Literature DB >> 19358221

Sample size re-estimation in clinical trials.

Michael A Proschan1.   

Abstract

Adaptive clinical trials are becoming very popular because of their flexibility in allowing mid-stream changes of sample size, endpoints, populations, etc. At the same time, they have been regarded with mistrust because they can produce bizarre results in very extreme settings. Understanding the advantages and disadvantages of these rapidly developing methods is a must. This paper reviews flexible methods for sample size re-estimation when the outcome is continuous.

Mesh:

Year:  2009        PMID: 19358221     DOI: 10.1002/bimj.200800266

Source DB:  PubMed          Journal:  Biom J        ISSN: 0323-3847            Impact factor:   2.207


  24 in total

1.  Present state and future challenges in pediatric abdominal pain therapeutics research: Looking beyond the forest.

Authors:  Craig A Friesen; Jennifer V Schurman; Susan M Abdel-Rahman
Journal:  World J Gastrointest Pharmacol Ther       Date:  2015-11-06

2.  SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

Authors:  An-Wen Chan; Jennifer M Tetzlaff; Peter C Gøtzsche; Douglas G Altman; Howard Mann; Jesse A Berlin; Kay Dickersin; Asbjørn Hróbjartsson; Kenneth F Schulz; Wendy R Parulekar; Karmela Krleza-Jeric; Andreas Laupacis; David Moher
Journal:  BMJ       Date:  2013-01-08

Review 3.  Essential statistical principles of clinical trials of pain treatments.

Authors:  Robert H Dworkin; Scott R Evans; Omar Mbowe; Michael P McDermott
Journal:  Pain Rep       Date:  2020-12-18

Review 4.  Trial designs for chemotherapy-induced peripheral neuropathy prevention: ACTTION recommendations.

Authors:  Jennifer S Gewandter; Joanna Brell; Guido Cavaletti; Patrick M Dougherty; Scott Evans; Lynn Howie; Michael P McDermott; Ann O'Mara; A Gordon Smith; Daniela Dastros-Pitei; Lynn R Gauthier; Simon Haroutounian; Matthew Jarpe; Nathaniel P Katz; Charles Loprinzi; Paul Richardson; Ellen M Lavoie-Smith; Patrick Y Wen; Dennis C Turk; Robert H Dworkin; Roy Freeman
Journal:  Neurology       Date:  2018-07-27       Impact factor: 9.910

5.  Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop.

Authors:  Christopher S Coffey; Bruce Levin; Christina Clark; Cate Timmerman; Janet Wittes; Peter Gilbert; Sara Harris
Journal:  Clin Trials       Date:  2012-12       Impact factor: 2.486

6.  A post hoc evaluation of a sample size re-estimation in the Secondary Prevention of Small Subcortical Strokes study.

Authors:  Leslie A McClure; Jeff M Szychowski; Oscar Benavente; Robert G Hart; Christopher S Coffey
Journal:  Clin Trials       Date:  2016-04-19       Impact factor: 2.486

7.  Double-blind parallel placebo-controlled study to evaluate the effect of molsidomine on the endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: the MEDCOR Trial.

Authors:  Emanuele Barbato; Arnold Herman; Edouard Benit; Luc Janssens; Jacques Lalmand; Etienne Hoffer; Patrick Chenu; Antoine Guédès; Luc Missault; Bruno Pirenne; François Cardinal; Steven Vercauteren; William Wijns
Journal:  J Cardiovasc Transl Res       Date:  2013-10-19       Impact factor: 4.132

8.  Sample size re-estimation in an on-going NIH-sponsored clinical trial: the secondary prevention of small subcortical strokes experience.

Authors:  Leslie A McClure; Jeff M Szychowski; Oscar Benavente; Christopher S Coffey
Journal:  Contemp Clin Trials       Date:  2012-06-30       Impact factor: 2.226

Review 9.  The future of clinical trials in urological oncology.

Authors:  Vikram M Narayan; Philipp Dahm
Journal:  Nat Rev Urol       Date:  2019-10-11       Impact factor: 14.432

10.  Maximum inflation of the type 1 error rate when sample size and allocation rate are adapted in a pre-planned interim look.

Authors:  Alexandra C Graf; Peter Bauer
Journal:  Stat Med       Date:  2011-04-15       Impact factor: 2.373

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