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

Trials
Chiara Pandolfini, Maurizio Bonati

Abstract

Clinical trial registries have been a priority topic in the past few years in promoting data transparency and accountability. In this context, in 2011, the IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri" set up a registry to collect data on all studies in which the institute's researchers are involved. In this study we present a self-audit in order to detect the lead researchers' general knowledge on registries, the completeness and quality of the randomized controlled trial (RCT) data inputted in an Italian research institute's registry, and the researchers' adherence to both registration requirements and the institute transparency goal, aiming to improve standards and leading to greater awareness of the issues involved. A questionnaire-based audit was conducted. To interview researchers we included questions ranging from general knowledge on registries (e.g., what are the aims of registries?) to questions about their knowledge of the Mario Negri's registry, questions on selected trials and registration, included information on the protocol, and the results. The audit sample covers 12 of the 47 RCTs at the institute's Milan branch, representing all the possible lead researchers responsible for RCTs at the institute. ...Continue Reading

References

May 25, 2005·JAMA : the Journal of the American Medical Association·Catherine D DeangelisUNKNOWN International Committee of Medical Journal Editors
Jun 15, 2012·The Cochrane Database of Systematic Reviews·Noah IversAndrew D Oxman
May 21, 2013·European Journal of Clinical Pharmacology·Chiara PandolfiniMaurizio Bonati
Jan 17, 2014·BMJ : British Medical Journal·Ben Goldacre, Carl Heneghan
Apr 2, 2014·Annals of Internal Medicine·Daniel M HartungMark Helfand
May 20, 2014·BMJ : British Medical Journal·Lamberto ManzoliJohn P A Ioannidis
Dec 30, 2014·The New England Journal of Medicine·Deborah A ZarinJerry Sheehan
Feb 19, 2016·BMJ : British Medical Journal·Ruijun ChenHarlan M Krumholz
Mar 1, 2017·Trials·Claudia PansieriMaurizio Bonati
Jul 28, 2017·BMJ : British Medical Journal·Ben GoldacreLiam Smeeth

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Citations

Aug 19, 2020·Alzheimer's Research & Therapy·Justin BauzonJeffrey Cummings

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