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Relevant Literature

The YODA Project recommends the following articles for those interested in learning more about the data sharing field. Many of these articles aided in the development of the YODA Project policies and procedures. This is not intended to be a comprehensive list, and additional resources will be added over time.

NIH Data Sharing Resources

Incentivizing a New Culture of Data Stewardship- The NIH Policy for Data Management and Sharing
NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources NIH Sharing Policies and Related Guidance on NIH-Funded Research Resources
Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research Plan for Increasing Access to Scientific Publications and Digital Scientific Data from NIH Funded Scientific Research
NIH Data Sharing Repositories NIH Data Sharing Repositories

National Academy of Medicine

Greene SM, Ahmed M, Chua PS, and Grossmann C, Editors. 2021.
Sharing Health Data: The Why, the Will, and the Way Forward. NAM Special Publication. Washington, DC: National Academy of Medicine.
IOM Reflections on Sharing Clinical Trial Data National Academies of Sciences, Engineering, and Medicine. Reflections on Sharing Clinical Trial Data: Challenges and a Way Forward: Proceedings of a Workshop. Washington, DC: The National Academies Press, 2020.
Maximizing Benefits, Minimizing Risk Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC, The National Academies Press, 2015.
Guiding Principles, Elements, and Activities Institute of Medicine. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC, The National Academies Press, 2014.
Vaccine Safety Research, Data Access, and Public Trust Institute of Medicine. Vaccine Safety Research, Data Access, and Public Trust. Washington, DC, The National Academies Press, 2005.

Data Sharing Policies and Progress

Finding Means to Fulfill the Societal and Academic Imperative for Open Data Access and Sharing Peterson ED, Rockhold FW. Finding Means to Fulfill the Societal and Academic Imperative for Open Data Access and Sharing. JAMA Cardiol. [Epub ahead of print 2018 Jul 3] doi: 10.1001/jamacardio.2018.0129.
Moving From Hope to Hard Work in Data Sharing Gibson CM. Moving From Hope to Hard Work in Data Sharing. JAMA Cardiol. [Epub ahead of print 2018 Jul 3] doi: 10.1001/jamacardio.2018.0130.
Data Sharing-The Time Has (Not Yet?) Come Yancy CW, Harrington RA, Bonow RO. Data Sharing-The Time Has (Not Yet?) Come. JAMA Cardiol. [Epub ahead of print 2018 Jul 3]. doi: 10.1001/jamacardio.2018.1939.
 
Trial Reporting in ClinialTrials.gov- The Final Rule Zarin DA, Tse T, Williams RJ, Carr S. Trial Reporting in ClinialTrials.gov- The Final Rule. NEJM. 2016; 375:1998-2004.
Clinical Trial Publishing Game The Economist. Clinical Trial Publishing Game. October 6, 2015.
Funders' data policies University of Bath. Funders’ data policies.
The PRISMA-IPD Statement Stewart LA, Clarke M, Rovers M, Riley RD, Simmonds M, Stewart G, Tierney JF. Preferred Reporting Items for a Systematic Review and Meta-analysis of Individual Participant Data: The PRISMA-IPD Statement. JAMA. 2015;313:1657-1665.
Rationale for WHO's New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results Moorthy VS, Karam G, Vannice KS, Kieny M. Rationale for WHO’s New Position Calling for Prompt Reporting and Public Disclosure of Interventional Clinical Trial Results. PLOS Med. 2015;12.
Share and Share Alike? Mitka M. Clinical Trial Data: Share and Share Alike? JAMA. 2015;313:881-882.
The Proposed Rule for U.S. Clinical Trial Registration and Results Submission Zarin DA, Tse T, Sheehan J. The Proposed Rule for U.S. Clinical Trial Registration and Results Submission. NEJM. 2015;372:174-180.
POLICY/0070 European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use: POLICY/0070. October 2, 2014.
Assessing the research potential of access to clinical trial data. A report to the Wellcome Trust Varnai P, Rentel MC, Simmonds P, Sharp TA, Mostert B, de Jongh, T. Assessing the research potential of access to clinical trial data.  A report to the Wellcome Trust. Study led by Technopolis Group (UK), 2014.
Transparency and the European Medicines Agency- Sharing of Clinical Trial Data Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency- Sharing of Clinical Trial Data. NEJM. 2014;371:2452-2455.
The European Medicines Agency and the Brave New World of Access to Clinical Trial Data Steinbrook R. The European Medicines Agency and the Brave New World of Access to Clinical Trial Data. JAMA Intern Med. 2013;173:373-374.
Within Reach? Doshi P, Goodman SN, Ioannidis JA. Raw Data from Clinical Trials: Within Reach? Trends Pharm Sci. 2013;34:645-647.
Our Commitment to Patients and Researchers Pharmaceutical Research and Manufacturers of America [PhRMA] and European Federation of Pharmaceutical Industries and Associations [EFPIA]. Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers. July 18, 2013.
Secret No Longer Doshi P, Jefferson T. The First 2 Years of the European Medicines Agency’s Policy on Access to Documents: Secret No Longer. JAMA Intern Med. 2013;173:380-382.
Making Raw Data More Widely Available Vickers AJ. Making Raw Data More Widely Available. BMJ. 2011;342:d2323.
POLICY/0043 European Medicines Agency. European Medicines Agency policy on access to documents (related to medicinal products for human and veterinary use): POLICY/0043. November 30, 2010.

