Better Health Clinical Research
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What is a clinical trial?

A clinical trial (also known as clinical research) is a research study in human volunteers to answer specific health questions. Clinical trials are the fastest and safest way to find new and improved treatments that work in people and ways to improve health. Clinical research studies test the efficacy and safety of investigational drugs and devices and provide information about dose levels and how the drug is metabolized by our bodies.  

 

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to investigational new treatments before they are widely available, and help others by contributing to medical research. Clinical trials are typically free of charge, and health insurance is not required or billed.

 

What happens during a clinical trial?

The clinical trial team includes doctors, nurses, research coordinators, as well as other healthcare professionals. They check the health of the participants at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch during and after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. This also ensures that a participant's health and progress are closely monitored while they are in a study.

 

How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, almost all clinical research is federally regulated with built-in safeguards to protect participants. The trial follows a carefully constructed and controlled protocol, which is a study plan detailing what researchers will do in the study. At the completion of a clinical trial (or sometimes as it progresses), researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies, such as the FDA. Individual participants' names are not mentioned in these reports. Data is referred to by a study number and/or initials.