Kim Bolland
University of Reading
13 Papers
228 Citations
Kim Bolland is an academic researcher from University of Reading. The author has contributed to research in topics: Sample size determination & Interim analysis. The author has an hindex of 9, co-authored 13 publications.
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Papers
Mid-trial design reviews for sequential clinical trials.
TL;DR: This paper discusses mid-trial design reviews in the special cases of trials with a relatively short recruitment phase followed by a longer period of follow-up, and of normally distributed responses, and extensive simulations are reported demonstrating the validity of the review procedure.
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Sample size review in a head injury trial with ordered categorical responses.
TL;DR: Pre-trial simulations showing that the type I error rate would not be influenced and the power would be preserved will be presented, and the implementation of the procedure will be described.
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Formal approaches to safety monitoring of clinical trials in life-threatening conditions.
Kim Bolland,John Whitehead +1 more
TL;DR: A formal approach to safety monitoring, using a sequential safety procedure to aid the decisions made by the DSMB, designed to recommend termination of the study as soon as evidence that the experimental treatment is worse than the control in terms of the primary safety response is so strong that it is unethical to proceed.
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Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline.
TL;DR: The International Citicoline Trial in acUte Stroke is a sequential phase III study of the use of the drug citicoline in the treatment of acute ischaemic stroke, which was initiated in 2006 in 56 treatment centres.
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Cautionary tales of survival analysis: conflicting analyses from a clinical trial in breast cancer.
TL;DR: It is shown how checking whether hazards are proportional can help in avoiding erroneous conclusions and how analyses conducted at different times can demonstrate different effects.
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