Abstract
Clinical trials tend to have a long duration, because mostly patients are enrolled one by one, and their responses to treatment are observed sequentially. For the organizers this part of the trial is an exciting phase because after all the hard work involved in planning and getting the trial started, finally concrete data will become available. Immediately, there is the possibility to look at the data in order to check that the trial protocol is pursued appropriately by the investigators and to look at any difficulties, e.g., those with patient and/or doctor compliance, and to see whether there is any need for protocol alterations (Pocock 1988a). “Looking at the data” for such purposes should, however, be done carefully. In this chapter we will discuss questions such as:
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Armitage P (1975) Sequential medical trials. Blackwell, Oxford
Demets DL, Ware JH (1980) Group sequential methods in clinical trials with a one-sided hypothesis. Biometrika 67:651–660
Department of Health and Human Services, Food and Drug Administration (1998) International conference on harmonisation; guidance on statistical principles for clinical trials availability. Fed Regist 63(179):49583–49598
Food and Drug Administration (1996) Guideline for industry. Structure and content of clinical study reports. FDA. At internet website WWW.DFA.GOV/CDER/REGGUIDE.HTM/GUIDANCEDOCUMENTS
Pocock SJ (1977) Group sequential methods in the design and analysis of clinical trials. Biometrika 64:191–199
Pocock SJ (1988a) Clinical trials. A practical approach. Wiley, New York, p 62
Pocock SJ (1988b) Clinical trials. A practical approach. Wiley, New York, p 147
Pocock SJ (1988c) Clinical trials. A practical approach. Wiley, New York, p 153
Pocock SJ (1988d) Clinical trials. A practical approach. Wiley, New York, p 149
Wald A (1947) Sequential analysis. Wiley, New York
Whitehead J (1983) The design and analysis of sequential clinical trials. Ellis Horwood publishers, Chichester
Whitehead J (1998) Planning and evaluating sequential trials (PEST, version 3). University of Reading, Reading. www.reading.ac.uk/mps/pest/pest.html
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Cleophas, T.J., Zwinderman, A.H. (2012). Interim Analyses. In: Statistics Applied to Clinical Studies. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-2863-9_7
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DOI: https://doi.org/10.1007/978-94-007-2863-9_7
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