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  1. 1. By K.Sai sudha
  2. 2. Definition of clinical trial • Clinical trials are a set of tests in medical research and drug development that generate safety and efficacy data for health interventions in human beings. • Clinical trials are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. • Clinical Trials are “real world” applications of the Scientific Method. 2
  3. 3.  Treatment Trials  Prevention Trials  Diagnostic Trials  Screening Trials  Quality of Life Trials 3
  4. 4.  1. Preclinical (animal) testing.  2. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.  3. Phase 1 studies  4. Phase 2 studies  5. Phase 3 studies  6. The pre-NDA period, just before a new drug application (NDA) is submitted.  7. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.  FDA reviewers will approve the application or find it either "approvable" or "not approvable." 4
  5. 5. Phases of clinical trials 5
  6. 6. PHASE 0 CLINICAL TRIALS:  Human micro dosing studies  Exploratory IND studies by FDA  It is an important element of NEXT. It promises to shorten the timeline by upto 6-12 months  MICRO DOSE: Less than1/100 of the dose of a test substance calculated to yield pharmacological effect of the test substance with a max dose of <100 micrograms  Patients Typically very small numbers of patients are involved.  These are very early studies of the pharmacodynamic and pharmacokinetic properties of a potential drug in humans. 6
  7. 7. ADVANTAGES and LIMITATIONS: ADVANTAGES: Microdose is used so, ADE are less Short duration Inexpensive Useful in the discovery of endogenous biomarkers LIMITATIONS: Limited use of agents having Non linear PKs Agents having different kinetic characteristics between microdose and full dose are not evaluated by phase 0 trials. The laboratory parameters are very limited and expensive, researchers have to depend on BA/BE labs. 7
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  9. 9. Phase I trials •The aim of a Phase I trial is to determine the maximum tolerated dose (MTD) of the new treatment. The MTD is found by escalating the treatment dose until the dose-limiting toxicity (DLT) is reached. •20-25 healthy volunteers •Patients: Anticancer drugs, AIDS therapy •Duration: 6-12 months •No blinding 9
  10. 10. Phase I Standard 3 + 3 Design Dose DLT 3 pts 3 pts Recommended dose 3 pts 3 pts 3 pts Starting dose + 3 pts DLT 3 pts
  11. 11. Phase II • First in patients • Duration: 6 months to several years. • It acts as a screening stage. • To evaluate activity, safety and feasibility of the new treatment. 11
  12. 12.  Phase IIa  Phase IIb  EARLY PHASE  LATE PHASE  Pilot clinical trials  Pivotal clinical trials  20-200 PATIENTS  50-300 PATIENTS  SINGLE BLIND comparison  DOUBLE BLIND compared with with a standard drug a placebo or standard drug 12
  13. 13. Phase III • Large scale, Randomised, Controlled trials . Minimises errors of phases I and II. • To compare the new treatment against a suitable comparator. • Target population: several 100’s to 3000 patients. Takes a long time: up to 5 years 13
  14. 14. Phase III • Phase IIIa • Phase IIIb • Prior to NDA • After the NDA but prior to the approval and • Generates data on safety and efficacy in both controlled and uncontrolled trials. • Provides much of information for the package insert launch. • Period between submission and approval of a regulatory dossier for marketing authorization • These may supplement or complete the earlier trials or may be directed to Phase IV trials. 14
  15. 15.  No fixed duration / patient population  Starts immediately after marketing  These are primarily observational or non- experimental in nature.  Helps to detect rare ADRs, Drug interactions  Also new uses for drugs [Sometimes called Phase V]  Harmful effects discovered may result in a drug being no longer sold, or restricted to certain uses. 2010 2011 15
  16. 16. Summary of various phases 16
  17. 17.  Positive trial  Non-inferior trial  Inconclusive trial  Negative trial 17
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