Literature DB >> 17507347

Issues in the registration of clinical trials.

Deborah A Zarin1, Nicholas C Ide, Tony Tse, William R Harlan, Joyce C West, Donald A B Lindberg.   

Abstract

Public concerns about the perils associated with incomplete or delayed reporting of results from clinical trials has heightened interest in trial registries and results databases. Here we review the current status of trial registration efforts and the challenges in developing a comprehensive system of trial registration and reporting of results. ClinicalTrials.gov, the largest trial registry with 36 249 trials from approximately 140 countries, has procedures in place to help ensure that records are valid and informative. Key challenges include the need to minimize inadvertent duplicate registrations, to ensure that interventions have unambiguous names, and to have a search engine that identifies all trials that meet a user's specifications. Recent policy initiatives have called for the development of a database of trial results. Several issues confound the implementation of such a database, including the lack of an accepted format or process for providing summaries of trial results to the public and concerns about disseminating data in the absence of independent scientific review.

Mesh:

Year:  2007        PMID: 17507347     DOI: 10.1001/jama.297.19.2112

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


  65 in total

1.  Should preclinical studies be registered?

Authors:  Jonathan Kimmelman; James A Anderson
Journal:  Nat Biotechnol       Date:  2012-06-07       Impact factor: 54.908

2.  Reporting discrepancies between the ClinicalTrials.gov results database and peer-reviewed publications.

Authors:  Daniel M Hartung; Deborah A Zarin; Jeanne-Marie Guise; Marian McDonagh; Robin Paynter; Mark Helfand
Journal:  Ann Intern Med       Date:  2014-04-01       Impact factor: 25.391

3.  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

4.  Medicine. Moving toward transparency of clinical trials.

Authors:  Deborah A Zarin; Tony Tse
Journal:  Science       Date:  2008-03-07       Impact factor: 47.728

5.  Fifteenth anniversary of the Croatian Medical Journal: still moving ahead.

Authors:  Mirjana Huić
Journal:  Croat Med J       Date:  2008-02       Impact factor: 1.351

6.  An automated communication system in a contact registry for persons with rare diseases: scalable tools for identifying and recruiting clinical research participants.

Authors:  R L Richesson; H S Lee; D Cuthbertson; J Lloyd; K Young; J P Krischer
Journal:  Contemp Clin Trials       Date:  2008-09-07       Impact factor: 2.226

7.  The Primary Care Research Object Model (PCROM): a computable information model for practice-based primary care research.

Authors:  Stuart M Speedie; Adel Taweel; Ida Sim; Theodoros N Arvanitis; Brendan Delaney; Kevin A Peterson
Journal:  J Am Med Inform Assoc       Date:  2008-06-25       Impact factor: 4.497

8.  Rising expectations: access to biomedical information.

Authors:  D A B Lindberg; B L Humphreys
Journal:  Yearb Med Inform       Date:  2008

9.  Network analysis of clinical trials on depression: implications for comparative effectiveness research.

Authors:  Suresh K Bhavnani; Simona Carini; Jessica Ross; Ida Sim
Journal:  AMIA Annu Symp Proc       Date:  2010-11-13

10.  Serum correlates of the placebo effect in irritable bowel syndrome.

Authors:  E Kokkotou; L A Conboy; D C Ziogas; M T Quilty; J M Kelley; R B Davis; A J Lembo; T J Kaptchuk
Journal:  Neurogastroenterol Motil       Date:  2009-12-22       Impact factor: 3.598

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