A model for dissemination and independent analysis of industry data

doi:10.1001/jama.2011.1459

. 2011 Oct 12;306(14):1593-4.

doi: 10.1001/jama.2011.1459.

A model for dissemination and independent analysis of industry data

Harlan M Krumholz¹, Joseph S Ross

Affiliations

Affiliation

¹ Section of Cardiovascular Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA. harlan.krumholz@yale.edu

PMID: 21990302
PMCID: PMC3688082
DOI: 10.1001/jama.2011.1459

A model for dissemination and independent analysis of industry data

Harlan M Krumholz et al. JAMA. 2011.

. 2011 Oct 12;306(14):1593-4.

doi: 10.1001/jama.2011.1459.

Authors

Harlan M Krumholz¹, Joseph S Ross

Affiliation

¹ Section of Cardiovascular Medicine and the Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA. harlan.krumholz@yale.edu

PMID: 21990302
PMCID: PMC3688082
DOI: 10.1001/jama.2011.1459

No abstract available

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest: Dr. Krumholz chairs a cardiac scientific advisory board for UnitedHealth. Dr. Ross is a member of a scientific advisory board for FAIR Health, Inc.

Figures

**Figure**
Model for Dissemination and Independent Analysis of Industry Data.

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Cited by

Increasing value and reducing waste: addressing inaccessible research.
Chan AW, Song F, Vickers A, Jefferson T, Dickersin K, Gøtzsche PC, Krumholz HM, Ghersi D, van der Worp HB. Chan AW, et al. Lancet. 2014 Jan 18;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. Epub 2014 Jan 8. Lancet. 2014. PMID: 24411650 Free PMC article.
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey.
Rathi VK, Strait KM, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Dzara K, Ross JS. Rathi VK, et al. Trials. 2014 Oct 2;15:384. doi: 10.1186/1745-6215-15-384. Trials. 2014. PMID: 25277128 Free PMC article.
Anonymising and sharing individual patient data.
El Emam K, Rodgers S, Malin B. El Emam K, et al. BMJ. 2015 Mar 20;350:h1139. doi: 10.1136/bmj.h1139. BMJ. 2015. PMID: 25794882 Free PMC article.
Sharing of clinical trial data among trialists: a cross sectional survey.
Rathi V, Dzara K, Gross CP, Hrynaszkiewicz I, Joffe S, Krumholz HM, Strait KM, Ross JS. Rathi V, et al. BMJ. 2012 Nov 20;345:e7570. doi: 10.1136/bmj.e7570. BMJ. 2012. PMID: 23169870 Free PMC article.
Clinical Trial Participants' Views of the Risks and Benefits of Data Sharing.
Mello MM, Lieou V, Goodman SN. Mello MM, et al. N Engl J Med. 2018 Jun 7;378(23):2202-2211. doi: 10.1056/NEJMsa1713258. N Engl J Med. 2018. PMID: 29874542 Free PMC article.

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References

1. Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. - PMC - PubMed
1. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009 Sep;6(9) e1000144. - PMC - PubMed
1. Marciniak TA. Memorandum: Cardiovascular events in RECORD, NDA 21-071/S035. [Accessed September 7, 2011];FDA briefing document, advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) table. 2010 Jun 14; www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrin....
1. Ross JS, Madigan D, Konstam MA, Egilman DS, Krumholz HM. Persistence of cardiovascular risk after rofecoxib discontinuation. Arch Intern Med. 2010;170(22):2035–2036. - PMC - PubMed
1. Lyman GH, Kuderer NM. The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol. 2005;5:14. - PMC - PubMed

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[1] Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. - PMC - PubMed

[2] Eyding D, Lelgemann M, Grouven U, et al. Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials. BMJ. 2010;341:c4737. - PMC - PubMed

[3] Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009 Sep;6(9) e1000144. - PMC - PubMed

[4] Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med. 2009 Sep;6(9) e1000144. - PMC - PubMed

[5] Marciniak TA. Memorandum: Cardiovascular events in RECORD, NDA 21-071/S035. [Accessed September 7, 2011];FDA briefing document, advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) table. 2010 Jun 14; www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrin....

[6] Marciniak TA. Memorandum: Cardiovascular events in RECORD, NDA 21-071/S035. [Accessed September 7, 2011];FDA briefing document, advisory committee meeting for NDA 21071 Avandia (rosiglitazone maleate) table. 2010 Jun 14; www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Endocrin....

[7] Ross JS, Madigan D, Konstam MA, Egilman DS, Krumholz HM. Persistence of cardiovascular risk after rofecoxib discontinuation. Arch Intern Med. 2010;170(22):2035–2036. - PMC - PubMed

[8] Ross JS, Madigan D, Konstam MA, Egilman DS, Krumholz HM. Persistence of cardiovascular risk after rofecoxib discontinuation. Arch Intern Med. 2010;170(22):2035–2036. - PMC - PubMed

[9] Lyman GH, Kuderer NM. The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol. 2005;5:14. - PMC - PubMed

[10] Lyman GH, Kuderer NM. The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol. 2005;5:14. - PMC - PubMed

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A model for dissemination and independent analysis of industry data

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A model for dissemination and independent analysis of industry data

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