TY - JOUR AU - Clarke, M. J. PY - 2005 DA - 2005// TI - Individual patient data meta-analyses JO - Best Pract Res Clin Obstet Gynaecol VL - 19 UR - https://doi.org/10.1016/j.bpobgyn.2004.10.011 DO - 10.1016/j.bpobgyn.2004.10.011 ID - Clarke2005 ER - TY - BOOK AU - Cooper, H. M. AU - Hedges, L. V. AU - Valentine, J. C. PY - 2009 DA - 2009// TI - The handbook of research synthesis and meta-analysis PB - Russell Sage Foundation xvi CY - New York ID - Cooper2009 ER - TY - JOUR AU - Riley, R. D. AU - Simmonds, M. C. AU - Look, M. P. PY - 2007 DA - 2007// TI - Evidence synthesis combining individual patient data and aggregate data: a systematic review identified current practice and possible methods JO - J Clin Epidemiol VL - 60 UR - https://doi.org/10.1016/j.jclinepi.2006.09.009 DO - 10.1016/j.jclinepi.2006.09.009 ID - Riley2007 ER - TY - JOUR AU - Riley, R. D. AU - Lambert, P. C. AU - Abo-Zaid, G. PY - 2010 DA - 2010// TI - Meta-analysis of individual participant data: rationale, conduct, and reporting JO - BMJ VL - 340 UR - https://doi.org/10.1136/bmj.c221 DO - 10.1136/bmj.c221 ID - Riley2010 ER - TY - JOUR AU - Simmonds, M. C. PY - 2005 DA - 2005// TI - Meta-analysis of individual patient data from randomized trials: a review of methods used in practice JO - Clin Trials VL - 2 UR - https://doi.org/10.1191/1740774505cn087oa DO - 10.1191/1740774505cn087oa ID - Simmonds2005 ER - TY - JOUR AU - Tudur Smith, C. PY - 2011 DA - 2011// TI - Individual participant data meta-analyses compared with meta-analyses based on aggregate data [abstract] JO - Trials VL - 12 UR - https://doi.org/10.1186/1745-6215-12-21 DO - 10.1186/1745-6215-12-21 ID - Tudur Smith2011 ER - TY - JOUR AU - Stewart, L. A. AU - Clarke, M. J. PY - 1995 DA - 1995// TI - Practical methodology of meta-analyses (overviews) using updated individual patient data. Cochrane Working Group JO - Stat Med VL - 14 UR - https://doi.org/10.1002/sim.4780141902 DO - 10.1002/sim.4780141902 ID - Stewart1995 ER - TY - JOUR AU - Stewart, L. A. AU - Tierney, J. F. PY - 2002 DA - 2002// TI - To IPD or not to IPD? Advantages and disadvantages of systematic reviews using individual patient data JO - Eval Health Prof VL - 25 UR - https://doi.org/10.1177/0163278702025001006 DO - 10.1177/0163278702025001006 ID - Stewart2002 ER - TY - JOUR AU - Tudur Smith, C. PY - 2016 DA - 2016// TI - Individual participant data meta-analyses compared with meta-analyses based on aggregate data JO - Cochrane Database Syst Rev VL - 9 ID - Tudur Smith2016 ER - TY - JOUR AU - Lyman, G. H. AU - Kuderer, N. M. PY - 2005 DA - 2005// TI - The strengths and limitations of meta-analyses based on aggregate data JO - BMC Med Res Methodol VL - 5 UR - https://doi.org/10.1186/1471-2288-5-14 DO - 10.1186/1471-2288-5-14 ID - Lyman2005 ER - TY - JOUR AU - Mello, M. M. PY - 2013 DA - 2013// TI - Preparing for responsible sharing of clinical trial data JO - N Engl J Med VL - 369 UR - https://doi.org/10.1056/NEJMhle1309073 DO - 10.1056/NEJMhle1309073 ID - Mello2013 ER - TY - STD TI - Stewart LA, T.J., Clarke M. Chapter 18: Reviews of individual patient data. In: Higgins JPT, Green S (editors), Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011; Available from: www.handbook.cochrane.org. UR - http://www.handbook.cochrane.org ID - ref12 ER - TY - JOUR AU - Vale, C. L. PY - 2015 DA - 2015// TI - Uptake of systematic reviews and meta-analyses based on individual participant data in clinical practice guidelines: descriptive study JO - BMJ VL - 350 UR - https://doi.org/10.1136/bmj.h1088 DO - 10.1136/bmj.h1088 ID - Vale2015 ER - TY - JOUR AU - Tierney, J. F. PY - 2015 DA - 2015// TI - How individual participant data meta-analyses have influenced trial design, conduct, and analysis JO - J Clin Epidemiol VL - 68 UR - https://doi.org/10.1016/j.jclinepi.2015.05.024 DO - 10.1016/j.jclinepi.2015.05.024 ID - Tierney2015 ER - TY - STD TI - Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA (editors). Cochrane Handbook for Systematic Reviews of Interventions version 6.0 (updated July 2019). Cochrane, 2019. Available from www.training.cochrane.org/handbook. UR - http://www.training.cochrane.org/handbook ID - ref15 ER - TY - JOUR AU - Nevitt, S. J. PY - 2017 DA - 2017// TI - Exploring changes over time and characteristics associated with data retrieval across individual participant data meta-analyses: systematic review JO - BMJ VL - 357 UR - https://doi.org/10.1136/bmj.j1390 DO - 10.1136/bmj.j1390 ID - Nevitt2017 ER - TY - JOUR AU - Coady, S. A. PY - 2017 DA - 2017// TI - Use of the National Heart, Lung, and Blood Institute data repository JO - N Engl J Med VL - 376 UR - https://doi.org/10.1056/NEJMsa1603542 DO - 10.1056/NEJMsa1603542 ID - Coady2017 ER - TY - JOUR AU - Huang, Y. PY - 2014 DA - 2014// TI - Distribution and epidemiological characteristics of published individual patient data meta-analyses JO - PLoS One VL - 9 UR - https://doi.org/10.1371/journal.pone.0100151 DO - 10.1371/journal.pone.0100151 ID - Huang2014 ER - TY - JOUR AU - Ahmed, I. AU - Sutton, A. J. AU - Riley, R. D. PY - 2012 DA - 2012// TI - Assessment of publication bias, selection bias, and unavailable data in meta-analyses using individual participant data: a database survey JO - BMJ VL - 344 UR - https://doi.org/10.1136/bmj.d7762 DO - 10.1136/bmj.d7762 ID - Ahmed2012 ER - TY - JOUR AU - Rathi, V. PY - 2012 DA - 2012// TI - Sharing of clinical trial data among trialists: a cross sectional survey JO - BMJ VL - 345 UR - https://doi.org/10.1136/bmj.e7570 DO - 10.1136/bmj.e7570 ID - Rathi2012 ER - TY - JOUR AU - Sutton, A. J. AU - Kendrick, D. AU - Coupland, C. A. PY - 2008 DA - 2008// TI - Meta-analysis of individual- and aggregate-level data JO - Stat Med VL - 27 UR - https://doi.org/10.1002/sim.2916 DO - 10.1002/sim.2916 ID - Sutton2008 ER - TY - JOUR AU - Abo-Zaid, G. AU - Sauerbrei, W. AU - Riley, R. D. PY - 2012 DA - 2012// TI - Individual participant data meta-analysis of prognostic factor studies: state of the art? JO - BMC Med Res Methodol VL - 12 UR - https://doi.org/10.1186/1471-2288-12-56 DO - 10.1186/1471-2288-12-56 ID - Abo-Zaid2012 ER - TY - JOUR AU - Jaspers, G. J. AU - Degraeuwe, P. L. PY - 2014 DA - 2014// TI - A failed attempt to conduct an individual patient data meta-analysis JO - Syst Rev VL - 3 UR - https://doi.org/10.1186/2046-4053-3-97 DO - 10.1186/2046-4053-3-97 ID - Jaspers2014 ER - TY - JOUR AU - Tenopir, C. PY - 2015 DA - 2015// TI - Changes in data sharing and data reuse practices and perceptions among scientists worldwide JO - PLoS One VL - 10 UR - https://doi.org/10.1371/journal.pone.0134826 DO - 10.1371/journal.pone.0134826 ID - Tenopir2015 ER - TY - JOUR AU - Rathi, V. K. PY - 2014 DA - 2014// TI - Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey JO - Trials VL - 15 UR - https://doi.org/10.1186/1745-6215-15-384 DO - 10.1186/1745-6215-15-384 ID - Rathi2014 ER - TY - JOUR AU - Ross, J. S. PY - 2016 DA - 2016// TI - Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis JO - Syst Rev VL - 5 UR - https://doi.org/10.1186/s13643-016-0334-1 DO - 10.1186/s13643-016-0334-1 ID - Ross2016 ER - TY - JOUR AU - Ohmann, C. PY - 2017 DA - 2017// TI - Sharing and reuse of individual participant data from clinical trials: principles and recommendations JO - BMJ Open VL - 7 UR - https://doi.org/10.1136/bmjopen-2017-018647 DO - 10.1136/bmjopen-2017-018647 ID - Ohmann2017 ER - TY - JOUR AU - Barnhart, K. T. AU - Legro, R. S. AU - Scott, R. T. PY - 2018 DA - 2018// TI - Data sharing requirements: perspectives from three authors JO - Fertil Steril VL - 109 UR - https://doi.org/10.1016/j.fertnstert.2017.11.034 DO - 10.1016/j.fertnstert.2017.11.034 ID - Barnhart2018 ER - TY - JOUR AU - Sardanelli, F. PY - 2018 DA - 2018// TI - To share or not to share? Expected pros and cons of data sharing in radiological research JO - Eur Radiol VL - 28 UR - https://doi.org/10.1007/s00330-017-5165-5 DO - 10.1007/s00330-017-5165-5 ID - Sardanelli2018 ER - TY - JOUR AU - Wu, T. PY - 2018 DA - 2018// TI - Transparency and sharing individual participant data of clinical trials: a philosophical proposition about the medical study ethics and implications for clinical trials. [Chinese] JO - Chin J Evid Based Med VL - 18 ID - Wu2018 ER - TY - JOUR AU - Vickers, A. J. PY - 2016 DA - 2016// TI - Sharing raw data from clinical trials: what progress since we first asked “Whose data set is it anyway?” JO - Trials VL - 17 UR - https://doi.org/10.1186/s13063-016-1369-2 DO - 10.1186/s13063-016-1369-2 ID - Vickers2016 ER - TY - JOUR AU - Bell, E. A. AU - Ohno-Machado, L. AU - Grando, M. A. PY - 2014 DA - 2014// TI - Sharing my health data: a survey of data sharing preferences of healthy individuals JO - AMIA Annu Symp Proc VL - 2014 ID - Bell2014 ER - TY - JOUR AU - Cheah, P. Y. PY - 2015 DA - 2015// TI - Perceived benefits, harms, and views about how to share data responsibly: a qualitative study of experiences with and attitudes toward data sharing among Research staff and community representatives in Thailand JO - J Empir Res Hum Res Ethics VL - 10 UR - https://doi.org/10.1177/1556264615592388 DO - 10.1177/1556264615592388 ID - Cheah2015 ER - TY - JOUR AU - Howe, N. PY - 2018 DA - 2018// TI - Systematic review of participants’ attitudes towards data sharing: a thematic synthesis JO - J Health Serv Res Policy VL - 23 UR - https://doi.org/10.1177/1355819617751555 DO - 10.1177/1355819617751555 ID - Howe2018 ER - TY - JOUR AU - Mello, M. M. AU - Lieou, V. AU - Goodman, S. N. PY - 2018 DA - 2018// TI - Clinical trial participants’ views of the risks and benefits of data sharing JO - N Engl J Med VL - 378 UR - https://doi.org/10.1056/NEJMsa1713258 DO - 10.1056/NEJMsa1713258 ID - Mello2018 ER - TY - BOOK PY - 2014 DA - 2014// TI - European Medicines Agency policy on publication of clinical data for medicinal products for human use ID - ref36 ER - TY - BOOK PY - 2013 DA - 2013// TI - Availability of Masked and De-identified Non-Summary Safety and Efficacy Data; Request for Comments ID - ref37 ER - TY - JOUR AU - Taichman, D. B. PY - 2017 DA - 2017// TI - Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors JO - PLoS Med VL - 14 UR - https://doi.org/10.1371/journal.pmed.1002315 DO - 10.1371/journal.pmed.1002315 ID - Taichman2017 ER - TY - STD TI - Cancer Research UK. Submission of a data sharing and preservation strategy. 2009 June 1, 2015; Available from: http://www.cancerresearchuk.org/prod_consump/groups/cr_common/@fre/@gen/documents/generalcontent/cr_016308.pdf. Accessed 15 Apr 2020. UR - http://www.cancerresearchuk.org/prod_consump/groups/cr_common/@fre/@gen/documents/generalcontent/cr_016308.pdf ID - ref39 ER - TY - JOUR AU - Kiley, R. PY - 2017 DA - 2017// TI - Data sharing from clinical trials - a Research Funder's perspective JO - N Engl J Med VL - 377 UR - https://doi.org/10.1056/NEJMsb1708278 DO - 10.1056/NEJMsb1708278 ID - Kiley2017 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical Trials ID - ref41 ER - TY - JOUR AU - Godlee, F. AU - Groves, T. PY - 2012 DA - 2012// TI - The new BMJ policy on sharing data from drug and device trials JO - BMJ VL - 345 UR - https://doi.org/10.1136/bmj.e7888 DO - 10.1136/bmj.e7888 ID - Godlee2012 ER - TY - STD TI - PLOS Medicine. PLOS editorial and publishing policies; Available from: http://www.plosmedicine.org/static/policies.action;jsessionid=0CD27C4DE9841485620ED21B9E815D54#sharing. [cited 2014 July 1]. UR - http://www.plosmedicine.org/static/policies.action;jsessionid=0CD27C4DE9841485620ED21B9E815D54#sharing ID - ref43 ER - TY - STD TI - Scientific Data. Welcome to Scientific Data; Available from: