Literature DB >> 26718676

Challenging Issues in Clinical Trial Design: Part 4 of a 4-Part Series on Statistics for Clinical Trials.

Stuart J Pocock1, Tim C Clayton2, Gregg W Stone3.   

Abstract

As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring Committees (including when to stop a trial early), and the role of adaptive designs. All topics are illustrated by relevant examples from cardiology trials.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Keywords:  Data Monitoring Committees; adaptive designs; factorial designs; noninferiority trials; randomized controlled trials as topic; statistical stopping guidelines; strategy trials

Mesh:

Year:  2015        PMID: 26718676     DOI: 10.1016/j.jacc.2015.10.051

Source DB:  PubMed          Journal:  J Am Coll Cardiol        ISSN: 0735-1097            Impact factor:   24.094


  12 in total

1.  The Adaptive designs CONSORT Extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Authors:  Munyaradzi Dimairo; Philip Pallmann; James Wason; Susan Todd; Thomas Jaki; Steven A Julious; Adrian P Mander; Christopher J Weir; Franz Koenig; Marc K Walton; Jon P Nicholl; Elizabeth Coates; Katie Biggs; Toshimitsu Hamasaki; Michael A Proschan; John A Scott; Yuki Ando; Daniel Hind; Douglas G Altman
Journal:  BMJ       Date:  2020-06-17

2.  Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial.

Authors:  Gregory Ducrocq; Jose R Gonzalez-Juanatey; Etienne Puymirat; Gilles Lemesle; Marine Cachanado; Isabelle Durand-Zaleski; Joan Albert Arnaiz; Manuel Martínez-Sellés; Johanne Silvain; Albert Ariza-Solé; Emile Ferrari; Gonzalo Calvo; Nicolas Danchin; Cristina Avendaño-Solá; Jerome Frenkiel; Alexandra Rousseau; Eric Vicaut; Tabassome Simon; Philippe Gabriel Steg
Journal:  JAMA       Date:  2021-02-09       Impact factor: 56.272

3.  FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial.

Authors:  Annastazia E Learoyd; Adnan Tufail; Catey Bunce; Pearse A Keane; Ashleigh Kernohan; Emily Robinson; Alijazy Jaber; Saqlain Sadiq; Robert Harper; John Lawrenson; Luke Vale; Heather Waterman; Abdel Douiri; Konstantinos Balaskas
Journal:  BMJ Open       Date:  2021-05-11       Impact factor: 2.692

4.  Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.

Authors:  M A Oyama; S S Ellenberg; P A Shaw
Journal:  J Vet Intern Med       Date:  2017-05-30       Impact factor: 3.333

5.  Traditional and Web-Based Technologies to Improve Partner Notification Following Syphilis Diagnosis Among Men Who Have Sex With Men in Lima, Peru: Pilot Randomized Controlled Trial.

Authors:  Jesse L Clark; Eddy R Segura; Catherine E Oldenburg; Hector J Salvatierra; Jessica Rios; Amaya Gabriela Perez-Brumer; Pedro Gonzales; Bhupendra Sheoran; Jorge Sanchez; Javier R Lama
Journal:  J Med Internet Res       Date:  2018-07-03       Impact factor: 5.428

Review 6.  Joint UK societies' 2019 consensus statement on renal denervation.

Authors:  Melvin D Lobo; Andrew S P Sharp; Vikas Kapil; Justin Davies; Mark A de Belder; Trevor Cleveland; Clare Bent; Neil Chapman; Indranil Dasgupta; Terry Levy; Anthony Mathur; Matthew Matson; Manish Saxena; Francesco P Cappuccio
Journal:  Heart       Date:  2019-07-10       Impact factor: 5.994

Review 7.  Endothelial shear stress enhancements: a potential solution for critically ill Covid-19 patients.

Authors:  Sayed Nour
Journal:  Biomed Eng Online       Date:  2020-12-03       Impact factor: 2.819

8.  The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Authors:  Munyaradzi Dimairo; Philip Pallmann; James Wason; Susan Todd; Thomas Jaki; Steven A Julious; Adrian P Mander; Christopher J Weir; Franz Koenig; Marc K Walton; Jon P Nicholl; Elizabeth Coates; Katie Biggs; Toshimitsu Hamasaki; Michael A Proschan; John A Scott; Yuki Ando; Daniel Hind; Douglas G Altman
Journal:  Trials       Date:  2020-06-17       Impact factor: 2.279

9.  Measurement of Symptom Change Following Web-Based Psychotherapy: Statistical Characteristics and Analytical Methods for Measuring and Interpreting Change.

Authors:  Eyal Karin; Blake F Dear; Gillian Z Heller; Milena Gandy; Nickolai Titov
Journal:  JMIR Ment Health       Date:  2018-07-12

10.  Proceedings from the 3rd European Clinical Consensus Conference for clinical trials in device-based hypertension therapies.

Authors:  Felix Mahfoud; Michel Azizi; Sebastian Ewen; Atul Pathak; Christian Ukena; Peter J Blankestijn; Michael Böhm; Michel Burnier; Gilles Chatellier; Isabelle Durand Zaleski; Guido Grassi; Michael Joner; David E Kandzari; Ajay Kirtane; Sverre E Kjeldsen; Melvin D Lobo; Thomas F Lüscher; John William McEvoy; Gianfranco Parati; Patrick Rossignol; Luis Ruilope; Markus P Schlaich; Atif Shahzad; Faisal Sharif; Andrew S P Sharp; Horst Sievert; Massimo Volpe; Michael A Weber; Roland E Schmieder; Costas Tsioufis; William Wijns
Journal:  Eur Heart J       Date:  2020-04-21       Impact factor: 29.983

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