Abstract
One of the main problems encountered in drawing conclusions from clinical trials is the wide variability in the methods used to assess treatment efficacy. In addition, it is often difficult to put the results of a study in their proper perspective due to the large differences between trials with respect to the patient population studied and variations in the definition and evaluation of end points and toxicity. When reporting the results of treatment, it is recommended to indicate [1, 2]:
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The total number of patients randomized or registered, irrespective of eligibility or evaluability.
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The total number of patients randomized or registered who are eligible and treated, regardless of the amount of treatment they received.
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The total number of patients randomized or registered, eligible, and adequately treated according to the protocol (so-called “fully evaluable”).
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© 1987 Martinus Nijhoff Publishing, Boston
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Staquet, M.J., Suciu, S., Sylvester, R. (1987). Analysis of Clinical Trial Data. In: Muggia, F.M., Rozencweig, M. (eds) Clinical Evaluation of Antitumor Therapy. Developments in Oncology, vol 46. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-2317-4_10
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DOI: https://doi.org/10.1007/978-1-4613-2317-4_10
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