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Publications & Presentations

Publications

Articles about the YODA Project

Overview and experience of the YODA Project with clinical trial data sharing after 5 years

Ross JS, Waldstreicher J, Bamford S, Berlin JA, Childers K, Desai NR, Gamble G, Gross CP, Kuntz R, Lehman R, Lins P, Morris SA, Ritchie JD, Krumholz HM. Overview and experience of the YODA Project with clinical trial data sharing after 5 years. Sci Data. 2018;5:180268.

The Open Translational Science in Schizophrenia project: an open-science project bringing together Janssen clinical trial and NIMH data

Wilcox MA, Savitz AJ, Addington AM, Gray GS, Guinan EC, Jackson JW, Lehner T, Normand SL, Ranu H, Senthil G, Spertus J, Valeri L, Ross JS. The Open Translational Science in Schizophrenia (OPTICS) project: an open-science project bringing together Janssen clinical trial and NIMH data. NPJ Schizophr. 2018;4(1):14.

Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project

Low J, Ross JS, Ritchie JD, Gross CP, Lehman R, Lin H, Fu R, Stewart LA, Krumholz HM. Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project. Systematic Reviews. 2017;6:28.

The Yale Open Data Access (YODA) Project- A mechanism for data sharing

Krumholz HM, Waldstreicher J. The Yale Open Data Access (YODA) Project- A mechanism for data sharingNEJM. 2016;375:403-405.

The OPTICS Project: An open-science framework for the analysis of clinical trial data</a>. <em>Psychiatric Times

Ross JS, Addington AM, Senthil G, Lehner T, Wilcox MA. The OPTICS Project: An open-science framework for the analysis of clinical trial data. Psychiatric Times. 2016;33.

Historic moment for open science: The Yale University Open Data Access Project and Medtronic

Krumholz HM, Ross JS, Gross CP, Emanuel EJ, Hodshon B, Ritchie JD, Low JB, Lehman R. A Historic moment for open science: The Yale University Open Data Access Project and Medtronic. Ann Intern Med. 2013;158:910-911.

A model for dissemination and independent analysis of industry data

Krumholz HM, Ross JS. A model for dissemination and independent analysis of industry data. JAMA. 2011;306:1593-1594.

 

Articles about Data Sharing

Early experiences with journal data sharing policies: A survey of published clinical trial investigators

Tannenbaum S, Ross JS, Krumholz HM, Desai NR, Ritchie JD, Lehman R, Gamble GM, Bachand J, Schroter S, Groves T, Gross CP. Early experiences with journal data sharing policies: A survey of published clinical trial investigators. Ann Intern Med. [Epub ahead of print 17 July 2018] doi: 10.7326/M18-0723.

Data sharing and cardiology: Platforms and possibilities

Dey P, Ross JS, Ritchie JD, Desai NR, Bhavnani SP, Krumholz HM. Data sharing and cardiology: Platforms and possibilities. JACC. 2017;70:3018-3025.

Research Letter: Merits of data sharing: the Digitalis Investigation Group trial

Angraal S, Ross JS, Desai N, Dhruva SS, Krumholz HM. Research Letter: Merits of data sharing: the Digitalis Investigation Group trial. JACC. 2017;70:1825-1826.

Data sharing through an NIH central database repository: A cross-sectional survey of BioLINCC users

Ross JS, Ritchie JD, Finn E, Desai NR, Lehman RL, Krumholz HM, Gross CP. Data sharing through an NIH central database repository: A cross-sectional survey of BioLINCC users. BMJ Open. 2016;6:e012769.

Clinical research data sharing: What an open science world means for researchers involved in evidence synthesis.

Ross JS. Clinical research data sharing: What an open science world means for researchers involved in evidence synthesis. Systematic Reviews. 2016;5:159.

Data acquisition, curation, and use for a continuously learning health system: A vital direction for health and health care.

Krumholz HM, Bourne PE, Kuntz RE, Paz HL, Terry SF, Waldstreicher J. Data acquisition, curation, and use for a continuously learning health system: A vital direction for health and health care. JAMA. 2016;epub ahead of print.

Availability of clinical trial data from industry-sponsored

Murugiah K, Ritchie JD, Desai NR, Ross JS, Krumholz HM. Availability of clinical trial data from industry-sponsored cardiovascular trials. J Am Heart Assoc. 2016;5:e003307.

