Statistical considerations in the intent-to-treat principle.

  title={Statistical considerations in the intent-to-treat principle.},
  author={John M Lachin},
  journal={Controlled clinical trials},
  volume={21 3},
This paper describes some of the statistical considerations in the intent-to-treat design and analysis of clinical trials. The pivotal property of a clinical trial is the assignment of treatments to patients at random. Randomization alone, however, is not sufficient to provide an unbiased comparison of therapies. An additional requirement is that the set of patients contributing to an analysis provides an unbiased assessment of treatment effects, or that any missing data are ignorable. A… CONTINUE READING

From This Paper

Figures, tables, and topics from this paper.


Publications citing this paper.
Showing 1-10 of 207 extracted citations


Publications referenced by this paper.
Showing 1-10 of 58 references

A test of missing completely at random for multivariate data with missing values

  • Little RJA
  • J Am Stat Assoc
  • 1988
Highly Influential
5 Excerpts

Planning and Analysis of Observational Studies

  • WG Cochran
  • New York: Wiley;
  • 1983
Highly Influential
3 Excerpts

International Conference on Harmonization : Guidance on statistical principles for clinical trials

  • MJ Knapp, DS Knopman, PR Solomon
  • Federal Register
  • 1998

Similar Papers

Loading similar papers…