http://www.nature.com/sdata/about. [cited 2014 July 1]. UR - http://www.nature.com/sdata/about ID - ref44 ER - TY - JOUR AU - Loder, E. AU - Groves, T. PY - 2015 DA - 2015// TI - The BMJ requires data sharing on request for all trials JO - BMJ VL - 350 UR - https://doi.org/10.1136/bmj.h2373 DO - 10.1136/bmj.h2373 ID - Loder2015 ER - TY - JOUR AU - Fletcher, J. PY - 2014 DA - 2014// TI - New CMAJ policy on sharing data from clinical research JO - CMAJ VL - 186 UR - https://doi.org/10.1503/cmaj.140041 DO - 10.1503/cmaj.140041 ID - Fletcher2014 ER - TY - BOOK PY - 2013 DA - 2013// TI - Principles for resposible clinical trial data sharing: Our commitment to patients and researchers ID - ref47 ER - TY - JOUR AU - Atzor, S. PY - 2014 DA - 2014// TI - Clinical trial data sharing: from principles to practical implementation - an industry model JO - Regul Rapporteur VL - 11 ID - Atzor2014 ER - TY - JOUR AU - Lo, B. PY - 2015 DA - 2015// TI - Sharing clinical trial data: maximizing benefits, minimizing risk JO - JAMA VL - 313 UR - https://doi.org/10.1001/jama.2015.292 DO - 10.1001/jama.2015.292 ID - Lo2015 ER - TY - JOUR AU - O'Dowd, A. PY - 2013 DA - 2013// TI - Drug industry pledge on access to trial data is met with scepticism JO - BMJ VL - 347 UR - https://doi.org/10.1136/bmj.f4829 DO - 10.1136/bmj.f4829 ID - O'Dowd2013 ER - TY - JOUR AU - Doshi, P. PY - 2013 DA - 2013// TI - EFPIA-PhRMA's principles for clinical trial data sharing have been misunderstood JO - BMJ VL - 347 UR - https://doi.org/10.1136/bmj.f5164 DO - 10.1136/bmj.f5164 ID - Doshi2013 ER - TY - STD TI - Clinical Study Data Request. Study sponsors; Available from: https://www.clinicalstudydatarequest.com/Study-Sponsors.aspx. [cited 2014 July 4]. UR - https://www.clinicalstudydatarequest.com/Study-Sponsors.aspx ID - ref52 ER - TY - BOOK PY - 2014 DA - 2014// TI - Clinical trials data and information sharing ID - ref53 ER - TY - BOOK PY - 2019 DA - 2019// TI - Clinical Trial Transparency, Data Sharing and Disclosure Practices ID - ref54 ER - TY - BOOK PY - 2018 DA - 2018// TI - About Astellas Clinical Study Results ID - ref55 ER - TY - STD TI - Bayer. Clinical trial transparency policy; Available from: http://pharma.bayer.com/en/innovation-partnering/clinical-trials/transparency-policy/. [cited 2019 March 12]. UR - http://pharma.bayer.com/en/innovation-partnering/clinical-trials/transparency-policy/ ID - ref56 ER - TY - BOOK PY - 2018 DA - 2018// TI - Biogen clinical trial transparency and data sharing policy ID - ref57 ER - TY - STD TI - Boehringer-Ingelheim. Policy on transparency and publication of clinical study data: Registration of clinical studies, disclosure of results in publications and results databases and access to study data and documents; Available from: https://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/documents/Policy.pdf. [cited 2019 March 12]. UR - https://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/documents/Policy.pdf ID - ref58 ER - TY - BOOK PY - 2018 DA - 2018// TI - Disclosure Commitment ID - ref59 ER - TY - BOOK PY - 2019 DA - 2019// TI - Clinical trials data sharing ID - ref60 ER - TY - STD TI - Eisai Co. Ltd. Clinical trial disclosure; Available from: https://www.eisai.com/company/business/research/clinical/index.html. [cited 2019 March 12]. UR - https://www.eisai.com/company/business/research/clinical/index.html ID - ref61 ER - TY - BOOK PY - 2014 DA - 2014// TI - Lilly announces increased access to clinical trials data for qualified researchers ID - ref62 ER - TY - BOOK PY - 2018 DA - 2018// TI - Our Commitment to Responsible Clinical Trial Data Sharing ID - ref63 ER - TY - BOOK PY - 2013 DA - 2013// TI - GSK gives update on plans to share detailed clinical trial data as part of its commitment to transparency ID - ref64 ER - TY - BOOK PY - 2019 DA - 2019// TI - We are committed to data transparency ID - ref65 ER - TY - BOOK PY - 2019 DA - 2019// TI - Data access requests ID - ref66 ER - TY - BOOK PY - 2019 DA - 2019// TI - Clinical trials and results: Our data sharing commitments ID - ref67 ER - TY - BOOK PY - 2017 DA - 2017// TI - Our commitment to transparency ID - ref68 ER - TY - BOOK PY - 2015 DA - 2015// TI - A Tradition of Serving Patients With Integrity ID - ref69 ER - TY - BOOK PY - 2014 DA - 2014// TI - UCB position statement on clinical study data transparency ID - ref70 ER - TY - BOOK PY - 2018 DA - 2018// TI - Johnson & Johnson - Available Data ID - ref71 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical trial data transparency ID - ref72 ER - TY - BOOK PY - 2018 DA - 2018// TI - Procedure on access to clinical trial data ID - ref73 ER - TY - BOOK PY - 2018 DA - 2018// TI - Review process for data sharing ID - ref74 ER - TY - STD TI - Roche. Roche global policy on sharing of clincal study information; Available from: https://www.roche.com/dam/jcr:1c46aa73-cea0-4b9b-8eaa-e9a788ed021b/en/roche_global_policy_on_sharing_of_clinical_study_information.pdf. [cited 2019 March 13]. UR - https://www.roche.com/dam/jcr:1c46aa73-cea0-4b9b-8eaa-e9a788ed021b/en/roche_global_policy_on_sharing_of_clinical_study_information.pdf ID - ref75 ER - TY - BOOK PY - 2020 DA - 2020// TI - Project Data Sphere ID - ref76 ER - TY - JOUR AU - Schunemann, H. J. PY - 2016 DA - 2016// TI - Use of heparins in patients with cancer: individual participant data meta-analysis of randomised trials study protocol JO - BMJ Open VL - 6 UR - https://doi.org/10.1136/bmjopen-2015-010569 DO - 10.1136/bmjopen-2015-010569 ID - Schunemann2016 ER - TY - BOOK PY - 2018 DA - 2018// TI - How to request data ID - ref78 ER - TY - JOUR AU - Tricco, A. C. PY - 2018 DA - 2018// TI - PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation JO - Ann Intern Med VL - 169 UR - https://doi.org/10.7326/M18-0850 DO - 10.7326/M18-0850 