What is clinical trails and elucidate its stages ?
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Clinical Trials are studies that have been designed by medical researchers to evaluate the safety and efficacy of drugs, vaccines, devices and other treatment strategies. Clinical trials can help identify new ways to prevent disease, test innovative new therapies and improve prevention and treatment options for patients with existing conditions. Phase I studies assess the safety of a drug or device. Phase II studies test the efficacy of a drug or device. Phase III studies involve randomized and blind testing in several hundred to several thousand patients. Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale.
Clinical trials are when a team of scientists and doctors tries a new medical treatment, drug, device, or method on a group of people to test how well it works. The purpose of a clinical trial is to find a new and improved way to treat, prevent, or diagnose different types of illness. The various phases are
Phase I: Doctors give a new treatment to a small number of people to test safety. The researchers find out the best way to give the new treatment, any possible side effects, and safe dosage.
Phase II: The research team tries to figure out how well the treatment works for a particular illness.
Phase III: The team compares the new treatment with the standard treatment and tries to examine the effects of different dosages and combinations of treatments on different populations (e.g., men, women, young, old, and various ethnic groups).
Phase IV: Here, the treatment is tried on average patients who agree to it. The goal is to look for side effects not found in prior phases and to figure out how well the treatment works over the long term. The FDA allows drugmakers to market the treatment during this phase.