Literature DB >> 29083951

Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review.

Toshimitsu Hamasaki1,2, Scott R Evans3, Koko Asakura1,2.   

Abstract

We review the design, data monitoring, and analyses of clinical trials with co-primary endpoints. Recently developed methods for fixed-sample and group-sequential settings are described. Practical considerations are discussed, and guidance for the application of these methods is provided.

Entities:  

Keywords:  Co-primary endpoints (CPE); fixed-sample designs; group-sequential designs; intersection–union test (IUT); multiple primary endpoints (MPE); type II error adjustment

Mesh：

Year:  2017        PMID： 29083951      PMCID： PMC6135538          DOI： 10.1080/10543406.2017.1378668

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN： 1054-3406            Impact factor:   1.051


  55 in total

1.  Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment.

Authors:  John Whitehead; Tatsuru Matsushita
Journal:  Stat Med       Date:  2003-03-15       Impact factor: 2.373

2.  Challenges to multiple testing in clinical trials.

Authors:  H M James Hung; Sue-Jane Wang
Journal:  Biom J       Date:  2010-12       Impact factor: 2.207

Review 3.  Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

Authors:  H M James Hung; Sue-Jane Wang; Peiling Yang; Kun Jin; John Lawrence; George Kordzakhia; Tristan Massie
Journal:  J Biopharm Stat       Date:  2016       Impact factor: 1.051

4.  Comparison of treatments in a combination therapy trial.

Authors:  H I Patel
Journal:  J Biopharm Stat       Date:  1991       Impact factor: 1.051

5.  Sample size determination in superiority clinical trials with multiple co-primary correlated endpoints.

Authors:  Takashi Sozu; Tomoyuki Sugimoto; Toshimitsu Hamasaki
Journal:  J Biopharm Stat       Date:  2011-07       Impact factor: 1.051

6.  Reducing unnecessary measurements in clinical trials with multiple primary endpoints.

Authors:  Takashi Sozu; Tomoyuki Sugimoto; Toshimitsu Hamasaki
Journal:  J Biopharm Stat       Date:  2015-06-22       Impact factor: 1.051

7.  Guidelines for monitoring efficacy and toxicity responses in clinical trials.

Authors:  R J Cook; V T Farewell
Journal:  Biometrics       Date:  1994-12       Impact factor: 2.571

Review 8.  Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health-care practitioners.

Authors:  Oliver Grundmann; Saunjoo L Yoon
Journal:  J Gastroenterol Hepatol       Date:  2010-01-13       Impact factor: 4.029

9.  Sample size determination for clinical trials with co-primary outcomes: exponential event times.

Authors:  Toshimitsu Hamasaki; Tomoyuki Sugimoto; Scott Evans; Takashi Sozu
Journal:  Pharm Stat       Date:  2012-10-19       Impact factor: 1.894

Review 10.  Adaptive designs for confirmatory clinical trials with subgroup selection.

Authors:  Nigel Stallard; Thomas Hamborg; Nicholas Parsons; Tim Friede
Journal:  J Biopharm Stat       Date:  2014       Impact factor: 1.051
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  5 in total

Review 1.  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 2.  Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.

Authors:  Pascale Nevins; Shelley Vanderhout; Kelly Carroll; Stuart G Nicholls; Seana N Semchishen; Jamie C Brehaut; Dean A Fergusson; Bruno Giraudeau; Monica Taljaard
Journal:  J Clin Epidemiol       Date:  2021-12-08       Impact factor: 7.407

3.  Interim Monitoring for Futility in Clinical Trials with Two Co-primary Endpoints Using Prediction.

Authors:  Koko Asakura; Scott R Evans; Toshimitsu Hamasaki
Journal:  Stat Biopharm Res       Date:  2019-11-04       Impact factor: 1.452

4.  Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

Authors:  Xiaoqian Liu; Sarah Robbins; Xia Wang; Sonika Virk; Karen Schuck; Leticia A Deveza; Win Min Oo; Kirsty Carmichael; Benny Antony; Felix Eckstein; Wolfgang Wirth; Christopher Little; James Linklater; Anthony Harris; David Humphries; R O'Connell; Gillian Heller; Thomas Buttel; Stefan Lohmander; Changhai Ding; David J Hunter
Journal:  BMJ Open       Date:  2021-11-29       Impact factor: 2.692

5.  Blinded sample size re-estimation in a comparative diagnostic accuracy study.

Authors:  Maria Stark; Mailin Hesse; Werner Brannath; Antonia Zapf
Journal:  BMC Med Res Methodol       Date:  2022-04-19       Impact factor: 4.612
  5 in total

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