Literature DB >> 24757049

A modest proposal for dropping poor arms in clinical trials.

Michael A Proschan1, Lori E Dodd.   

Abstract

This paper presents a simple procedure for clinical trials comparing several arms with control. Demand for streamlining the evaluation of new treatments has led to phase III clinical trials with more arms than would have been used in the past. In such a setting, it is reasonable that some arms may not perform as well as an active control. We introduce a simple procedure that takes advantage of negative results in some comparisons to lessen the required strength of evidence for other comparisons. We evaluate properties analytically and use them to support claims made about multi-arm multi-stage designs. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Entities:  

Keywords:  comparisons with control; estimation bias; family-wise error (FWE) rate; multi-arm multi-stage (MAMS) design; multiple comparisons; sequentially rejective methods

Mesh:

Substances:

Year:  2014        PMID: 24757049      PMCID: PMC4663989          DOI: 10.1002/sim.6169

Source DB:  PubMed          Journal:  Stat Med        ISSN: 0277-6715            Impact factor:   2.373


  9 in total

1.  Novel designs for multi-arm clinical trials with survival outcomes with an application in ovarian cancer.

Authors:  Patrick Royston; Mahesh K B Parmar; Wendi Qian
Journal:  Stat Med       Date:  2003-07-30       Impact factor: 2.373

2.  Innovative trial designs are practical solutions for improving the treatment of tuberculosis.

Authors:  Patrick P J Phillips; Stephen H Gillespie; Martin Boeree; Norbert Heinrich; Rob Aarnoutse; Tim McHugh; Michel Pletschette; Christian Lienhardt; Richard Hafner; Charles Mgone; Alimuddin Zumla; Andrew J Nunn; Michael Hoelscher
Journal:  J Infect Dis       Date:  2012-03-22       Impact factor: 5.226

3.  Powerful short-cuts for multiple testing procedures with special reference to gatekeeping strategies.

Authors:  Gerhard Hommel; Frank Bretz; Willi Maurer
Journal:  Stat Med       Date:  2007-09-30       Impact factor: 2.373

4.  A graphical approach to sequentially rejective multiple test procedures.

Authors:  Frank Bretz; Willi Maurer; Werner Brannath; Martin Posch
Journal:  Stat Med       Date:  2009-02-15       Impact factor: 2.373

5.  A recycling framework for the construction of Bonferroni-based multiple tests.

Authors:  C-F Burman; C Sonesson; O Guilbaud
Journal:  Stat Med       Date:  2009-02-28       Impact factor: 2.373

6.  Optimal design of multi-arm multi-stage trials.

Authors:  James M S Wason; Thomas Jaki
Journal:  Stat Med       Date:  2012-07-23       Impact factor: 2.373

7.  Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit.

Authors:  Patrick Royston; Friederike M-S Barthel; Mahesh Kb Parmar; Babak Choodari-Oskooei; Valerie Isham
Journal:  Trials       Date:  2011-03-18       Impact factor: 2.279

8.  Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial.

Authors:  Matthew R Sydes; Mahesh K B Parmar; Nicholas D James; Noel W Clarke; David P Dearnaley; Malcolm D Mason; Rachel C Morgan; Karen Sanders; Patrick Royston
Journal:  Trials       Date:  2009-06-11       Impact factor: 2.279

9.  Speeding up the evaluation of new agents in cancer.

Authors:  Mahesh K B Parmar; Friederike M-S Barthel; Matthew Sydes; Ruth Langley; Rick Kaplan; Elizabeth Eisenhauer; Mark Brady; Nicholas James; Michael A Bookman; Ann-Marie Swart; Wendi Qian; Patrick Royston
Journal:  J Natl Cancer Inst       Date:  2008-08-26       Impact factor: 13.506

  9 in total
  3 in total

1.  Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study.

Authors:  Lori E Dodd; Michael A Proschan; Jacqueline Neuhaus; Joseph S Koopmeiners; James Neaton; John D Beigel; Kevin Barrett; Henry Clifford Lane; Richard T Davey
Journal:  J Infect Dis       Date:  2016-02-11       Impact factor: 5.226

2.  Controlling the family-wise error rate in multi-arm, multi-stage trials.

Authors:  Luis A Crouch; Lori E Dodd; Michael A Proschan
Journal:  Clin Trials       Date:  2017-03-19       Impact factor: 2.486

3.  Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes.

Authors:  Daniel J Bratton; Mahesh K B Parmar; Patrick P J Phillips; Babak Choodari-Oskooei
Journal:  Trials       Date:  2016-07-02       Impact factor: 2.279

  3 in total

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