Why data sharing should be the expected norm

Krumholz HM. Why data sharing should be the expected norm. BMJ. 2015;350:h599.

l 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. Predictors of clinical trial data sharing: Exploratory analysis of a cross-sectional survey. Trials. 2014;15:384.

Open access to clinical trials data

Krumholz HM, Peterson ED. Open access to clinical trials data. JAMA. 2014;312:1002-1003.

Sea change in open science and data sharing: leadership by industry

Krumholz HM, Gross CP, Blount KL, Ritchie JD, Hodshon B, Lehman R, Ross JS. Sea change in open science and data sharing: leadership by industry. Circ Cardiovasc Qual Outcomes. 2014;7:499-504.

Ushering in a new era of open science through data sharing: The wall must come down.

Ross JS, Krumholz HM. Ushering in a new era of open science through data sharing: The wall must come down. JAMA. 2013;309:1355-1356.

Implications of clinical trial data sharing for medical writers.

Ross JS, Krumholz HM. Implications of clinical trial data sharing for medical writers. Medical Writing. 2013;22:45-49.

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. Sharing of clinical trial data among trialists: A cross sectional survey. BMJ. 2012;345:e7570.

Open science and data sharing in clinical research: Basing informed decisions on the totality of the evidence.

Krumholz HM. Open science and data sharing in clinical research: Basing informed decisions on the totality of the evidence. Circ Cardiovasc Qual Outcomes. 2012;5:141-142.

The importance of clinical trial data sharing: Toward more open science.

Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: Toward more open science. Circ Cardiovasc Qual Outcomes. 2012;5:238-240.

Independent analysis of industry data necessary for promoting collaborative science

Krumholz HM. Independent analysis of industry data necessary for promoting collaborative science. Cardiology. 2012;41:9.

Missing clinical trial data

Lehman R, Loder E. Missing clinical trial data. BMJ. 2012;344:d8158.

 

Articles about Transparency

Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study

Zou CX, Becker JE, Phillips AT, Garritano JM, Krumholz HM, Miller JE, Ross JS. Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study. Trials. 2018;19(1):581.

Association of the FDA Amendment Act with trial regist

Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with trial registration, publication, and outcome reporting. Trials. 2017;18:333.

Data escrow and clinical trial transparency

Krumholz HM, Kim J. Data escrow and clinical trial transparency. Ann Intern Med. [Epub ahead of print 4 April 2017] doi: 10.7326/M17-0743

Publication of clinical studies supporting FDA premarket approval for high-risk cardiovascular devices between 2011 and 2013: A cross-sectional study

Phillips AT, Rathi VK, Ross JS. Publication of clinical studies supporting FDA premarket approval for high-risk cardiovascular devices between 2011 and 2013: A cross-sectional study. JAMA Intern Med. 2016;176:551-552.

Publication and reporting of clinical trial results: Cross sectional analysis across academic medical centers.

Chen R, Desai NR, Ross JS, Zhang W, Chau KH, Wayda B, Murugiah K, Lu DY, Mittal A, Krumholz HM. Publication and reporting of clinical trial results: Cross sectional analysis across academic medical centers. BMJ. 2016;352:i637.

Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications

Gopal AD, Desai NR, Tse T, Ross JS. Reporting of noninferiority trials in ClinicalTrials.gov and corresponding publications. JAMA. 2015;313:1163-1165.

Confronting bias

Ross JS. Confronting bias. JAMA Intern Med. 2015;175:307.

Time for a prepublication culture in clinical research?

Lauer MS, Krumholz HM, Topol EJ. Time for a prepublication culture in clinical research? Lancet. 2015;386:2447-2449.

US Federal Government efforts to improve clinical trial transparency with expanded trial registries

Shaw DL, Ross JS. US Federal Government efforts to improve clinical trial transparency with expanded trial registries and open data sharing. AMA Journal of Ethics. 2015;17:1152-1159.

The end of journals.

Krumholz HM. The end of journals. Circ Cardiovasc Qual Outcomes. 2015;8:00-00.

Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: A cross-sectional study.

Smithy JW, Downing NS, Ross JS. Publication of pivotal efficacy trials for novel therapeutic agents approved between 2005 and 2011: A cross-sectional study. JAMA Intern Med. 2014;174:1518-1520.

