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. Medical devices. 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. 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. Phase I trials are the first trials to involve people. Before clinical trials, tests and treatments are assessed in preclinical research. Observational Studies and Interventional Trials; Phases involved in Drug Clinical Trials; What are the steps involved in a study? Steps To Become a Clinical Trial Investigator. 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. For example, the research may aim to learn if a device is harmful to living tissue. Become an Investigator: Process. 3 Steps To Get A Virtual Clinical Trial Up And Running . Clinical trials are usually conducted in phases that build on one another. (Preclinical studies in petri dishes and animals already have been done.) Guidance documents accessible from this page represent the Agency's current thinking on good clinical practice (GCP) and the conduct of clinical trials. What are the steps involved in a study? The time for bold change within clinical trials is now. Clinical trials involving new drugs are conducted in a series of sequential steps, called phases to determine the safety and tolerability of the new drug and the efficacy against the target disease(s). Each phase is designed to answer a separate research question and is a separate clinical trial. Perhaps you were approached by your doctor, nurse or other Health Care Professional about a clinical trial … By Tyler Reynolds and Nadeem Fazal, PA Consulting. 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. If a new treatment is successful in one phase, it will proceed to further testing in the next phase. Clinical trial phases. The entire process of moving a drug from design to clinical trials takes 10 to 12 years on average. Participate in a Trial Become Clinical Trial Investigator Process. Phase I trials: Is it safe? 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