Literature DB >> 23686331

Clinical trial registries: from an omen to a common and disclosed practice.

Chiara Pandolfini1, Silvio Garattini, Maurizio Bonati.   

Abstract

OBJECTIVE: Clinical trials registries are important for guaranteeing trustworthy scientific knowledge. Despite international initiatives promoting trial registration, however, complete and high quality disclosure of trial information in such registries is not routine. The role of registries in also increasing transparency is fundamental, and these databases could be contemplated by research organizations, even at more local levels.
METHODS: A rare initiative was set up at the IRCCS-Mario Negri Institute for Pharmacological Research in Milan in order to make the institute's ongoing research accessible to anyone.
RESULTS: The register currently includes 112 studies in which the institute participates.
CONCLUSIONS: Work still needs to be done to improve the registry, but it is up and functional. Could, or should, such registries be routine for all scientific institutions?

Mesh:

Year:  2013        PMID: 23686331     DOI: 10.1007/s00228-013-1526-4

Source DB:  PubMed          Journal:  Eur J Clin Pharmacol        ISSN: 0031-6970            Impact factor:   2.953


  9 in total

1.  Trial registration: a great idea switches from ignored to irresistible.

Authors:  Drummond Rennie
Journal:  JAMA       Date:  2004-09-08       Impact factor: 56.272

2.  Clinical trial registration: a statement from the International Committee of Medical Journal Editors.

Authors:  Catherine De Angelis; Jeffrey M Drazen; Frank A Frizelle; Charlotte Haug; John Hoey; Richard Horton; Sheldon Kotzin; Christine Laine; Ana Marusic; A John P M Overbeke; Torben V Schroeder; Hal C Sox; Martin B Van Der Weyden
Journal:  Lancet       Date:  2004 Sep 11-17       Impact factor: 79.321

Review 3.  Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1).

Authors:  Karmela Krleza-Jerić; An-Wen Chan; Kay Dickersin; Ida Sim; Jeremy Grimshaw; Christian Gluud
Journal:  BMJ       Date:  2005-04-23

4.  Clinical trial registration: transparency is the watchword.

Authors:  Ida Sim; An-Wen Chan; A Metin Gülmezoglu; Tim Evans; Tikki Pang
Journal:  Lancet       Date:  2006-05-20       Impact factor: 79.321

5.  National and multinational prospective trial registers.

Authors:  Liesl Grobler; Nandi Siegfried; Lisa Askie; Lotty Hooft; Prathap Tharyan; Gerd Antes
Journal:  Lancet       Date:  2008-10-04       Impact factor: 79.321

6.  Clinical trial data as a public good.

Authors:  Marc A Rodwin; John D Abramson
Journal:  JAMA       Date:  2012-09-05       Impact factor: 56.272

7.  All trials must be registered and the results published.

Authors:  Iain Chalmers; Paul Glasziou; Fiona Godlee
Journal:  BMJ       Date:  2013-01-09

8.  Registering clinical trials.

Authors:  Kay Dickersin; Drummond Rennie
Journal:  JAMA       Date:  2003-07-23       Impact factor: 56.272

9.  Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

Authors:  S Swaroop Vedula; Tianjing Li; Kay Dickersin
Journal:  PLoS Med       Date:  2013-01-29       Impact factor: 11.069

  9 in total
  3 in total

Review 1.  The evolution in registration of clinical trials: a chronicle of the historical calls and current initiatives promoting transparency.

Authors:  Claudia Pansieri; Chiara Pandolfini; Maurizio Bonati
Journal:  Eur J Clin Pharmacol       Date:  2015-08-05       Impact factor: 2.953

Review 2.  An audit to evaluate an institute's lead researchers' knowledge of trial registries and to investigate adherence to data transparency issues in an Italian research institute registry.

Authors:  Chiara Pandolfini; Maurizio Bonati
Journal:  Trials       Date:  2018-09-20       Impact factor: 2.279

3.  Balkan Clinical Research Registry: Established by Academy of Medical Sciences of Bosnia and Herzegovina.

Authors:  Izet Masic; Slobodan M Jankovic; Asim Kurjak; Doncho M Donev; Muharem Zildzic; Osman Sinanovic; Izet Hozo; Snjezana Milicevic; Sefik Hasukic; Emir Mujanovic; Kenan Arnautovic; Senaid Trnacevic; Enisa Mesic; Mirza Biscevic; Mustafa Sefic; Vjekoslav Gerc; Abdulah Kucukalic; Zlatko Hrgovic; Jacob Bergsland; Mirko Grujic
Journal:  Med Arch       Date:  2020-12
  3 in total

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