ID - Tricco2018 ER - TY - BOOK PY - 2019 DA - 2019// TI - Our members ID - ref80 ER - TY - BOOK PY - 2020 DA - 2020// TI - Home ID - ref81 ER - TY - BOOK PY - 2020 DA - 2020// TI - PhRMA ID - ref82 ER - TY - BOOK PY - 2018 DA - 2018// TI - Sharing clinical trial information ID - ref83 ER - TY - BOOK PY - 2017 DA - 2017// TI - PhRMA Principles for Responsible Clinical Trial Data Sharing – Certifications ID - ref84 ER - TY - BOOK PY - 2019 DA - 2019// TI - Sponsor Specific Details: Astellas ID - ref85 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical trial data sharing ID - ref86 ER - TY - JOUR AU - Nisen, P. AU - Rockhold, F. PY - 2013 DA - 2013// TI - Access to patient-level data from GlaxoSmithKline clinical trials JO - N Engl J Med VL - 369 UR - https://doi.org/10.1056/NEJMsr1302541 DO - 10.1056/NEJMsr1302541 ID - Nisen2013 ER - TY - BOOK PY - 2014 DA - 2014// TI - Data transparency ID - ref88 ER - TY - BOOK PY - 2016 DA - 2016// TI - Novartis Position on Clinical Study Transparency – Clinical Study Registration, Results Reporting and Data Sharing ID - ref89 ER - TY - BOOK PY - 2018 DA - 2018// TI - Disclosure of Clinical Study Data ID - ref90 ER - TY - STD TI - Yale University Open Data Access (YODA) Project. How to request data; Available from: https://yoda.yale.edu/how-request-data. [cited 2019 March 13]. UR - https://yoda.yale.edu/how-request-data ID - ref91 ER - TY - BOOK PY - 2014 DA - 2014// TI - Johnson & Johnson Announces Clinical Trial Data Sharing Agreement with Yale School of Medicine ID - ref92 ER - TY - BOOK AU - Krumholz, H. M. PY - 2014 DA - 2014// TI - Give the data to the people ID - Krumholz2014 ER - TY - BOOK PY - 2019 DA - 2019// TI - Biogen clinical trial transparency and data sharing policy ID - ref94 ER - TY - BOOK PY - 2017 DA - 2017// TI - Clinical trial data sharing policy ID - ref95 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical Trial Information Disclosure ID - ref96 ER - TY - BOOK PY - 2014 DA - 2014// TI - Clinical Trials Data Access - Independent Review Panel Charter ID - ref97 ER - TY - BOOK PY - 2018 DA - 2018// TI - AstraZeneca Group of Companies – Data Request Portal ID - ref98 ER - TY - BOOK AU - Andrews, N. PY - 2015 DA - 2015// TI - AstraZeneca Clinical Trial Transparency and External Sharing of Individual Patient-Level Data ID - Andrews2015 ER - TY - BOOK PY - 2019 DA - 2019// TI - Disclosure Commitment ID - ref100 ER - TY - JOUR AU - Pencina, M. J. PY - 2016 DA - 2016// TI - Supporting open access to clinical trial data for researchers: the Duke Clinical Research Institute-Bristol-Myers Squibb supporting open access to researchers initiative JO - Am Heart J VL - 172 UR - https://doi.org/10.1016/j.ahj.2015.11.002 DO - 10.1016/j.ahj.2015.11.002 ID - Pencina2016 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical trial transparency statement ID - ref102 ER - TY - STD TI - EMD Serono. Responsible data sharing instruction document; Available from: https://www.emdgroup.com/content/dam/web/corporate/non-images/business-specifics/healthcare/US/Responsible_Data_Sharing_Instruction_Document_US.pdf. [cited 2019 April 18]. UR - https://www.emdgroup.com/content/dam/web/corporate/non-images/business-specifics/healthcare/US/Responsible_Data_Sharing_Instruction_Document_US.pdf ID - ref103 ER - TY - BOOK PY - 2018 DA - 2018// TI - User Registration ID - ref104 ER - TY - BOOK PY - 2018 DA - 2018// TI - Datasharing ID - ref105 ER - TY - STD TI - Regeneron. Clinical Trial Disclosure & Data Transparency Policy Statements; Available from: https://errs.regeneron.com/external/DefaultBU1.aspx. [cited 2020 March 18]. UR - https://errs.regeneron.com/external/DefaultBU1.aspx ID - ref106 ER - TY - BOOK PY - 2018 DA - 2018// TI - Data request portal ID - ref107 ER - TY - BOOK PY - 2019 DA - 2019// TI - Clinical trials ID - ref108 ER - TY - BOOK PY - 2019 DA - 2019// TI - Clinical Trial Data Sharing Request ID - ref109 ER - TY - BOOK PY - 2014 DA - 2014// TI - Transparency ID - ref110 ER - TY - BOOK PY - 2018 DA - 2018// TI - Clinical data sharing with researchers ID - ref111 ER - TY - STD TI - Leo Pharma. LEO Pharma's Position on Public Access to Clinical Trials Information. Available from: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/LEO-Pharmas-position-on-transparency.aspx. [cited 2019 March 14]. UR - http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/LEO-Pharmas-position-on-transparency.aspx ID - ref112 ER - TY - STD TI - Leo Pharma. How to get access to anonymised patient-level data. Available from: http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx#Step_1:__Fasibility_assessment_by_LEO_Pharma. [cited 2019 March 14]. UR - http://www.leo-pharma.com/Home/Research-and-Development/Clinical-trial-disclosure/Access-to-patient-level-data.aspx#Step_1:__Fasibility_assessment_by_LEO_Pharma ID - ref113 ER - TY - BOOK PY - 2018 DA - 2018// TI - Policy for scientific publications and responsible clinical trial data sharing ID - ref114 ER - TY - STD TI - Novo Nordisk. How to access clinical trial datasets. Available from: https://www.novonordisk-trials.com/how-access-clinical-trial-datasets. [cited 2019 March 14]. UR - https://www.novonordisk-trials.com/how-access-clinical-trial-datasets ID - ref115 ER - TY - STD TI - Novo Nordisk. Independent review board charter. Available from: https://www.novonordisk-trials.com/sites/novonordisk/themes/novo/img/document/Independent%20Review%20Board%20Charter.pdf. [cited 2019 March 14]. UR - https://www.novonordisk-trials.com/sites/novonordisk/themes/novo/img/document/Independent%20Review%20Board%20Charter.pdf ID - ref116 ER - TY - STD TI - Orion Corporation. Ethics in the Clinical Research Phase. Available from: https://www.orion.fi/en/Orion-group/Sustainability/policies/pharmaceutical-rd-ethics-policy/ethics-in-clinical-research/. [cited 