Timely publication and sharing of trial data: opportunities and challenges for comparative effectiveness research in cardiovascular disease

European Heart Journal. Quality of Care & Clinical Outcomes
Huseyin NaciElias Mossialos

Abstract

There is growing enthusiasm for the timely publication and sharing of clinical trial data. The rationale for open access includes greater transparency, reproducibility, and efficiency of the research enterprise. In cardiovascular diseases, routinely sharing clinical trial data would create opportunities for undertaking comparative effectiveness research, providing much needed evidence on how different interventions compare to each other on key outcomes. Access to individual patient-level data would strengthen the validity of such research. Novel methodological approaches like network meta-analyses using individual patient-level data could reliably compare interventions that have not been compared with each other in head-to-head trials. However, there are significant practical, methodological, financial, and legal challenges to this utopian open access that need to be continually addressed. Sharing clinical trial data openly will only occur when the previously tolerated process of clinical research involving direct ownership and secrecy is abandoned for a new culture in which medical science is open to all of its stakeholders. With this new culture, data will be accessible, reanalysis will be considered commonplace, and comparat...Continue Reading

References

Feb 5, 1998·JAMA : the Journal of the American Medical Association·J P Ioannidis
Mar 1, 2002·Evaluation & the Health Professions·Lesley A Stewart, Jayne F Tierney
Nov 19, 2002·JAMA : the Journal of the American Medical Association·Carl van WalravenBeppie Hellemons
Jul 24, 2003·JAMA : the Journal of the American Medical Association·Monika K KrzyzanowskaIan F Tannock
Jan 22, 2005·The New England Journal of Medicine·Gust H BardyUNKNOWN Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators
Oct 15, 2005·BMJ : British Medical Journal·Deborah M CaldwellJ P T Higgins
Jan 18, 2008·The New England Journal of Medicine·Erick H TurnerRobert Rosenthal
Sep 5, 2008·PharmacoEconomics·Alex SuttonKeith Abrams
Jun 9, 2009·The New England Journal of Medicine·UNKNOWN BARI 2D Study GroupBurton E Sobel
Apr 15, 2010·Trials·Natalie McGauranThomas Kaiser
Aug 4, 2010·Annals of Internal Medicine·Harold C Sox
Jan 5, 2012·BMJ : British Medical Journal·Joseph S RossHarlan M Krumholz
Mar 17, 2012·BMJ : British Medical Journal·Xin SunGordon H Guyatt
Jul 6, 2012·Statistics in Medicine·Pedro SaramagoAndrea Manca
Oct 16, 2012·BMJ : British Medical Journal·Rebecca Coombes
Nov 22, 2012·BMJ : British Medical Journal·Fiona Godlee, Trish Groves
Mar 20, 2013·JAMA : the Journal of the American Medical Association·Joseph S Ross, Harlan M Krumholz
Jun 20, 2013·Annals of Internal Medicine·Harlan M KrumholzRichard Lehman
Oct 23, 2013·The New England Journal of Medicine·Michelle M MelloMark Barnes
Oct 23, 2013·The New England Journal of Medicine·Hans-Georg EichlerGuido Rasi
Dec 4, 2013·Trends in Pharmacological Sciences·Peter DoshiJohn P A Ioannidis
Jan 15, 2014·Lancet·John P A IoannidisRobert Tibshirani
Jan 15, 2014·Lancet·An-Wen ChanH Bart van der Worp
Jan 23, 2014·JAMA : the Journal of the American Medical Association·Xin SunGordon Guyatt
Feb 7, 2014·BMJ : British Medical Journal·Zosia Kmietowicz
Aug 19, 2014·Lancet·UNKNOWN Blood Pressure Lowering Treatment Trialists' Collaboration
Sep 10, 2014·JAMA : the Journal of the American Medical Association·Shanil EbrahimJohn P A Ioannidis
Mar 12, 2015·The New England Journal of Medicine·Monique L AndersonRobert M Califf

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Citations

Sep 7, 2018·European Journal of Clinical Nutrition·M J Soares, M J Müller
Nov 1, 2015·European Heart Journal. Quality of Care & Clinical Outcomes·Marcus Flather
Oct 25, 2020·European Heart Journal. Quality of Care & Clinical Outcomes·Chris J KapeliosElias Mossialos

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