Literature DB >> 11520848

Monitoring clinical trials--interim data should be publicly available.

R J Lilford1, D Braunholtz, S Edwards, A Stevens.   

Abstract

Keywords:  Biomedical and Behavioral Research

Mesh：

Year:  2001        PMID： 11520848      PMCID： PMC1121037          DOI： 10.1136/bmj.323.7310.441

Source DB:  PubMed          Journal:  BMJ        ISSN： 0959-8138


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  19 in total

1.  A decision-theoretic evaluation of early stopping rules.

Authors:  D F Heitjan; P S Houts; H A Harvey
Journal:  Stat Med       Date:  1992-03       Impact factor: 2.373

2.  Policies for study monitoring and interim reporting of results.

Authors:  S J Green; T R Fleming; J R O'Fallon
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3.  Equipoise and the ethics of randomization.

Authors:  R J Lilford; J Jackson
Journal:  J R Soc Med       Date:  1995-10       Impact factor: 5.344

4.  Stopping rules for clinical trials incorporating clinical opinion.

Authors:  L S Freedman; D Lowe; P Macaskill
Journal:  Biometrics       Date:  1984-09       Impact factor: 2.571

5.  Stopping a clinical trial early: frequentist and Bayesian approaches applied to a CALGB trial in non-small-cell lung cancer.

Authors:  S L George; C Li; D A Berry; M R Green
Journal:  Stat Med       Date:  1994 Jul 15-30       Impact factor: 2.373

6.  Data Monitoring Committees and early stopping guidelines: the Southwest Oncology Group experience.

Authors:  J Crowley; S Green; P Y Liu; M Wolf
Journal:  Stat Med       Date:  1994 Jul 15-30       Impact factor: 2.373

7.  Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction.

Authors: 
Journal:  N Engl J Med       Date:  1989-08-10       Impact factor: 91.245

8.  Quality control in data monitoring of clinical trials.

Authors:  M De Pauw
Journal:  Acta Urol Belg       Date:  1994-04

9.  Early stopping rules--clinical perspectives and ethical considerations.

Authors:  M Baum; J Houghton; K Abrams
Journal:  Stat Med       Date:  1994 Jul 15-30       Impact factor: 2.373

10.  Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group.

Authors: 
Journal:  Lancet       Date:  1988-08-13       Impact factor: 79.321
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  7 in total

1.  Monitoring clinical trials. Dissemination of decisions on interim analyses needs wider debate.

Authors:  S M Bird
Journal:  BMJ       Date:  2001-12-15

2.  Should sponsors and DSMBs share interim results across trials?

Authors:  Seema K Shah; Liza Dawson; Dennis O Dixon; Reidar K Lie
Journal:  J Acquir Immune Defic Syndr       Date:  2011-12-15       Impact factor: 3.731

Review 3.  A primer on data safety monitoring boards: mission, methods, and controversies.

Authors:  Lisa K Hicks; Andreas Laupacis; Arthur S Slutsky
Journal:  Intensive Care Med       Date:  2007-07-28       Impact factor: 17.440

4.  Maintaining confidentiality of interim data to enhance trial integrity and credibility.

Authors:  Thomas R Fleming; Katrina Sharples; John McCall; Andrew Moore; Anthony Rodgers; Ralph Stewart
Journal:  Clin Trials       Date:  2008       Impact factor: 2.486

5.  Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients.

Authors:  Erzsebet Bartha; Thomas Davidson; Thor-Henrik Brodtkorb; Per Carlsson; Sigridur Kalman
Journal:  Trials       Date:  2013-07-09       Impact factor: 2.279

Review 6.  Sharing interim trial results by the Data Safety Monitoring Board with those responsible for the trial's conduct and progress: a narrative review.

Authors:  Victoria Borg Debono; Lawrence Mbuagbaw; Lehana Thabane
Journal:  Trials       Date:  2017-03-09       Impact factor: 2.279

Review 7.  Data sharing among data monitoring committees and responsibilities to patients and science.

Authors:  Iain Chalmers; Douglas G Altman; Hazel McHaffie; Nancy Owens; Richard W I Cooke
Journal:  Trials       Date:  2013-04-19       Impact factor: 2.279
  7 in total

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