Clinical Trial Phase 3 Studies
Phase 3 studies are expanded controlled and uncontrolled trials . They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include several hundred to several thousand people.
In both Phase 2 and 3, CDER can impose a clinical hold if a study is unsafe (as in Phase 1 ), or if the protocol is clearly deficient in design in meeting its stated objectives. Great care is taken to ensure that this determination is not made in isolation, but reflects current scientific knowledge, agency experience with the design of clinical trials, and experience with the class of drugs under investigation.
ICH guidelines and Good Clinical Practice (GCP)- Types and Phases of Clinical Trials - Role and responsibilities of Clinical Research coordinator - Principal Investigator - IRB
Requirements of the Clinical Trial Directive - key guidelines and documents - improving clinical trial application authorization - inspection
FDA acceptance of non-US clinical trials - Requirements for using clinical data from non-IND/IDE clinical trials - IND and/or marketing approval application
Start-Up Costs - Fixed Costs - Variable - hidden - overhead - qualifying trial and routine care - cost plan - negotiating a budget