Approaches to Data Sharing

Brayne C, et al. The Challenges of Open Access Data. The Lancet. 2022; 399.10324:517. 
Data Sharing and Embedded Research Simon GE, Coronado G, DeBar LL, et al. Data Sharing and Embedded Research. Annals Int Med. 2017. [epub ahead of print]
Sharing Clinical Research Data- Finding the Right Balance Lo B, Goodman SN. Sharing Clinical Research Data- Finding the Right Balance. JAMA Int Med. 2017:177;1241-1242.
Resource Implications of Preparing Individual Participant Data from a Clinical Trial to Share with External Researchers Tudur Smith C, Nevitt S, Appelbe D, et al. Resource Implications of Preparing Individual Participant Data from a Clinical Trial to Share with External Researchers. Trials. 2017;18:319-326.
A Manifesto for Reproducible Science. Nature Human Behaviour Munafo MR, Nosek BA, Bishop DVM, et al. A Manifesto for Reproducible Science. Nature Human Behaviour. 2017;1:1-9.
Principles to Guide Data and Sample Sharing in Preclinical Alzheimer’s Disease Trials Weninger S, Carrillo MC, Dunn B, et al. Collaboration for Alzheimer’s Prevention: Principles to Guide Data and Sample Sharing in Preclinical Alzheimer’s Disease Trials. Alzheimers Dement. 2016;12:631-632.
Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials Tudur Smith C, Hopkins C, Sydes M, Woolfall K, Clarke M, Murray G, Williamson P. Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials. April 2015.
Anonymising and Sharing Individual Patient Data El Emam K, Rodgers S, Malin B. Anonymising and Sharing Individual Patient Data. BMJ. 2015;350:h1139.
The Rationale for a Controlled Access Approach Sydes MR, Johnson AL, Meredith SK, Rauchenberger M, South A, Parmar MKB. Sharing Data from Clinical Trials: The Rationale for a Controlled Access Approach. Trials. 2015;16:104.
Fostering Responsible Data Sharing through Standards Kush R, Goldman M. Fostering Responsible Data Sharing through Standards. NEJM. 2014;370:2163-2165.
Approaches and Costs for Sharing Clinical Research Data Wilhelm EE, Oster E, Shoulson I. Approaches and Costs for Sharing Clinical Research Data. JAMA. 2014;311:1201-1202.
Increasing Value and Reducing Waste in Research Design, Conduct, and Analysis Ioannidis JA, Greenland S, Hlatky MA, Khoury MJ, Macleod MR, Moher D, Schulz KF, Tibshirani R. Increasing Value and Reducing Waste in Research Design, Conduct, and Analysis. Lancet. 2014;383:166-175.
Preparing for Responsible Sharing of Clinical Trial Data Mello MM, Francer JK, Wilenzick M, Teden P, Bierer BE, Barnes M. Preparing for Responsible Sharing of Clinical Trial Data. NEJM. 2013;369:1651-1658.
Who Will Pay for Public Access to Research Data Berman F, Cerf V. Who Will Pay for Public Access to Research Data? Science. 2013;341:616-617.
How Should Clinical Trial Data be Shared Tucker M. How Should Clinical Trial Data be Shared? BMJ. 2013;347:f4465.
Open Clinical Trial Data for All? A View from Regulators Eichler HG, Abadie E, Breckenridge A, Leufkens H, Rasi G. Open Clinical Trial Data for All? A View from Regulators. PLOS Med. 2012;9:e1001202.
The Double-Edged Sword of Open Access to Research Data Spertus JA. The Double-Edged Sword of Open Access to Research Data. Circ Cardiovasc Qual Outcomes. 2012;5:143-144.
Guidance for Journal Editors, Authors, and Peer Reviewers Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing Raw Clinical Data for Publication: Guidance for Journal Editors, Authors, and Peer Reviewers. BMJ. 2010;340:c181.
Towards Agreement on Best Practice for Publishing Raw Clinical Trial Data Hrynaszkiewicz I, Altman DG. Towards Agreement on Best Practice for Publishing Raw Clinical Trial Data. Trials. 2009;10:17.
Recommendations for Leadership from Academic Health Centers Piwowar HA, Becich MJ, Bilofsky H, Crowley RS. Towards a Data Sharing Culture: Recommendations for Leadership from Academic Health Centers. PLoS Med. 2008;5:e183.

