title: Interim analyses of data as they accumulate in laboratory experimentation.
abstract: BACKGROUND
  Techniques for interim analysis, the statistical analysis of results while they are still accumulating, are highly-developed in the setting of clinical trials. But in the setting of laboratory experiments such analyses are usually conducted secretly and with no provisions for the necessary adjustments of the Type I error-rate.
  
  
  CONCLUSIONS
  Laboratory researchers, from ignorance or by design, often analyse their results before the final number of experimental units (humans, animals, tissues or cells) has been reached. If this is done in an uncontrolled fashion, the pejorative term 'peeking' has been applied. A statistical penalty must be exacted. This is because if enough interim analyses are conducted, and if the outcome of the trial is on the borderline between 'significant' and 'not significant', ultimately one of the analyses will result in the magical P = 0.05. I suggest that Armitage's technique of matched-pairs sequential analysis should be considered. The conditions for using this technique are ideal: almost unlimited opportunity for matched pairing, and a short time between commencement of a study and its completion. Both the Type I and Type II error-rates are controlled. And the maximum number of pairs necessary to achieve an outcome, whether P = 0.05 or P > 0.05, can be estimated in advance.
  
  
  CONCLUSIONS
  Laboratory investigators, if they are to be honest, must adjust the critical value of P if they analyse their data repeatedly. I suggest they should consider employing matched-pairs sequential analysis in designing their experiments.
authors.affiliation: Department of Surgery, The University of Melbourne, Parkville, Victoria, Australia. ludbrook@bigpond.net.au
authors.forename: John
authors.initials: J
authors.lastname: Ludbrook
mesh_terms: D032761:Animal Experimentation / Q000706:statistics & numerical data; D000818:Animals; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D016001:Confidence Intervals; D003627:Data Interpretation, Statistical; D006805:Human Experimentation / Q000706:statistics & numerical data; D006801:Humans; D011446:Prospective Studies; D012107:Research Design / Q000706:statistics & numerical data