Literature DB >> 26464136

North American regulatory agencies can and should make clinical trial data publicly available.

Nav Persaud1, Peter Doshi2.   

Abstract

Mesh:

Year:  2015        PMID: 26464136      PMCID: PMC4732955          DOI: 10.1503/cmaj.150679

Source DB:  PubMed          Journal:  CMAJ        ISSN: 0820-3946            Impact factor:   8.262


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  8 in total

Review 1.  Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.

Authors:  Aaron S Kesselheim; Michelle M Mello
Journal:  Health Aff (Millwood)       Date:  2007 Mar-Apr       Impact factor: 6.301

2.  Opening up data at the European Medicines Agency.

Authors:  Peter C Gøtzsche; Anders W Jørgensen
Journal:  BMJ       Date:  2011-05-10

3.  Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results.

Authors:  Matthew Herder
Journal:  CMAJ       Date:  2011-08-29       Impact factor: 8.262

4.  Increasing value and reducing waste: addressing inaccessible research.

Authors:  An-Wen Chan; Fujian Song; Andrew Vickers; Tom Jefferson; Kay Dickersin; Peter C Gøtzsche; Harlan M Krumholz; Davina Ghersi; H Bart van der Worp
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

5.  Underreporting research is scientific misconduct.

Authors:  I Chalmers
Journal:  JAMA       Date:  1990-03-09       Impact factor: 56.272

6.  World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.

Authors: 
Journal:  JAMA       Date:  2013-11-27       Impact factor: 56.272

Review 7.  Agomelatine efficacy and acceptability revisited: systematic review and meta-analysis of published and unpublished randomised trials.

Authors:  Markus Koesters; Giuseppe Guaiana; Andrea Cipriani; Thomas Becker; Corrado Barbui
Journal:  Br J Psychiatry       Date:  2013-09       Impact factor: 9.319

Review 8.  Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.

Authors:  Tom Jefferson; Mark Jones; Peter Doshi; Elizabeth A Spencer; Igho Onakpoya; Carl J Heneghan
Journal:  BMJ       Date:  2014-04-09
  8 in total
  5 in total

1.  Increasing the transparency of clinical data.

Authors:  Pierre Sabourin; Supriya Sharma
Journal:  CMAJ       Date:  2017-03-27       Impact factor: 8.262

2.  Secrecy or transparency? The future of regulatory trial data.

Authors:  Beate Wieseler; Natalie McGauran
Journal:  CMAJ       Date:  2016-11-14       Impact factor: 8.262

3.  Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

Authors:  Peter Doshi; Peter Hur; Mark Jones; Husam Albarmawi; Tom Jefferson; Daniel J Morgan; Patricia A Spears; John H Powers
Journal:  JAMA Intern Med       Date:  2017-10-01       Impact factor: 21.873

4.  ClinicalTrials.gov for Facilitating Rapid Understanding of Potential Harms of New Drugs: The Case of Checkpoint Inhibitors.

Authors:  Annie Yang; Shrujal Baxi; Deborah Korenstein
Journal:  J Oncol Pract       Date:  2018-01-03       Impact factor: 3.840

5.  Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports.

Authors:  Emma Maund; Louise Schow Guski; Peter C Gøtzsche
Journal:  CMAJ       Date:  2016-11-14       Impact factor: 8.262

  5 in total

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