YODA Project

The YODA (Yale Open Data Access) Project is a Yale University project to promote open data in clinical research.

Originating as a model for the dissemination and independent analysis of industry data, the YODA Project is an effort by a group of academically-based clinical researchers to facilitate access to participant-level clinical research data and/or comprehensive reports of clinical research, such as full Clinical Study Reports [CSRs]. The YODA Project's mission is to advocate for the responsible sharing of clinical trial data, open science, and research transparency with the aim of promoting research that may advance science or lead to improvements in individual health, public health, and healthcare delivery.

The YODA Project has served as a trusted intermediary in a variety of collaborative efforts to make scientific data more broadly available to researchers. As the expectation for open science and research transparency expands,^[1] the YODA Project continues to evolve as a leader in responsible data access while maintaining the touchstone of its core values. The YODA Project approach to data sharing^[2] is unique in the following ways:

• The YODA Project is an independent, academic, third party without interest in the data, removing the perception of influence over access
• Data sharing partners have given the YODA Project full jurisdiction to make decisions regarding data access
• The YODA Project reviews requests and associated registration materials to ensure that all required information is completely submitted, and is committed to facilitating secure access to these data for scientific purposes

The YODA Project is currently partnering with Johnson & Johnson ^[3] and SI-BONE, Inc.^[4] to facilitate access to their clinical trial data. Access can be requested for 170 clinical trials for a wide range of Johnson & Johnson’s pharmaceutical products and medical devices and one SI-BONE clinical trial on triangular titanium implants. Inquiries for data availability for unlisted trials from these data holders can also be submitted.^[5]

References

1. Taichman, Darren B.; Backus, Joyce; Baethge, Christopher; Bauchner, Howard; de Leeuw, Peter W.; Drazen, Jeffrey M.; Fletcher, John; Frizelle, Frank A.; Groves, Trish; Haileamlak, Abraham; James, Astrid; Laine, Christine; Peiperl, Larry; Pinborg, Anja; Sahni, Peush; Wu, Sinan (28 January 2016). "Sharing Clinical Trial Data — A Proposal from the International Committee of Medical Journal Editors". New England Journal of Medicine. 374 (4): 384–386. doi:10.1056/NEJMe1515172. ISSN 0028-4793.
2. "The YODA Project Policies & Procedures to Guide External Investigator Access to Clinical Trial Data". yoda.yale.edu.
3. "Johnson & Johnson Announces Clinical Trial Data Sharing Agreement with Yale School of Medicine | Johnson & Johnson". www.jnj.com. Retrieved 22 August 2016.
4. Hofheinz, Elizabeth. "Yale, SI-BONE Commence Data Transparency Project | Orthopedics This Week". ryortho.com. Retrieved 22 August 2016.
5. "BioLINCC: Yale University Open Data Access Project (YODA)". National Heart, Lung, and Blood Institute. Retrieved 17 August 2016.  This article incorporates text from this source, which is in the public domain.

External links

• Official website

• Krumholz, Harlan M.; Waldstreicher, Joanne (4 August 2016). "The Yale Open Data Access (YODA) Project — A Mechanism for Data Sharing". New England Journal of Medicine. 375 (5): 403–405. doi:10.1056/NEJMp1607342. ISSN 0028-4793.

• Murugiah, Karthik; Ritchie, Jessica D.; Desai, Nihar R.; Ross, Joseph S.; Krumholz, Harlan M. (1 April 2016). "Availability of Clinical Trial Data From Industry‐Sponsored Cardiovascular Trials". Journal of the American Heart Association. 5 (4): e003307. doi:10.1161/JAHA.116.003307. ISSN 2047-9980.

• Ross, Joseph S.; Addington, Anjené M.; Lehner, Thomas; Wilcox, Marsha A. (25 January 2016). "The OPTICS Project: An Open-Science Framework for the Analysis of Clinical Trial Data". Psychiatric Times. Retrieved 25 August 2016.

• Chen, Ruijun; Desai, Nihar R.; Ross, Joseph S.; Zhang, Weiwei; Chau, Katherine H.; Wayda, Brian; Murugiah, Karthik; Lu, Daniel Y.; Mittal, Amit; Krumholz, Harlan M. (17 February 2016). "Publication and reporting of clinical trial results: cross sectional analysis across academic medical centers" (PDF). BMJ. 352: i637. doi:10.1136/bmj.i637. ISSN 1756-1833.

• Krumholz, Harlan M. (5 February 2015). "Why data sharing should be the expected norm". BMJ. 350: h599. doi:10.1136/bmj.h599. ISSN 1756-1833.

• Rathi, Vinay K.; Strait, Kelly M.; Gross, Cary P.; Hrynaszkiewicz, Iain; Joffe, Steven; Krumholz, Harlan M.; Dzara, Kristina; Ross, Joseph S. (1 January 2014). "Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey". Trials. 15: 384. doi:10.1186/1745-6215-15-384. ISSN 1745-6215.

• Krumholz, Harlan M.; Gross, Cary P.; Blount, Katrina L.; Ritchie, Jessica D.; Hodshon, Beth; Lehman, Richard; Ross, Joseph S. (1 July 2014). "Sea Change in Open Science and Data Sharing Leadership by Industry". Circulation: Cardiovascular Quality and Outcomes. 7 (4): 499–504. doi:10.1161/CIRCOUTCOMES.114.001166. ISSN 1941-7705.

• Ross, Joseph S.; Krumholz, Harlan M. (3 April 2013). "Ushering in a New Era of Open Science Through Data Sharing". JAMA. 309 (13): 1355. doi:10.1001/jama.2013.1299. ISSN 0098-7484.

• Ross, Joseph S.; Lehman, Richard; Gross, Cary P. (1 March 2012). "The Importance of Clinical Trial Data Sharing Toward More Open Science". Circulation: Cardiovascular Quality and Outcomes. 5 (2): 238–240. doi:10.1161/CIRCOUTCOMES.112.965798. ISSN 1941-7705.

• Krumholz, Harlan M. (1 March 2012). "Open Science and Data Sharing in Clinical Research Basing Informed Decisions on the Totality of the Evidence". Circulation: Cardiovascular Quality and Outcomes. 5 (2): 141–142. doi:10.1161/CIRCOUTCOMES.112.965848. ISSN 1941-7705.

• Krumholz, Harlan M.; Ross, Joseph S. (12 October 2011). "A Model for Dissemination and Independent Analysis of Industry Data". JAMA. 306 (14): 1593. doi:10.1001/jama.2011.1459. ISSN 0098-7484.