14 Clinical Trials Frequently Asked Questions

4. What kind of clinical trials are there? The type of trial that most people read about and consider enrolling in is called an interventional trial. This tests treatments that are not yet approved for use. Prevention trials are designed to stop medical conditions from occurring. Observational trials are used to look at health issues in large groups of people and do not involve treatment. Diagnostic and screening trials are intended to detect and diagnose medical problems. 5. What are the phases of clinical trials? Developing a new medical treatment takes many years. The process is intended to best treat medical conditions without harming people. Before a medical treatment can even be tested in people, animal testing is absolutely required. As mentioned above, this phase is called pre-clinical testing. Animal testing is governed by three principals: 1) to reduce the use of animals to the minimum but still collect data indicating that the treatment is safe and effective in people, 2) minimize animal suffering and assure animal welfare as much as possible, 3) replace animal experiments with other alternatives when possible. Phase I testing is the first step in humans. The purpose is to determine safety and to evaluate side effects. Phase I studies also test how the drug is absorbed, distributed and eliminated from the body. Often people who do not have the disease (healthy individuals) participate in Phase I. The number of people involved at this stage is usually small. Phase II trials are sometimes divided into Phase IIA and Phase IIB. Sometimes these two sub-phases are combined. Phase II trials further assess dosing and are designed to determine the best drug dose to use and how much of a dose is safe. Phase II studies can also measure efficacy
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