Importance of Transparency

an empirical analysis of newly approved drugs and large pharmaceutical companies Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open. 2017;7:e017917.
a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012 Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open. 2015;5:e009758.
a Systematic Review Scherer RW, Ugarte-Gil C, Schmucker C, Meerpohl JJ. Authors Report Lack of Time as Main Reason for Unpublished Research Presented at Biomedical Conferences: a Systematic Review. J Clin Epidemiol. Epub February 13, 2015.
Descriptive Study Vale CL, Rydzewska LHM, Rovers MM, Emberson JR, Gueyffier F, Stewart LA. Uptake of Systematic Reviews and Meta-Analyses Based on Individual Participant Data in Clinical Practice Guidelines: Descriptive Study. BMJ. 2015;350:h1088.
Reanalyses of Randomized Clinical Trial Data Ebrahim S, Sohani ZN, Montoya L, Agarwal A, Thorlund K, Mills EJ, Ioannidis JA. Reanalyses of Randomized Clinical Trial Data. JAMA. 2014;312:1024-1032.
Survey Manzoli L, Flacco ME, D’Addario M, Capasso L, De Vito C, Marzuillo C, Villari P, Ioannidis JA. Non-Publication and Delayed Publication of Randomized Trials on Vaccines: Survey. BMJ. 2014;348:g3058.
Participant-Level Data and the New Frontier in Trial Transparency Zarin DA. Participant-Level Data and the New Frontier in Trial Transparency. NEJM. 2013;369:468-469.
Access to Patient-Level Trial Data- A Boon to Drug Developers Eichler HG, Pétavy F, Pignatti F, Rasi G. Access to Patient-Level Trial Data- A Boon to Drug Developers. NEJM. 2013;369:1577-1579.
Rethinking Reanalysis Christakis DA, Zimmerman FJ. Rethinking Reanalysis. JAMA. 2013;310:2499-2500.
Clinical Trial Data as a Public Good Rodwin MA, Abramson JD. Clinical Trial Data as a Public Good. JAMA. 2012;308:871-872.
Strengthening and Opening Up Health Research by Sharing Our Raw Data Gøtzsche PC. Strengthening and Opening Up Health Research by Sharing Our Raw Data. Circ Cardiovasc Qual Outcomes. 2012;5:236-237.
Public Availability of Published Research Data in High-Impact Journals Alsheikh-Ali AA, Qureshi W, Al-Mallah MH, Ioannidis JA. Public Availability of Published Research Data in High-Impact Journals. PLOS One. 2011;6:e24357.
Why We Need Easy Access to All Data from All Clinical Trials and How to Accomplish it Gøtzsche PC. Why We Need Easy Access to All Data from All Clinical Trials and How to Accomplish it. Trials. 2011;12:249.
Empirical Study of Data Sharing by Authors Publishing in PLoS Journals Savage CJ, Vickers AJ. Empirical Study of Data Sharing by Authors Publishing in PLoS Journals. PLoS ONE. 2009;4:e7078.
Issues in the Registration of Clinical Trials Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DB. Issues in the Registration of Clinical Trials. JAMA. 2007;297:2112-2120.
Whose Data Set Is It Anyway? Sharing Raw Data from Randomized Trials Vickers AJ. Whose Data Set Is It Anyway? Sharing Raw Data from Randomized Trials. Trials. 2006;7:15.

Patient Perspective

Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing Mello MM, Lieou V, Goodman SN. Clinical Trial Participants’ Views of the Risks and Benefits of Data Sharing. NEJM. 2018; 378:2202-2211.
Show Me the Trial Data Lomas A. I’m a Patient: Show Me the Trial Data. BMJ. 2013;346:f2336.