volunteer to participate in a trial. Every trial has very specific 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 Diabetes Center 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 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?
If you are interested in helping the medical team at Rocky Mountain Diabetes Center investigate new medications, please visit our Current Studies page and review the studies. If you don’t find a current study for which you qualify, fill out the Future Study Participation Form, and we will be happy to provide information about upcoming clinical trials that might be right for your participation. Feel free to call or email if you have questions anytime.
Should you choose to participate in a clinical trial, please understand that our mutual commitment to the completion of the trial is critical. The very success of clinical trials hinges on completion.
Please consider joining Rocky Mountain Diabetes Center in being a part of the cure.
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.
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 on humans.
Any person with the condition being studied who meets all of the study specific criteria can volunteer to participate in a trial. Every trial has very specific 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 Diabetes Center always maintains strict confidentiality regarding information about individuals who participate in clinical trials.
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 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.
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.
