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

Journal article title page for Incentivizing a new culture of data stewardship the NIH policy for data management and sharing

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

Journal article title page for national institutes of health plan for increasing access to scientific publications and digital scientific data from NIH funded scientific researchta

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

Journal article title page for sharing health data the why, the will and the way forward

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.

Journal article title page for 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.

Journal image for Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk

Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC, The National Academies Press, 2015.

Journal article title page for discussion framework for clinical trial data sharing

Institute of Medicine. Discussion Framework for Clinical Trial Data Sharing: Guiding Principles, Elements, and Activities. Washington, DC, The National Academies Press, 2014.

Journal article title page for 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

Journal article title page for finding means to fulfull 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.

Journal article title page for 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.

Journal article title page for 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.

Journal article title page for trial reporting in CT.gov

Zarin DA, Tse T, Williams RJ, Carr S. Trial Reporting in ClinialTrials.gov- The Final Rule. NEJM. 2016; 375:1998-2004.

Journal article title page for clinical trial publishing game, the economist

The Economist. Clinical Trial Publishing Game. October 6, 2015.

Journal article title page for funders data policies

University of Bath. Funders’ data policies.

Journal article title page for Preferred reporting items for a systematic review and meta-analysis of IPD data

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.

Journal article title page for rationale for WHO's new position calling for prompt reporting and public disclosure of interventional clinical trials 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.

Journal article title page for clinical trial data: share and share alike?

Mitka M. Clinical Trial Data: Share and Share Alike? JAMA. 2015;313:881-882.

Journal article title page for the proposed for U.S clinical trial registration

Zarin DA, Tse T, Sheehan J. The Proposed Rule for U.S. Clinical Trial Registration and Results Submission. NEJM. 2015;372:174-180.

Journal article title page for european medicines agency on publication of clinical data for medicinal products

European Medicines Agency. European Medicines Agency policy on publication of clinical data for medicinal products for human use: POLICY/0070. October 2, 2014.

Journal article title page for assessing the research potential of access to clinical trial data

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.

Journal article title page for transparency and 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.

Journal article title page for 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.

Journal article title page for raw data from clinical trials within reach

Doshi P, Goodman SN, Ioannidis JA. Raw Data from Clinical Trials: Within Reach? Trends Pharm Sci. 2013;34:645-647.

Journal article title page for Principles for responsible clinical trial data sharing

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.

Journal article title page for the first 2 years of the European Medicine Agency's

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.

Journal article title page for making raw data more widely available

Vickers AJ. Making Raw Data More Widely Available. BMJ. 2011;342:d2323.

Journal article title page for european med agency policy on access to docs

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

Journal cover page for establishing a basis for secondary use

Odame E, Burgess T, Arbuckle L, Belcin A, et al. Establishing a Basis for Secondary Use Standards for Clinical Trials. Applied Clinical Trials. 2023.

Journal article title page for the challenges of open access data

Brayne C, et al. The Challenges of Open Access Data. The Lancet. 2022; 399.10324:517.

Journal article title page for 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]

Journal article title page for sharing clinical research data

Lo B, Goodman SN. Sharing Clinical Research Data- Finding the Right Balance. JAMA Int Med. 2017:177;1241-1242.

Journal article title page for resource implications of preparing IPD 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.

Journal article title page for a manifesto for reproducible science

Munafo MR, Nosek BA, Bishop DVM, et al. A Manifesto for Reproducible Science. Nature Human Behaviour. 2017;1:1-9.

Journal article title page for collab for alzheimers preventation

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.

Journal article title page for good principles for sharing IPD from publicly funded 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.

Journal article title page for anonymizing and sharing IPD

El Emam K, Rodgers S, Malin B. Anonymising and Sharing Individual Patient Data. BMJ. 2015;350:h1139.

Journal article title page for sharing data from clinical trials: 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.

Journal article title page for fostering responsible data sharing through standards

Kush R, Goldman M. Fostering Responsible Data Sharing through Standards. NEJM. 2014;370:2163-2165.

Journal article title page for 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.

Journal article title page for increasing value and reducing water in research design

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.

Journal article title page for 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.

Journal article title page for 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.

Journal article title page for how should clinical trial data be shared

Tucker M. How Should Clinical Trial Data be Shared? BMJ. 2013;347:f4465.

Journal article title page for open clinical trial data

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.

Journal article title page for 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.

Journal article title page for preparing raw clinical data for publication

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.

Journal article title page for 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.

Journal article title page for towards a data sharing culture: recs 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

Journal article title page for measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharma 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.

Journal article title page for clinical trial registration, reporting, publication and FDAAA compliance;a cross sectionall analysis and ranking of new drugs

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.

Journal article title page for authors report lact of time as a main reason for unpublished research

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.

Journal article title page for uptake of systematic reviews and meta analysis based on IPD in clinical practice guidelines

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.

Journal article title page for 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.

Journal article title page for non publication and delayed publication of randomized trials on vaccines

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.

Journal article title page for participant level data and the new frontier

Zarin DA. Participant-Level Data and the New Frontier in Trial Transparency. NEJM. 2013;369:468-469.

Journal article title page for access to patient level trial data

Eichler HG, Pétavy F, Pignatti F, Rasi G. Access to Patient-Level Trial Data- A Boon to Drug Developers. NEJM. 2013;369:1577-1579.

Journal article title page for rethinkin reanalysis

Christakis DA, Zimmerman FJ. Rethinking Reanalysis. JAMA. 2013;310:2499-2500.

Journal article title page for clinical trials as a public good

Rodwin MA, Abramson JD. Clinical Trial Data as a Public Good. JAMA. 2012;308:871-872.

Journal article title page for strenghening 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.

Journal article title page for 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.

Journal article title page for 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.

Journal article title page for empirical study of data sharing by authose publishing in PLoS journals

Savage CJ, Vickers AJ. Empirical Study of Data Sharing by Authors Publishing in PLoS Journals. PLoS ONE. 2009;4:e7078.

Journal article title page for 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.

Journal article title page for whose data set is it anyway?

Vickers AJ. Whose Data Set Is It Anyway? Sharing Raw Data from Randomized Trials. Trials. 2006;7:15.

Patient Perspective

Journal article title page for Clinical trial participants' views of the risk 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.

Journal article title page for I’m a patient: show me the trial data

Lomas A. I’m a Patient: Show Me the Trial Data. BMJ. 2013;346:f2336.