Dear all,
Here is a summary of the references I received with regard protocol
deviations.
1. Fergusson D, Aarron SP, Guyatt G, Herbert P (2002) Post-
randomization exclusions: the intention to treat principle and
excluding patients from analysis. BMJ Vol 325 652-654.
2. Lewis JA (1988) Statistical Standards for protocols and protocol
deviations. Recent results in cancer research. 111, 27-33.
3. Lewis JA & Machin D (1993) Intention to treat – who should use
ITT? Statistical issues in cancer research.
4. Newell D (1992) Intention-to-treat analysis: Implications for
Quantitative and Qualitative Research. International Journal of
Epidemiology. Vol 21, no. 5.
5. White I, Pocock S (1996) Statistical reporting of clinical trials
with individual changes from allocated treatment. Statistics in
Medicine. Vol 15, 249-262.
6. Frangakis C, Rubin D (1999) Addressing complications of intention-
to-treat analysis in the combined presence of all-or-none treatment-
noncompliance and subsequent missing outcomes. Biometrika 86, 365-
379.
7. Chapter 12 Protocol Deviations: Clinical Trials: A practical
Approach. Pocock S
Thank you very much to the following:
Robert Newcombe
Paul Brown
Sally Hollis
Thanks, Lucy.
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Hello statisticians!
I am looking for references/examples/personal experiences of protocol
deviations/violations in clinical trials.
I would particularly be interested in:
1. Different types of deviations/violations and reasons for and
against including these subjects in analysis.
2. Different ways you obtain information on deviations/violations in
clinical trials.
Thank you very much.
Have a good day!
Lucy.
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