2019 March 14]. UR - https://www.orion.fi/en/Orion-group/Sustainability/policies/pharmaceutical-rd-ethics-policy/ethics-in-clinical-research/ ID - ref117 ER - TY - BOOK PY - 2019 DA - 2019// TI - For researchers: Overview of researcher access to patient-level data ID - ref118 ER - TY - BOOK PY - 2018 DA - 2018// TI - Responsibility highlights report 2017 ID - ref119 ER - TY - BOOK PY - 2018 DA - 2018// TI - Review of requests ID - ref120 ER - TY - STD TI - Clinical Study Data Request. Independent review panel charter. Available from: https://clinicalstudydatarequest.com/Documents/Independent_Review_Panel_Charter.pdf. [cited 2018 August 1]. UR - https://clinicalstudydatarequest.com/Documents/Independent_Review_Panel_Charter.pdf ID - ref121 ER - TY - BOOK PY - 2019 DA - 2019// TI - Biogen ID - ref122 ER - TY - BOOK PY - 2017 DA - 2017// TI - Bristol-Myers Squibb data sharing independent review committee (IRC) charter ID - ref123 ER - TY - STD TI - EMD Serono. Summary of EMD Serono's responsible data sharing policy. [cited 2019 March 22]. ID - ref124 ER - TY - BOOK PY - 2018 DA - 2018// TI - Requesting access to clinical data ID - ref125 ER - TY - BOOK PY - 2016 DA - 2016// TI - Procedures to Guide External Investigator Access to Clinical Trial Data ID - ref126 ER - TY - BOOK PY - 2020 DA - 2020// TI - Regeneron Mission Statement & Purpose of Investigator-Initiated Study Program ID - ref127 ER - TY - JOUR AU - Berlin, J. A. PY - 2014 DA - 2014// TI - Bumps and bridges on the road to responsible sharing of clinical trial data JO - Clin Trials VL - 11 UR - https://doi.org/10.1177/1740774513514497 DO - 10.1177/1740774513514497 ID - Berlin2014 ER - TY - JOUR AU - Polanin, J. R. PY - 2018 DA - 2018// TI - Efforts to retrieve individual participant data sets for use in a meta-analysis result in moderate data sharing but many data sets remain missing JO - J Clin Epidemiol VL - 98 UR - https://doi.org/10.1016/j.jclinepi.2017.12.014 DO - 10.1016/j.jclinepi.2017.12.014 ID - Polanin2018 ER - TY - JOUR AU - Polanin, J. R. AU - Terzian, M. PY - 2019 DA - 2019// TI - A data-sharing agreement helps to increase researchers’ willingness to share primary data: results from a randomized controlled trial JO - J Clin Epidemiol VL - 106 UR - https://doi.org/10.1016/j.jclinepi.2018.10.006 DO - 10.1016/j.jclinepi.2018.10.006 ID - Polanin2019 ER - TY - JOUR AU - Polanin, J. R. AU - Williams, R. T. PY - 2016 DA - 2016// TI - Overcoming obstacles in obtaining individual participant data for meta-analysis JO - Res Synth Methods VL - 7 UR - https://doi.org/10.1002/jrsm.1208 DO - 10.1002/jrsm.1208 ID - Polanin2016 ER - TY - STD TI - Tierney JF, Vale C, Riley R, Smith CT, Stewart L, Clarke M, et al. Individual Participant Data (IPD) Meta-analyses of Randomised Controlled Trials: Guidance on Their Use. PLoS Med. 2015;12(7):e1001855. https://doi.org/10.1371/journal.pmed.1001855. Accessed 15 Apr 2020. ID - ref132 ER - TY - JOUR AU - Veroniki, A. A. PY - 2016 DA - 2016// TI - Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial JO - Trials VL - 17 UR - https://doi.org/10.1186/s13063-016-1238-z DO - 10.1186/s13063-016-1238-z ID - Veroniki2016 ER - TY - JOUR AU - Young, T. AU - Hopewell, S. PY - 2011 DA - 2011// TI - Methods for obtaining unpublished data JO - Cochrane Database Syst Rev VL - 11 ID - Young2011 ER - TY - STD TI - Lefebvre C, M.E., Glanville J. Chapter 6: Searching for studies In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011; Available from: www.handbook.cochrane.org. UR - http://www.handbook.cochrane.org ID - ref135 ER - TY - JOUR AU - Wolfe, N. AU - Gotzsche, P. C. AU - Bero, L. PY - 2013 DA - 2013// TI - Strategies for obtaining unpublished drug trial data: a qualitative interview study JO - Syst Rev VL - 2 UR - https://doi.org/10.1186/2046-4053-2-31 DO - 10.1186/2046-4053-2-31 ID - Wolfe2013 ER - TY - JOUR AU - Veroniki, A. A. PY - 2019 DA - 2019// TI - Retrieval of individual patient data depended on study characteristics: a randomized controlled trial JO - J Clin Epidemiol VL - 113 UR - https://doi.org/10.1016/j.jclinepi.2019.05.031 DO - 10.1016/j.jclinepi.2019.05.031 ID - Veroniki2019 ER - TY - STD TI - Clinical Study Data Request. Our mission. 2019; Available from: https://clinicalstudydatarequest.com/Default.aspx. [cited 2019 April 1]. UR - https://clinicalstudydatarequest.com/Default.aspx ID - ref138 ER - TY - JOUR AU - Murugiah, K. PY - 2016 DA - 2016// TI - Availability of clinical trial data from industry-sponsored cardiovascular trials JO - J Am Heart Assoc VL - 5 UR - https://doi.org/10.1161/JAHA.116.003307 DO - 10.1161/JAHA.116.003307 ID - Murugiah2016 ER - TY - BOOK PY - 2019 DA - 2019// TI - DARS guidance ID - ref140 ER - TY - BOOK PY - 2019 DA - 2019// TI - Data Access Request Service (DARS): process ID - ref141 ER - TY - BOOK PY - 2019 DA - 2019// TI - Metrics ID - ref142 ER - TY - JOUR AU - Geifman, N. PY - 2015 DA - 2015// TI - Opening clinical trial data: Are the voluntary data-sharing portals enough? JO - BMC Med VL - 13 UR - https://doi.org/10.1186/s12916-015-0525-y DO - 10.1186/s12916-015-0525-y ID - Geifman2015 ER - TY - BOOK PY - 2019 DA - 2019// TI - Members ID - ref144 ER - TY - BOOK PY - 2019 DA - 2019// TI - Membership ID - ref145 ER - TY - JOUR AU - Hopkins, A. M. AU - Rowland, A. AU - Sorich, M. J. PY - 2018 DA - 2018// TI - Data sharing from pharmaceutical industry sponsored clinical studies: Audit of data availability JO - BMC Med VL - 16 UR - https://doi.org/10.1186/s12916-018-1154-z DO - 10.1186/s12916-018-1154-z ID - Hopkins2018 ER - TY - BOOK PY - 2017 DA - 2017// TI - EFPIA-PHRMA Princples for responsible clinical trial data sharing report on the 2016 member company survey. ID - ref147 ER - TY - BOOK PY - 2019 DA - 2019// TI - 2018 