Literature DB >> 17661013

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

Lisa K Hicks1, Andreas Laupacis, Arthur S Slutsky.   

Abstract

Mesh：

Year:  2007        PMID： 17661013     DOI： 10.1007/s00134-007-0794-9

Source DB:  PubMed          Journal:  Intensive Care Med        ISSN： 0342-4642            Impact factor:   17.440


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  17 in total

Review 1.  Monitoring clinical trials--interim data should be publicly available.

Authors:  R J Lilford; D Braunholtz; S Edwards; A Stevens
Journal:  BMJ       Date:  2001-08-25

2.  Trial design and patient safety--the debate continues.

Authors:  Robert Steinbrook
Journal:  N Engl J Med       Date:  2003-08-14       Impact factor: 91.245

3.  A major trial needs three statisticians: why, how and who?

Authors:  Stuart J Pocock
Journal:  Stat Med       Date:  2004-05-30       Impact factor: 2.373

4.  The role of the unblinded sponsor statistician.

Authors:  Steven Snapinn; Thomas Cook; Deborah Shapiro; Duane Snavely
Journal:  Stat Med       Date:  2004-05-30       Impact factor: 2.373

5.  Celecoxib for the prevention of colorectal adenomatous polyps.

Authors:  Nadir Arber; Craig J Eagle; Julius Spicak; István Rácz; Petr Dite; Jan Hajer; Miroslav Zavoral; Maria J Lechuga; Paola Gerletti; Jie Tang; Rebecca B Rosenstein; Katie Macdonald; Pritha Bhadra; Robert Fowler; Janet Wittes; Ann G Zauber; Scott D Solomon; Bernard Levin
Journal:  N Engl J Med       Date:  2006-08-31       Impact factor: 91.245

Review 6.  Stopping clinical trials by design.

Authors:  John Whitehead
Journal:  Nat Rev Drug Discov       Date:  2004-11       Impact factor: 84.694

Review 7.  Randomized trials stopped early for benefit: a systematic review.

Authors:  Victor M Montori; P J Devereaux; Neill K J Adhikari; Karen E A Burns; Christoph H Eggert; Matthias Briel; Christina Lacchetti; Teresa W Leung; Elizabeth Darling; Dianne M Bryant; Heiner C Bucher; Holger J Schünemann; Maureen O Meade; Deborah J Cook; Patricia J Erwin; Amit Sood; Richa Sood; Benjamin Lo; Carly A Thompson; Qi Zhou; Edward Mills; Gordon H Guyatt
Journal:  JAMA       Date:  2005-11-02       Impact factor: 56.272

8.  Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial.

Authors:  Robert S Bresalier; Robert S Sandler; Hui Quan; James A Bolognese; Bettina Oxenius; Kevin Horgan; Christopher Lines; Robert Riddell; Dion Morton; Angel Lanas; Marvin A Konstam; John A Baron
Journal:  N Engl J Med       Date:  2005-02-15       Impact factor: 91.245

9.  Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967.

Authors: 
Journal:  Control Clin Trials       Date:  1988-06

10.  Monitoring clinical trials: issues and controversies regarding confidentiality.

Authors:  Thomas R Fleming; Susan Ellenberg; David L DeMets
Journal:  Stat Med       Date:  2002-10-15       Impact factor: 2.373
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  5 in total

Review 1.  Year in review in Intensive Care Medicine, 2007. III. Ethics and legislation, health services research, pharmacology and toxicology, nutrition and paediatrics.

Authors:  Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Johan Groeneveld; Goran Hedenstierna; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Philipp Metnitz; Jerôme Pugin; Jan Wernerman; Haibo Zhang
Journal:  Intensive Care Med       Date:  2008-02-29       Impact factor: 17.440

2.  Creation of an institutional semi-independent data monitoring committee.

Authors:  Lisa R Tannock; Marietta Barton-Baxter; William W Stoops
Journal:  Clin Trials       Date:  2019-07-01       Impact factor: 2.486

3.  Maternal Perceptions of Safeguards for Research Involving Children.

Authors:  Maryam Rostami; Jane Paik Kim; Laura Turner-Essel; Laura Weiss Roberts
Journal:  J Child Fam Stud       Date:  2021-08-07

Review 4.  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 5.  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
  5 in total

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