Clinical trials are conducted in a series of four steps or phases. Steps To Become a Clinical Trial Investigator. During the early phases (phases 1 and 2), researchers figure out whether a new treatment is safe, what its side effects are, and the best dose of the new treatment. It assesses the features of a test or treatment. Phase 4 Clinical Trial/Post-Market Surveillance/Report Adverse Events: 0.5 to 10 years (at least as long as the drug is on the market) 1: 1 Specific Phase 4 trials are optional and can be of variable length if assigned by the FDA as a requirement for a treatment’s approval. Phase I trials: Is it safe? What are the steps involved in a study? If a new treatment is successful in one phase, it will proceed to further testing in the next phase. Become an Investigator: Process. Phase I trials are the first trials to involve people. Knowing the phase of the clinical trial is important because it can give you some idea about how much is known about the treatment being studied. Medical devices. Preclinical studies. Participate in a Trial Become Clinical Trial Investigator Process. Each phase is designed to answer a separate research question and is a separate clinical trial. By Tyler Reynolds and Nadeem Fazal, PA Consulting. Perhaps you were approached by your doctor, nurse or other Health Care Professional about a clinical trial … Observational Studies and Interventional Trials; Phases involved in Drug Clinical Trials; What are the steps involved in a study? steps of a clinical trial The concept for a clinical trial starts with scientific research in a laboratory, where a potential new treatment is tested in cell and animal models. Before clinical trials, tests and treatments are assessed in preclinical research. (Preclinical studies in petri dishes and animals already have been done.) Clinical trial phases. 3 Steps To Get A Virtual Clinical Trial Up And Running . Let’s take a closer look at each stage to better understand what goes into early clinical development and preparation for approval of a drug. Preclinical research is not done with people. STEP 7: Ending the Study Please remember to keep the Department informed of all active IRBs, renewals, and when terminated. Each phase is designed to answer certain questions. The most promising potential new therapies then move into clinical trials and are tested in humans. A clinical trial is only done when there is good reason to believe that a new test or treatment may improve the care of patients. For example, the research may aim to learn if a device is harmful to living tissue. Clinical trials to test new cancer treatments involve a series of steps, called phases. Clinical trials are usually conducted in phases that build on one another. 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