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Analysis & Expressing Resultd in Clinical Trials

Analysis & Expressing Resultd in Clinical Trials. Type of Comparisons. Trials to Show Superiority Trials to Show Eqivalance or Non-inferiority Trials to Show Dose-Response Relationship (Dose Finding Trials) . Analysis of results. Base line Data Analysis Outcome Data Analysis

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Analysis & Expressing Resultd in Clinical Trials

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  1. Analysis & Expressing Resultd in Clinical Trials Dr. Khalili

  2. Type of Comparisons • Trials to Show Superiority • Trials to Show Eqivalance or Non-inferiority • Trials to Show Dose-Response Relationship (Dose Finding Trials) Dr. Khalili

  3. Analysis of results • Baseline Data Analysis • Outcome Data Analysis • Continious Data • Binary Data • Survival Data Dr. Khalili

  4. Baseline Data Analysis • To: • Check generalizability • Check comparability of treatment groups • The variables should be considered: • The characteristics of the disease (type, severity, duration, …) • Prognostic variables • Other coincidence diseases • Previous treatments • Use of statistical tests! Dr. Khalili

  5. Outcom Analysis • Continious Data: • Outcome analysis • Change score analysis • Analysis of Covariance (ANCOVA) • Binary Data • Absolute Risk Difference (ARD) • Number needed to Treatment (NNT) • Risk Ratio (RR) or Odds Ratio (OR) • Adjusting for baseline covariates using logistic models Dr. Khalili

  6. Protocol Deviation • Patient ineligible • Wrong treatment • Competing events • Noncompliance • Loss to follow up • Missing data Dr. Khalili

  7. Protocol Deviation • Approaches for analysis: • Intention to Treat • Per Protocol • Adheres only • As treated Dr. Khalili

  8. Per-protocol Analysis • A ‘per-protocol’ analysis excludes all patients who are known not to have completed the trial as planned. • Drop-outs • Non-compliers • Poor compliers • Falsely included Dr. Khalili

  9. Intention to Treat • An ‘intention to treat’ analysis actually analyses patients according to the treatment the trialist intended for them. • Thus, a patient assigned to the active treatment, but who confessed to not taking it, would nevertheless be analyzed as if she had received the active treatment. • Sometimes this is described as, ‘if randomized then analyzed’ Dr. Khalili

  10. Intention to Treat (ITT) • To keep randomization effective • To evaluate effectiveness not efficacy • Considered for pragmatic RCT • Should be checked with the “Best” case and “worst” case analyses • Decreases the power of study Dr. Khalili

  11. Intention To Treat Vs Per-Protocol 1 2 3 4 Dr. Khalili

  12. Some issues in multiple comparisons • Multiple treatments • Multiple outcomes • Repeated measures • Interim analyses • Subgroups analyses Dr. Khalili

  13. So much difficulty in research but we can do that. Dr. Khalili

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