Literature DB >> 26700838

Design of Major Randomized Trials: Part 3 of a 4-Part Series on Statistics for Clinical Trials.

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

Abstract

This paper provides practical guidance on the fundamentals of design for major randomized controlled trials. Topics covered include the choice of patients, choice of treatment and control groups, choice of primary and secondary endpoints, methods of randomization, appropriate use of blinding, and determination of trial size. Insights are made with reference to contemporary major trials in cardiology.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Entities:  

Keywords:  avoidance of bias; randomized controlled trial; sample size; selection of patients; study design; treatments and endpoints

Mesh：

Year:  2015        PMID： 26700838     DOI： 10.1016/j.jacc.2015.10.036

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


  11 in total

1.  Influenza immunization during pregnancy: toward a balanced assessment of safety evidence.

Authors:  Deshayne B Fell; Saad B Omer; Kathryn M Edwards
Journal:  Hum Vaccin Immunother       Date:  2019-04-22       Impact factor: 3.452

Review 2.  Drug-eluting stents versus bare-metal stents for acute coronary syndrome.

Authors:  Joshua Feinberg; Emil Eik Nielsen; Janette Greenhalgh; Juliet Hounsome; Naqash J Sethi; Sanam Safi; Christian Gluud; Janus C Jakobsen
Journal:  Cochrane Database Syst Rev       Date:  2017-08-23

3.  Clinical trials of stem cell-based therapies for pediatric diseases: a comprehensive analysis of trials registered on ClinicalTrials.gov and the ICTRP portal site.

Authors:  Yinwen Ji; Chuan Hu; Zuxing Chen; Ying Li; Jiayong Dai; Jin Zhang; Qiang Shu
Journal:  Stem Cell Res Ther       Date:  2022-07-15       Impact factor: 8.079

4.  Cardiovascular outcome trials in patients with chronic kidney disease: challenges associated with selection of patients and endpoints.

Authors:  Patrick Rossignol; Rajiv Agarwal; Bernard Canaud; Alan Charney; Gilles Chatellier; Jonathan C Craig; William C Cushman; Ronald T Gansevoort; Bengt Fellström; Dahlia Garza; Nicolas Guzman; Frank A Holtkamp; Gerard M London; Ziad A Massy; Alexandre Mebazaa; Peter G M Mol; Marc A Pfeffer; Yves Rosenberg; Luis M Ruilope; Jonathan Seltzer; Amil M Shah; Salim Shah; Bhupinder Singh; Bergur V Stefánsson; Norman Stockbridge; Wendy Gattis Stough; Kristian Thygesen; Michael Walsh; Christoph Wanner; David G Warnock; Christopher S Wilcox; Janet Wittes; Bertram Pitt; Aliza Thompson; Faiez Zannad
Journal:  Eur Heart J       Date:  2019-03-14       Impact factor: 29.983

5.  Higher versus lower fraction of inspired oxygen or targets of arterial oxygenation for adults admitted to the intensive care unit.

Authors:  Marija Barbateskovic; Olav L Schjørring; Sara Russo Krauss; Janus C Jakobsen; Christian S Meyhoff; Rikke M Dahl; Bodil S Rasmussen; Anders Perner; Jørn Wetterslev
Journal:  Cochrane Database Syst Rev       Date:  2019-11-27

6.  Cardiovascular Outcomes Trials in Type 2 Diabetes: Where Do We Go From Here? Reflections From a Diabetes Care Editors' Expert Forum.

Authors:  William T Cefalu; Sanjay Kaul; Hertzel C Gerstein; Rury R Holman; Bernard Zinman; Jay S Skyler; Jennifer B Green; John B Buse; Silvio E Inzucchi; Lawrence A Leiter; Itamar Raz; Julio Rosenstock; Matthew C Riddle
Journal:  Diabetes Care       Date:  2018-01       Impact factor: 19.112

7.  Assessment of Impact of Patient Recruitment Volume on Risk Profile, Outcomes, and Treatment Effect in a Randomized Trial of Ticagrelor Versus Prasugrel in Acute Coronary Syndromes.

Authors:  Gjin Ndrepepa; Franz-Josef Neumann; Maurizio Menichelli; Isabell Bernlochner; Gert Richardt; Jochen Wöhrle; Bernhard Witzenbichler; Katharina Mayer; Salvatore Cassese; Senta Gewalt; Erion Xhepa; Sebastian Kufner; Hendrik B Sager; Michael Joner; Tareq Ibrahim; Karl-Ludwig Laugwitz; Heribert Schunkert; Stefanie Schüpke; Adnan Kastrati
Journal:  J Am Heart Assoc       Date:  2021-11-15       Impact factor: 5.501

8.  Comprehensive Analysis of Clinical Trials Registration for Lupus Nephritis Therapy on ClinicalTrials.gov.

Authors:  Yanfang Gao; Yuhan Wang; Rongshan Li; Xiaoshuang Zhou
Journal:  Front Med (Lausanne)       Date:  2021-06-17

9.  Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection.

Authors:  Patrícia O Guimarães; Renato D Lopes; Susanna R Stevens; André Zimerman; Lisa Wruck; Stefan K James; Ghazala Haque; Roberto Rocha C V Giraldez; John H Alexander; Karen P Alexander
Journal:  J Am Heart Assoc       Date:  2017-04-24       Impact factor: 5.501

10.  Coronary artery bypass surgery plus medical therapy versus medical therapy alone for ischaemic heart disease: a protocol for a systematic review with meta-analysis and trial sequential analysis.

Authors:  Ulver Spangsberg Lorenzen; Katrine Bredahl Buggeskov; Emil Eik Nielsen; Naqash Javaid Sethi; Christian Lildal Carranza; Christian Gluud; Janus Christian Jakobsen
Journal:  Syst Rev       Date:  2019-10-28
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