fda clinical trial phases

In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study. See listed clinical studies related to the coronavirus disease (COVID-19) In Phase 2 studies, researchers administer the drug to a group of patients with the disease or condition for which the drug is being developed. content: "\f0dc"; 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. Clinical trials on humans can be divided into three main phases (literally, phase I, II and III). Each member has different responsibilities. At first, very few people receive the medicine being studied. /*-->