Publications & Presentations

Publications

Articles about the YODA Project

Journal article title page for characteristics of available studies and dissemination of research using major clinical data sharing platforms

Vazquez E, Gouraud H, Naudet F, Gross CP, Krumholz HM, Ross JS, Wallach JD. Characteristics of available studies and dissemination of research using major clinical data sharing platforms. Clin Trials. 2021 Aug 18:17407745211038524. doi: 10.1177/17407745211038524

Journal article title page for sharing clinical trials data: lessons from the YODA project

Ross JS, Waldstreicher J, Krumholz HM. Sharing clinical trial data: lessons from the YODA Project. STAT News. 2019.

Journal article title page for 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.

Journal article title page for the open translational science in OPTICS

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.

Journal article title page for comparison of two independent systematic reviews of trials of recombinant human bone morphogenic protein

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.

Journal article title page for a mechanism for data sharing

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

Journal article title page for the OPTICS project: an open science framework for the analysis of clinical trial data

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.

Journal article title page for a 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.

Journal article title page for 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

Ross JS, Waldstreicher J, Krumholz HM. Data Sharing – A New Era for Research Funded by the U.S. Government. N Engl J Med. 2023 Nov 15. doi: 10.1056/NEJMp2308792. Epub ahead of print. PMID: 37966303.

 

 

Rowhani-Farid A, Grewal M, Solar S, Eghari A, Zhang A, Gross C, Krumholz H, Ross J. Clinical trial data sharing: a cross-sectional study of outcomes associated with two U.S. National Institutes of Health models. Sci Data. 2023:10;529. https://doi.org/10.1038/s41597-023-02436-0

Journal article title page for early expectations 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.

Journal article title page for data sharing and cardio.

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

Journal article title page for merits of data sharing

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.

Journal article title page for 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.

Journal article title page for clinical research data sharing
Journal article title page for Data acquisition, curation and use for a continuously leaning health system

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.

Journal article title page for availability of clinical trial data from industry sponsored cardiovascular trials

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.

Journal article title page for why data should be the expected norm

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

Journal article title page for 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. Predictors of clinical trial data sharing: Exploratory analysis of a cross-sectional survey. Trials. 2014;15:384.

Journal article title page for open access to clinical trials data

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

Journal article title page for sea change in open science and data sharing

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.

Journal article title page for ushering in new era of open science
Journal article title page for implications of clinical trial data sharing for medical writers

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

Journal article title page for 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 surveyBMJ. 2012;345:e7570.

Journal article title page for open science and data sharing in clinical research
Journal article title page for the important of clinical trial data sharing

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

Journal article title page for Independent analysis of industry Data Necessary for promoting collab. sci.
Journal article title page for missing clinical trial data

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

Articles about Transparency

Journal article title page for registration, results reporting and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA
Journal article title page for association of the FDA amendment act with trial registration, publication and outcome reporting

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.

Journal article title page for 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

Journal article title page for Publication of clinical studies supporting FDA premarket approval for high risk cardiovascular devices between 2011 and 2013
Journal article title page for publication and reporting of clinical trials 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 (pdf). BMJ. 2016;352:i637.

Journal article title page for noninferiority in CT.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.

Journal article title page for confronting bias

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

Journal article title page for 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.

Journal article title page for US federal government efforts to improve clinical trial transparency with expanded trial registries and open data sharing
Journal article title page for the end of journals

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

Journal article title page for publication of photo efficacy trials for novel
Journal article title page for the medical reformation

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

Journal article title page for reporting results in ct.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.

Journal article title page for 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.

Journal article title page for 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.

Journal article title page for publication of NIH funded trials registeed in CT.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.

Journal article title page for trial publication after registration in ct.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.

Journal article title page for registries and selection bias

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

Other

Journal article title page for updating insights into rosiglitazone and cardiovascular risk through shared data: independent patient and summary level meta-analysis

Wallach JD, Wang K, Zhang AD, Cheng D, Grossetta Nardini HK, Lin H, Bracken MB, Desai M, Krumholz HM, Ross JS. Updating insights into rosiglitazone and cardiovascular risk through shared data: individual patient and summary level meta-analyses. BMJ. 2020 Feb 5;368:l7078.

Approved research proposal through ClinicalStudyDataRequest.com. You can view the results of the study on the MedRxiv website.

Journal article title page for 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 Patient-Level Clinical Trial Data: The YODA Model (pdf)” (Given by Cary P. Gross, MD at the National Brain Tumor Society Research Roundtable, July 20, 2023)

Slide presentation title page for a use case and lessons learned

“The YODA Project: A Use Case and Lessons Learned” (pdf) (Given by Joseph S. Ross, MD, MHS, at the National Academies Challenges and a Way Forward in Sharing Clinical Trial Data Workshop, November 18, 2019)

Slide presentation title page for sharing data through the YODA Project early experiences and lessons learned

“Sharing Data through the YODA Project: Early Experiences and Lessons Learned” (pdf) (Given by Joseph S. Ross, MD, MHS, at the Center for Biomedical Research Transparency Summit, February 15, 2019)

Slide presentation title page for openness about clinical trial results lessons from the front line

“Openness About Clinical Trial Results: Lessons from the Front Line” (pdf) (Given by Joseph S. Ross, MD, MHS, at the American Association for the Advancement of Science Annual Meeting, February 15, 2019)

Slide presentation title page for sharing data through the YODA project early experience

“Sharing Data through the YODA Project: Early Experience” (pdf) (Given by Joseph S. Ross, MD, MHS, at the Eighth International Congress on Peer Review and Scientific Publication, September 10, 2017)

Slide presentation title page for 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)

Slide presentation title page for: repurposing data for researchers

“The Yale Open Data Access (YODA) Project: Repurposing Data for Researchers” (pdf) (Given by Jessica Ritchie Klein, MPH, PMP, at the American Library Association Annual Meeting, June 27, 2016)

Slide presentation title page for lessions learned in data sharing

“The Yale Open Data Access (YODA) Project: Lessons Learned in Data Sharing” (pdf) (Given by Joseph S. Ross, MD, MHS, at the Society for Clinical Trials Annual Meeting, May 18, 2016)

Slide presentation title page for data sharing: perspectives from a 3rd party, Independent academic process

“Data Sharing: Perspectives from a Third Party, Independent Academic Process (YODA)” (pdf) (Given by Joseph S. Ross, MD, MHS, at the CBI Conference on Clinical Data Disclosure and Transparency, January 29, 2015)

Slide presentation title page for Clinical trial data sharing

“Clinical Trial Data Sharing” (pdf) (Given by Joseph S. Ross, MD, MHS, at the NPA FDA Taskforce Meeting, December 15, 2014)

Slide presentation title page for BMP use: Evaluating Industry funded trials

“BMP Use: Evaluating Industry-Funded Trials” (pdf) (Given by Kevin Bozic, MD, at the American Academy of Orthopaedic Surgeons (AAOS), Orthopaedic Research Society (ORS) Clinical Research Forum, February 6, 2012)

Slide presentation title page for a model for dissemination and independent analysis of clinical trial program data

“A Model for Dissemination and Independent Analysis of Clinical Trial Program Data” (pdf) (Given by Harlan Krumholz, MD, at the American College of Cardiology (ACC) Board of Trustees Meeting, December 5, 2011)