In Clinical Trials: What You Need to Know, Part One, we discussed types of trials which are conducted as biomedical or health-related research studies in human beings. These trials, including interventional studies and observational studies, are designed to follow a pre-defined protocol.
A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study.
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 and more information is gained about an experimental treatment, its risks and how well it may or may not work.
Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, 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.
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Clinical Trials: What You Need to Know, Part 2 - Phases and Protocols
Also, it is important to understand that trials are not a substitute for treatment, but are merely for the purpose of collecting data. A common misconception spread by some sites is that clinical trials provide medical care, and this is simply not true. With that being said, clinical trials can be a great way to earn some extra money, see what medications may work better for you as opposed to what is already available, and the chance to receive excellent medical attention (not care). Good summary! dan@theclinicaltrialsguru.com
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