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CLINICAL TRIALS
What is the purpose of a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted, clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
Where do the ideas for trials come from?
Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more information is gained about an experimental treatment, such as its risks and how well it may or may not work.
Who sponsors clinical trials?
Clinical trials are sponsored by a variety of organizations or individuals such as physicians, medical institutions, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.
What are the different phases of clinical trials?
Each phase of a trial has a different purpose and helps researchers answer various questions:
In Phase I trials, researchers test a experimental drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range and reach a maximum tolerated dose (MTD), and identify side effects.
In Phase II trials, the experimental study drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase III trials, the experimental study drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects and compare it to commonly used treatments. This information will be used to determine if the experimental treatment can be used safely.
What happens during a clinical trial?
The clinical trial team may include doctors and nurses as well as other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, and monitor the participant carefully during and after the trial. Clinical trial participation is most successful when the protocol is carefully followed. The participant should contact the clinical trial team if they have any questions or concerns during and after the trial.
What is a protocol?
A protocol is a study plan that is designed for a particular clinical trial. It describes what types of people are able to participate in a trial; what type and how much of the drug will be given to participants along with side effects; a list of tests and procedures that are to be performed while on the trial; how long participants are expected to be in the trial. Participants on trial will follow this given protocol and monitored closely by the research staff.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. The research team will provide an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Potential benefits and any known risks are explained in the informed consent document. The participant then decides whether or not to sign the document. Once signed, a copy of this document will be given to the participant for their own reference. The informed consent document is not a contract, and the participant may withdraw from the trial at any time.
Where can I find out more about clinical trials?
For more information about clinical trials, please visit the ClinicalTrials.gov website at:
Source: based on www.clinicaltrials.gov |
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