The medical reformation.

Lehman R. The medical reformation. BMJ. 2014;348:g3963.

Reporting of results in ClinicalTrials.gov and high-impact journals

Becker JE, Krumholz HM, Ben-Josef G, Ross JS. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA. 2014;311:1063-1065.

Time to publication among completed clinical trials

Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to publication among completed clinical trials. JAMA Intern Med. 2013;173:825-828.

Promoting transparency in pharmaceutical industry–sponsored research.

Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry–sponsored research. Am J Public Health. 2012;102:72-80.

Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis.

Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ. 2011;344:d7292.

Trial publication after registration in ClinicalTrials.Gov: A cross-sectional analysis.

Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: A cross-sectional analysis. PLoS Med. 2009;6:e1000144.

Registries and selection bias: The need for accountability

Krumholz HM. Registries and selection bias: The need for accountability. Circ Cardiovasc Qual Outcomes. 2009;2:517-518.

 

Other

An independent evaluation of the cardiovascular risk of rosiglitazone: meta-analysis of GSK’s publicly available clinical trial data.

Ross, JS. An independent evaluation of the cardiovascular risk of rosiglitazone: meta-analysis of GSK’s publicly available clinical trial data. Approved research proposal through ClinicalStudyDataRequest.com. Results available here.

How Do We Know the Value of Our Research?

Krumholz HM. How Do We Know the Value of Our Research? Circ Cardiovasc Qual Outcomes. 2013;6:371-372.

 

Presentations

Sharing Data through the YODA Project: Early Experiences and Lessons Learned "Sharing Data through the YODA Project: Early Experiences and Lessons Learned" (Given by Joseph S. Ross, MD, MHS, at the Center for Biomedical Research Transparency Summit, February 15, 2019)
Openness About Clinical Trial Results: Lessons from the Front Line "Openness About Clinical Trial Results: Lessons from the Front Line" (Given by Joseph S. Ross, MD, MHS, at the American Association for the Advancement of Science Annual Meeting, February 15, 2019)
Sharing Data through the YODA Project: Early Experience "Sharing Data through the YODA Project: Early Experience" (Given by Joseph S. Ross, MD, MHS, at the Eighth International Congress on Peer Review and Scientific Publication, September 10, 2017)
Clinical Trial Data Sharing and Reproducibility "Clinical Trial Data Sharing and Reproducibility" (Given by Harlan M. Krumholz, MD, SM, and Jeffrey M. Drazen, MD, at the Harvard Medical School Health Policy and Bioethics Consortium Meeting, December 7, 2016)
The Yale Open Data Access (YODA) Project: Repurposing Data for Researchers "The Yale Open Data Access (YODA) Project: Repurposing Data for Researchers" (Given by Jessica Ritchie Klein, MPH, PMP, at the American Library Association Annual Meeting, June 27, 2016)
The Yale Open Data Access (YODA) Project: Lessons Learned in Data Sharing "The Yale Open Data Access (YODA) Project: Lessons Learned in Data Sharing" (Given by Joseph S. Ross, MD, MHS, at the Society for Clinical Trials Annual Meeting, May 18, 2016)
Data Sharing: Perspectives from a Third Party, Independent Academic Process (YODA) "Data Sharing: Perspectives from a Third Party, Independent Academic Process (YODA)" (Given by Joseph S. Ross, MD, MHS, at the CBI Conference on Clinical Data Disclosure and Transparency, January 29, 2015)
Clinical Trial Data Sharing "Clinical Trial Data Sharing" (Given by Joseph S. Ross, MD, MHS, at the NPA FDA Taskforce Meeting, December 15, 2014)
BMP Use: Evaluating Industry-Funded Trials "BMP Use: Evaluating Industry-Funded Trials" (Given by Kevin Bozic, MD, at the American Academy of Orthopaedic Surgeons (AAOS), Orthopaedic Research Society (ORS) Clinical Research Forum, February 6, 2012)
A Model for Dissemination and Independent Analysis of Clinical Trial Program Data "A Model for Dissemination and Independent Analysis of Clinical Trial Program Data" (Given by Harlan Krumholz, MD, at the American College of Cardiology (ACC) Board of Trustees Meeting, December 5, 2011)