Progress Report ID - ref148 ER - TY - JOUR AU - Chan, A. W. PY - 2014 DA - 2014// TI - Increasing value and reducing waste: addressing inaccessible research JO - Lancet VL - 383 UR - https://doi.org/10.1016/S0140-6736(13)62296-5 DO - 10.1016/S0140-6736(13)62296-5 ID - Chan2014 ER - TY - JOUR AU - Doshi, P. AU - Goodman, S. N. AU - Ioannidis, J. P. PY - 2013 DA - 2013// TI - Raw data from clinical trials: within reach? JO - Trends Pharmacol Sci VL - 34 UR - https://doi.org/10.1016/j.tips.2013.10.006 DO - 10.1016/j.tips.2013.10.006 ID - Doshi2013 ER - TY - JOUR AU - Gotzsche, P. C. PY - 2011 DA - 2011// TI - Why we need easy access to all data from all clinical trials and how to accomplish it JO - Trials VL - 12 UR - https://doi.org/10.1186/1745-6215-12-249 DO - 10.1186/1745-6215-12-249 ID - Gotzsche2011 ER - TY - JOUR AU - Ross, J. S. AU - Krumholz, H. M. PY - 2013 DA - 2013// TI - Ushering in a new era of open science through data sharing: the wall must come down JO - JAMA VL - 309 UR - https://doi.org/10.1001/jama.2013.1299 DO - 10.1001/jama.2013.1299 ID - Ross2013 ER - TY - JOUR AU - Fecher, B. AU - Friesike, S. AU - Hebing, M. PY - 2015 DA - 2015// TI - What drives academic data sharing? JO - PLoS One VL - 10 UR - https://doi.org/10.1371/journal.pone.0118053 DO - 10.1371/journal.pone.0118053 ID - Fecher2015 ER - TY - JOUR PY - 2013 DA - 2013// TI - Advancing Science Through Collaborative Data Sharing and Synthesis JO - Perspect Psychol Sci VL - 8 UR - https://doi.org/10.1177/1745691613491579 DO - 10.1177/1745691613491579 ID - ref154 ER - TY - JOUR AU - Sydes, M. R. AU - Ashby, D. PY - 2017 DA - 2017// TI - Data authorship as an incentive to data sharing JO - N Engl J Med VL - 377 UR - https://doi.org/10.1056/NEJMc1707245 DO - 10.1056/NEJMc1707245 ID - Sydes2017 ER - TY - JOUR AU - Bierer, B. E. AU - Crosas, M. AU - Pierce, H. H. PY - 2017 DA - 2017// TI - Data authorship as an incentive to data sharing JO - N Engl J Med VL - 377 UR - https://doi.org/10.1056/NEJMc1707245 DO - 10.1056/NEJMc1707245 ID - Bierer2017 ER - TY - JOUR AU - Berman, F. AU - Cerf, V. PY - 2013 DA - 2013// TI - Science priorities. Who will pay for public access to research data? JO - Science VL - 341 UR - https://doi.org/10.1126/science.1241625 DO - 10.1126/science.1241625 ID - Berman2013 ER - TY - JOUR AU - Wilhelm, E. E. AU - Oster, E. AU - Shoulson, I. PY - 2014 DA - 2014// TI - Approaches and costs for sharing clinical research data JO - JAMA VL - 311 UR - https://doi.org/10.1001/jama.2014.850 DO - 10.1001/jama.2014.850 ID - Wilhelm2014 ER - TY - JOUR AU - Zhu, C. S. PY - 2017 DA - 2017// TI - Data sharing in clinical trials: an experience with two large cancer screening trials JO - PLoS Med VL - 14 UR - https://doi.org/10.1371/journal.pmed.1002304 DO - 10.1371/journal.pmed.1002304 ID - Zhu2017 ER - TY - JOUR AU - Naudet, F. PY - 2018 DA - 2018// TI - Data sharing and reanalysis of randomized controlled trials in leading biomedical journals with a full data sharing policy: Survey of studies published in the BMJ and PLOS Medicine JO - BMJ VL - 360 UR - https://doi.org/10.1136/bmj.k400 DO - 10.1136/bmj.k400 ID - Naudet2018 ER - TY - BOOK AU - Bobrow, M. PY - 2014 DA - 2014// TI - Establishing incentives and changing cultures to support data access ID - Bobrow2014 ER - TY - JOUR AU - Rockhold, F. AU - Nisen, P. AU - Freeman, A. PY - 2016 DA - 2016// TI - Data sharing at a crossroads JO - N Engl J Med VL - 375 UR - https://doi.org/10.1056/NEJMp1608086 DO - 10.1056/NEJMp1608086 ID - Rockhold2016 ER - TY - JOUR AU - Kaiser, J. PY - 2018 DA - 2018// TI - A new portal for patient data JO - Science VL - 361 UR - https://doi.org/10.1126/science.361.6399.212 DO - 10.1126/science.361.6399.212 ID - Kaiser2018 ER - TY - JOUR AU - Tucker, K. PY - 2016 DA - 2016// TI - Protecting patient privacy when sharing patient-level data from clinical trials JO - BMC Med Res Methodol VL - 16 UR - https://doi.org/10.1186/s12874-016-0169-4 DO - 10.1186/s12874-016-0169-4 ID - Tucker2016 ER - TY - JOUR AU - Tudur Smith, C. PY - 2015 DA - 2015// TI - How should individual participant data (IPD) from publicly funded clinical trials be shared? JO - BMC Med VL - 13 UR - https://doi.org/10.1186/s12916-015-0532-z DO - 10.1186/s12916-015-0532-z ID - Tudur Smith2015 ER - TY - BOOK PY - 2018 DA - 2018// TI - External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use ID - ref166 ER - TY - JOUR AU - Mazor, K. M. PY - 2017 DA - 2017// TI - Stakeholders’ views on data sharing in multicenter studies JO - J Comp Eff Res VL - 6 UR - https://doi.org/10.2217/cer-2017-0009 DO - 10.2217/cer-2017-0009 ID - Mazor2017 ER - TY - JOUR AU - Panhuis, W. G. PY - 2014 DA - 2014// TI - A systematic review of barriers to data sharing in public health JO - BMC Public Health VL - 14 UR - https://doi.org/10.1186/1471-2458-14-1144 DO - 10.1186/1471-2458-14-1144 ID - Panhuis2014 ER - TY - BOOK AU - Bobrow, M. PY - 2014 DA - 2014// TI - Establishing incentives and changing cultures to support data access ID - Bobrow2014 ER - TY - JOUR AU - Bull, S. AU - Roberts, N. AU - Parker, M. PY - 2015 DA - 2015// TI - Views of ethical best practices in sharing individual-level data from medical and public Health Research: a systematic scoping review JO - J Empir Res Hum Res Ethics VL - 10 UR - https://doi.org/10.1177/1556264615594767 DO - 10.1177/1556264615594767 ID - Bull2015 ER - TY - JOUR AU - Rowhani-Farid, A. AU - Allen, M. AU - Barnett, A. G. PY - 2017 DA - 2017// TI - What incentives increase data sharing in health and medical research? A systematic review JO - Res Integr Peer Rev VL - 2 UR - https://doi.org/10.1186/s41073-017-0028-9 DO - 10.1186/s41073-017-0028-9 ID - Rowhani-Farid2017 ER - TY - JOUR AU - Kim, Y. PY - 2017 DA - 2017// TI - Fostering scientists’ data sharing behaviors