Chapter 7. Analysis and Interpretation of Phase III Trials

  1. Allan Hackshaw Deputy Director1,2

Published Online: 29 APR 2009

DOI: 10.1002/9781444311723.ch7

A Concise Guide to Clinical Trials

A Concise Guide to Clinical Trials

How to Cite

Hackshaw, A. (2009) Analysis and Interpretation of Phase III Trials, in A Concise Guide to Clinical Trials, Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781444311723.ch7

Author Information

  1. 1

    Cancer Research, UK

  2. 2

    UCL Cancer Trials Centre, UK

Publication History

  1. Published Online: 29 APR 2009
  2. Published Print: 10 APR 2009

ISBN Information

Print ISBN: 9781405167741

Online ISBN: 9781444311723

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Keywords:

  • effect size – single quantitative summary measure used to interpret clinical trial data;
  • number needed to treat (NNT);
  • multivariate linear regression;
  • confidence interval (CI);
  • disease-free survival (DFS);
  • statistical test

Summary

This chapter contains sections titled:

  • Outcome measures based on counting people

  • Outcome measures based on taking measurements on people

  • Outcome measures based on time-to-event data

  • Interpreting different types of phase III trials

  • More on confidence intervals

  • More on p-values

  • Relationship between confidence intervals, the no-effect value and p-values

  • Intention-to-treat and per-protocol analyses

  • Randomised subjects who are ineligible and subject withdrawals

  • Sub-group analyses

  • Safety, toxicity or adverse events

  • Interim analyses and stopping trials early

  • Clinical versus statistical significance: more on interpreting results

  • Summary

  • References

  • Appendix: Further introduction to p-values