Study Participants: 20 to 100 healthy volunteers or people with the disease/condition. Phase 4 studies are generally the safest type of clinical trial, because the treatment has already been studied for a long time, and might have already been used in many people. While most patients enrolling on a phase … Each phase helps answer different questions about the new treatment. The drug treatment is compared to commonly used treatments. Then, they decide: Who qualifies to participate (selection criteria), How many people will be part of the study, Whether there will be a control group and other ways to limit research bias, How the drug will be given to patients and at what dosage, What assessments will be conducted, when, and what data will be collected, How the data will be reviewed and analyzed. Doctors start by giving very low doses of the drug to a few patients. Every trial has a different set of criteria that determines who can participate in the study, but the stage of cancer doesn't necessarily match which clinical trial phase is a good fit. If approved, the new treatment often becomes a standard of care, and newer treatments must often be compared to it before being approved. If later trials fail to show the predicted clinical benefits, the FDA may retract its approval of the new medication. The FDA reviews the results from the clinical trials … Typically involving a few hundred patients, these studies aren't large enough to show whether the drug will be beneficial. } This continues until doctors find the dose that's most likely to work well. Study Participants: Up to several hundred people with the disease/condition. color: #999999; The drug is often tested among patients with a specific type of cancer. Clinical Research Phases. However, if a new drug is intended for use in cancer patients, researchers conduct Phase 1 studies in patients with that type of cancer. #arrow { These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. The response the doctors look for in patients depends on the goal of the treatment. You're never required to participate in all phases, and in most cases, you can join at any phase. When phase 3 clinical trials (or sometimes phase 2 trials) show a new drug is more effective and safer than the current standard treatment, a New Drug Application (NDA) is submitted to the Food and Drug Administration (FDA) for approval. Although the medicine has been tested in thousands of people, additional studies can help show more about the treatment, such as very long term side effects. Due to the larger number of participants and longer duration or phase III, rare and long-term side … Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. As long as clinical trials are thoughtfully designed, reflect what developers know about a product, safeguard participants, and otherwise meet Federal standards, FDA allows wide latitude in clinical trial design. [CDATA[/* >