via data repositories, journal supplements, and personal communication methods JO - Inf Process Manag VL - 53 UR - https://doi.org/10.1016/j.ipm.2017.03.003 DO - 10.1016/j.ipm.2017.03.003 ID - Kim2017 ER - TY - JOUR AU - Hopkins, C. PY - 2016 DA - 2016// TI - UK publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns JO - J Clin Epidemiol VL - 70 UR - https://doi.org/10.1016/j.jclinepi.2015.07.002 DO - 10.1016/j.jclinepi.2015.07.002 ID - Hopkins2016 ER - TY - STD TI - Learned K, Durbin A, Currie R, Beale H, Lam DL, Goldstein T, Salama SR, Haussler D, Morozova O, Bjork I. A critical evaluation of genomic data sharing: Barriers to accessing pediatric cancer genomic datasets: a Treehouse Childhood Cancer Initiative experience [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017. Washington, DC. Philadelphia (PA): AACR; Cancer Res. 2017;77(13 Suppl):Abstract nr LB-338. https://doi.org/10.1158/1538-7445.AM2017-LB-338. ID - ref174 ER - TY - JOUR AU - Simmonds, M. AU - Stewart, G. AU - Stewart, L. PY - 2015 DA - 2015// TI - A decade of individual participant data meta-analyses: A review of current practice JO - Contemp Clin Trials VL - 45 UR - https://doi.org/10.1016/j.cct.2015.06.012 DO - 10.1016/j.cct.2015.06.012 ID - Simmonds2015 ER - TY - JOUR AU - Debray, T. P. PY - 2015 DA - 2015// TI - Get real in individual participant data (IPD) meta-analysis: a review of the methodology JO - Res Synth Methods VL - 6 UR - https://doi.org/10.1002/jrsm.1160 DO - 10.1002/jrsm.1160 ID - Debray2015 ER - TY - JOUR AU - Rogozinska, E. PY - 2017 DA - 2017// TI - Meta-analysis using individual participant data from randomised trials: opportunities and limitations created by access to raw data JO - Evidence-Based Med VL - 22 UR - https://doi.org/10.1136/ebmed-2017-110775 DO - 10.1136/ebmed-2017-110775 ID - Rogozinska2017 ER - TY - JOUR AU - Stewart, L. A. PY - 2015 DA - 2015// TI - Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD statement JO - JAMA VL - 313 UR - https://doi.org/10.1001/jama.2015.3656 DO - 10.1001/jama.2015.3656 ID - Stewart2015 ER - TY - BOOK PY - 2014 DA - 2014// TI - SAS Clinical Trial Data Transparency ID - ref179 ER - TY - BOOK PY - 2018 DA - 2018// TI - Multi-Sponsor Environment - SAS® Clinical Trial Data Transparency Version 2.3 User Guide ID - ref180 ER - TY - STD TI - Clinical Study Data Request. Access to Data 2018; Available from: https://clinicalstudydatarequest.com/Help/Help-Access-to-Data.aspx. [cited 2018 August 1]. UR - https://clinicalstudydatarequest.com/Help/Help-Access-to-Data.aspx ID - ref181 ER - TY - JOUR AU - Mospan, G. A. AU - Wargo, K. A. PY - 2016 DA - 2016// TI - Researchers’ experience with clinical data sharing JO - J Am Board Fam Med VL - 29 UR - https://doi.org/10.3122/jabfm.2016.06.160198 DO - 10.3122/jabfm.2016.06.160198 ID - Mospan2016 ER - TY - JOUR AU - Mbuagbaw, L. PY - 2017 DA - 2017// TI - Challenges to complete and useful data sharing JO - Trials VL - 18 UR - https://doi.org/10.1186/s13063-017-1816-8 DO - 10.1186/s13063-017-1816-8 ID - Mbuagbaw2017 ER - TY - JOUR AU - Aitken, M. PY - 2016 DA - 2016// TI - Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies JO - BMC Med Ethics VL - 17 UR - https://doi.org/10.1186/s12910-016-0153-x DO - 10.1186/s12910-016-0153-x ID - Aitken2016 ER - TY - JOUR AU - Hughes, S. PY - 2014 DA - 2014// TI - Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach JO - Pharm Stat VL - 13 UR - https://doi.org/10.1002/pst.1615 DO - 10.1002/pst.1615 ID - Hughes2014 ER - TY - STD TI - Committee on Strategies for Responsible Sharing of Clinical Trial Data, Board on Health Sciences Policy, and Institute of Medicine. Sharing clinical trial data: maximizing benefits, minimizing risk. Washington (DC): National Academies Press (US); 2015 Appendix B, Concepts and Methods for De-identifying Clinical Trial Data]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK285994/. UR - https://www.ncbi.nlm.nih.gov/books/NBK285994/ ID - ref186 ER - TY - JOUR AU - Emam, K. E. AU - Rodgers, S. AU - Malin, B. PY - 2015 DA - 2015// TI - Anonymising and sharing individual patient data JO - BMJ VL - 350 UR - https://doi.org/10.1136/bmj.h1139 DO - 10.1136/bmj.h1139 ID - Emam2015 ER - TY - JOUR AU - Tierney, J. F. PY - 2015 DA - 2015// TI - Individual participant data (IPD) meta-analyses of randomised controlled trials: guidance on their use JO - PLoS Med VL - 12 UR - https://doi.org/10.1371/journal.pmed.1001855 DO - 10.1371/journal.pmed.1001855 ID - Tierney2015 ER - TY - JOUR AU - Hollis, S. PY - 2016 DA - 2016// TI - Best practice for analysis of shared clinical trial data JO - BMC Med Res Methodol VL - 16 UR - https://doi.org/10.1186/s12874-016-0170-y DO - 10.1186/s12874-016-0170-y ID - Hollis2016 ER - TY - BOOK PY - 2014 DA - 2014// TI - About AllTrials ID - ref190 ER - TY - BOOK PY - 2014 DA - 2014// TI - Data transparency ID - ref191 ER - TY - JOUR AU - Simmonds, M. C. PY - 2013 DA - 2013// TI - Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data JO - Ann Intern Med VL - 158 UR - https://doi.org/10.7326/0003-4819-158-12-201306180-00005 DO - 10.7326/0003-4819-158-12-201306180-00005 ID - Simmonds2013 ER - TY - JOUR AU - Fu, R. PY - 2013 DA - 2013// TI - Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis JO - Ann Intern Med VL - 158 UR - https://doi.org/10.7326/0003-4819-158-12-201306180-00006 DO - 10.7326/0003-4819-158-12-201306180-00006 ID - Fu2013 ER - TY - JOUR AU - Krumholz, H. M. PY - 2013 DA - 2013// TI - A historic moment for open science: the Yale University open data access project and medtronic JO - Ann Intern Med VL - 158 UR - https://doi.org/10.7326/0003-4819-158-12-201306180-00009 DO - 10.7326/0003-4819-158-12-201306180-00009 ID - Krumholz2013 ER - TY - JOUR AU - Hrobjartsson, A. PY - 2013 DA - 2013// TI - Why did it take 19 