Literature DB >> 3567306

Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.

N L Geller, S J Pocock.   

Abstract

Recent developments in group sequential methods have had a great impact on the design and analysis of randomized clinical trials. The consequences for both planned and unplanned interim analyses are discussed using several real trials as illustrations. Guidelines for the conduct of interim analysis are given, including tables of nominal significance levels and required sample sizes for several group sequential plans. Areas in need of further theoretical advance include multiple endpoints, estimation of treatment differences, stratification, and design of multiple-armed trials.

Mesh：

Year:  1987        PMID： 3567306

Source DB:  PubMed          Journal:  Biometrics        ISSN： 0006-341X            Impact factor:   2.571


  17 in total

1.  When to stop a clinical trial.

Authors:  S J Pocock
Journal:  BMJ       Date:  1992-07-25

2.  CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.

Authors:  David Moher; Sally Hopewell; Kenneth F Schulz; Victor Montori; Peter C Gøtzsche; P J Devereaux; Diana Elbourne; Matthias Egger; Douglas G Altman
Journal:  BMJ       Date:  2010-03-23

3.  A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study.

Authors:  Loreto Gesualdo; Gérard London; Matthew Turner; Christopher Lee; Karen Macdonald; David Goldsmith; Adrian Covic; Philippe Zaoui; Christian Combe; Johannes Mann; Frank Dellanna; Michael Muenzberg; Ivo Abraham
Journal:  Intern Emerg Med       Date:  2011-05-18       Impact factor: 3.397

4.  Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma.

Authors:  Jérôme Fayette; Nicolas Penel; Christine Chevreau; Jean-Yves Blay; Didier Cupissol; Antoine Thyss; Cécile Guillemet; Maria Rios; Frédéric Rolland; Pierre Fargeot; Jacques Olivier Bay; Simone Mathoulin-Pelissier; Jean Michel Coindre; Binh Bui-Nguyen
Journal:  Invest New Drugs       Date:  2009-01-16       Impact factor: 3.850

5.  Arthrographic joint distension with saline and steroid improves function and reduces pain in patients with painful stiff shoulder: results of a randomised, double blind, placebo controlled trial.

Authors:  R Buchbinder; S Green; A Forbes; S Hall; G Lawler
Journal:  Ann Rheum Dis       Date:  2004-03       Impact factor: 19.103

Review 6.  Pressure and volume limited ventilation for the ventilatory management of patients with acute lung injury: a systematic review and meta-analysis.

Authors:  Karen E A Burns; Neill K J Adhikari; Arthur S Slutsky; Gordon H Guyatt; Jesus Villar; Haibo Zhang; Qi Zhou; Deborah J Cook; Thomas E Stewart; Maureen O Meade
Journal:  PLoS One       Date:  2011-01-28       Impact factor: 3.240

7.  Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice.

Authors: 
Journal:  Trials       Date:  2010-05-28       Impact factor: 2.279

8.  Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders.

Authors:  Andrew J Hahne; Jon J Ford; Luke D Surkitt; Matthew C Richards; Alexander Y P Chan; Sarah L Thompson; Rana S Hinman; Nicholas F Taylor
Journal:  BMC Musculoskelet Disord       Date:  2011-05-20       Impact factor: 2.362

9.  VITA-D: cholecalciferol substitution in vitamin D deficient kidney transplant recipients: a randomized, placebo-controlled study to evaluate the post-transplant outcome.

Authors:  Ursula Thiem; Georg Heinze; Rudolf Segel; Thomas Perkmann; Franz Kainberger; Ferdinand Mühlbacher; Walter Hörl; Kyra Borchhardt
Journal:  Trials       Date:  2009-05-29       Impact factor: 2.279

10.  Consolidative Radiotherapy for Limited Metastatic Non-Small-Cell Lung Cancer: A Phase 2 Randomized Clinical Trial.

Authors:  Puneeth Iyengar; Zabi Wardak; David E Gerber; Vasu Tumati; Chul Ahn; Randall S Hughes; Jonathan E Dowell; Naga Cheedella; Lucien Nedzi; Kenneth D Westover; Suprabha Pulipparacharuvil; Hak Choy; Robert D Timmerman
Journal:  JAMA Oncol       Date:  2018-01-11       Impact factor: 31.777
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