months to retrieve clinical trial data from a non-profit organisation? JO - BMJ VL - 347 UR - https://doi.org/10.1136/bmj.f6927 DO - 10.1136/bmj.f6927 ID - Hrobjartsson2013 ER - TY - JOUR AU - Savage, C. J. AU - Vickers, A. J. PY - 2009 DA - 2009// TI - Empirical study of data sharing by authors publishing in PLoS journals JO - PLoS One VL - 4 UR - https://doi.org/10.1371/journal.pone.0007078 DO - 10.1371/journal.pone.0007078 ID - Savage2009 ER - TY - JOUR AU - Filippon, J. PY - 2015 DA - 2015// TI - Slow and costly access to anonymised patient data impedes academic research JO - BMJ VL - 351 UR - https://doi.org/10.1136/bmj.h5087 DO - 10.1136/bmj.h5087 ID - Filippon2015 ER - TY - JOUR AU - Tudur Smith, C. PY - 2014 DA - 2014// TI - Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository JO - PLoS One VL - 9 UR - https://doi.org/10.1371/journal.pone.0097886 DO - 10.1371/journal.pone.0097886 ID - Tudur Smith2014 ER - TY - JOUR AU - Huser, V. AU - Shmueli-Blumberg, D. PY - 2018 DA - 2018// TI - Data sharing platforms for de-identified data from human clinical trials JO - Clinical Trials VL - 15 UR - https://doi.org/10.1177/1740774518769655 DO - 10.1177/1740774518769655 ID - Huser2018 ER - TY - JOUR AU - So, D. AU - Knoppers, B. M. PY - 2017 DA - 2017// TI - Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com JO - PLoS One VL - 12 UR - https://doi.org/10.1371/journal.pone.0184491 DO - 10.1371/journal.pone.0184491 ID - So2017 ER - TY - JOUR AU - Sydes, M. R. PY - 2015 DA - 2015// TI - Sharing data from clinical trials: The rationale for a controlled access approach JO - Trials VL - 16 UR - https://doi.org/10.1186/s13063-015-0604-6 DO - 10.1186/s13063-015-0604-6 ID - Sydes2015 ER - TY - JOUR AU - Green, A. K. PY - 2015 DA - 2015// TI - The project data sphere initiative: accelerating cancer research by sharing data JO - Oncologist VL - 20 UR - https://doi.org/10.1634/theoncologist.2014-0431 DO - 10.1634/theoncologist.2014-0431 ID - Green2015 ER - TY - JOUR AU - Eichler, H. G. AU - Sweeney, F. PY - 2018 DA - 2018// TI - The evolution of clinical trials: Can we address the challenges of the future? JO - Clin Trials VL - 15 UR - https://doi.org/10.1177/1740774518755058 DO - 10.1177/1740774518755058 ID - Eichler2018 ER - TY - JOUR AU - Khusro, A. AU - Aarti, C. PY - 2017 DA - 2017// TI - TB-PACTS: a fresh emphatic data sharing approach JO - Asian Pac J Trop Dis VL - 7 UR - https://doi.org/10.12980/apjtd.7.2017D6-357 DO - 10.12980/apjtd.7.2017D6-357 ID - Khusro2017 ER - TY - JOUR AU - Bertagnolli, M. M. PY - 2017 DA - 2017// TI - Advantages of a truly open-access data-sharing model JO - N Engl J Med VL - 376 UR - https://doi.org/10.1056/NEJMsb1702054 DO - 10.1056/NEJMsb1702054 ID - Bertagnolli2017 ER - TY - JOUR AU - Asare, A. L. PY - 2016 DA - 2016// TI - Clinical trial data access: opening doors with TrialShare JO - J Allergy Clin Immunol VL - 138 UR - https://doi.org/10.1016/j.jaci.2016.05.034 DO - 10.1016/j.jaci.2016.05.034 ID - Asare2016 ER - TY - JOUR AU - Zinner, D. E. AU - Pham-Kanter, G. AU - Campbell, E. G. PY - 2016 DA - 2016// TI - The changing nature of scientific sharing and withholding in academic life sciences Research: trends from National Surveys in 2000 and 2013 JO - Acad Med VL - 91 UR - https://doi.org/10.1097/ACM.0000000000001028 DO - 10.1097/ACM.0000000000001028 ID - Zinner2016 ER - TY - JOUR AU - Rowhani-Farid, A. AU - Barnett, A. G. PY - 2016 DA - 2016// TI - Has open data arrived at the British medical journal (BMJ)? An observational study JO - BMJ Open VL - 6 UR - https://doi.org/10.1136/bmjopen-2016-011784 DO - 10.1136/bmjopen-2016-011784 ID - Rowhani-Farid2016 ER - TY - JOUR AU - Strom, B. L. PY - 2016 DA - 2016// TI - Data sharing - is the juice worth the squeeze? JO - N Engl J Med VL - 375 UR - https://doi.org/10.1056/NEJMp1610336 DO - 10.1056/NEJMp1610336 ID - Strom2016 ER - TY - JOUR AU - Bonini, S. PY - 2014 DA - 2014// TI - Transparency and the European medicines agency--sharing of clinical trial data JO - N Engl J Med VL - 371 UR - https://doi.org/10.1056/NEJMp1409464 DO - 10.1056/NEJMp1409464 ID - Bonini2014 ER - TY - JOUR AU - Drazen, J. M. PY - 2015 DA - 2015// TI - Sharing individual patient data from clinical trials JO - N Engl J Med VL - 372 UR - https://doi.org/10.1056/NEJMp1415160 DO - 10.1056/NEJMp1415160 ID - Drazen2015 ER - TY - JOUR PY - 2016 DA - 2016// TI - Toward Fairness in Data Sharing JO - N Engl J Med VL - 375 UR - https://doi.org/10.1056/NEJMp1605654 DO - 10.1056/NEJMp1605654 ID - ref212 ER - TY - JOUR AU - Navar, A. M. AU - Pencina, M. J. AU - Peterson, E. D. PY - 2016 DA - 2016// TI - Open access platforms for sharing clinical trial data--reply JO - JAMA VL - 316 UR - https://doi.org/10.1001/jama.2016.8797 DO - 10.1001/jama.2016.8797 ID - Navar2016 ER - TY - JOUR AU - Ross, J. S. AU - Krumholz, H. M. PY - 2016 DA - 2016// TI - Open access platforms for sharing clinical trial data JO - JAMA VL - 316 UR - https://doi.org/10.1001/jama.2016.8794 DO - 10.1001/jama.2016.8794 ID - Ross2016 ER - TY - JOUR AU - Navar, A. M. PY - 2016 DA - 2016// TI - Use of open access platforms for clinical trial data JO - JAMA VL - 315 UR - https://doi.org/10.1001/jama.2016.2374 DO - 10.1001/jama.2016.2374 ID - Navar2016 ER - TY - JOUR AU - Garrison, N. A. PY - 2016 DA - 2016// TI - A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States JO - Genet Med VL - 18 UR - https://doi.org/10.1038/gim.2015.138 DO - 10.1038/gim.2015.138 ID - Garrison2016 ER - TY - BOOK PY - 2019 DA - 2019// TI - Aegerion Pharmaceuticals ID - ref217 ER - TY - BOOK PY - 2014 DA - 2014// TI - Commitment letter ID - ref218 ER - TY - BOOK PY - 2019 DA - 2019// TI - Transparency and trust ID - ref219 ER - TY - BOOK PY - 2020 DA - 2020// TI - Vivli Platform Process at a Glance ID - ref220 ER -