Participant-level data and the new frontier in trial transparency
by Deborah A. ZarinWe have to learn as much as we can about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism.
Access to regulatory data from the European Medicines Agency: the times they are a-changing
by Beate Wieseler, Natalie McGauran, Michaela F Kerekes, Thomas Kaisera milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.
Data sharing: reaching consensus.
by Jimmy WhitworthJimmy Whitworth calls for a more sustainable and palatable pathway be will to build consensus and to create a broad coalition.
Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits
Whose data set is it anyway? Sharing raw data from randomized trials
by Andrew VickersIn this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically
A systematic review of barriers to data sharing in public health
by Willem G van Panhuis, Proma Paul, Claudia Emerson, John Grefenstette, Richard Wilder, Abraham J Herbst, David Heymann, Donald S BurkeThis study looks at the challneges of data sharing globally.
Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons
Prepublication data sharing
by Toronto International Data Release Workshop AuthorsRapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.
Sharing health data: developing country perspectives
by Viroj Tangcharoensathien, Jirawan Boonperm, Pongpisut JongudomsukSharing data is not only about the technical dimension such as data management, repositories and libraries; developing countries are concerned about factors that impede data sharing, in particular, fairness
Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data
by Strech D, Littmann JComparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.
The double-edged sword of open access to research data
by John A. SpertusJohn A. Spertus suggests that there needs to be some consideration about the practicalities of data sharing- in how it is shared, investment, and ensuring that data are appropriately analyzed
The delay in sharing research data is costing lives
by Josh SommerThis article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.
Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industry
by So D, Joly Y, Knoppers BMThis paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.
Increasing the accessibility of data
by Smith, G. D.This article looks at the benefits of data sharing, and argues for increasing the accessibility of data
Introduction: data sharing and disclosure limitation techniques
by Sieber, J. E.This article details the procedures and requirements for researchers in sharing data from clinical trials.
Characteristics desired in clinical data warehouse for biomedical research
by Soo-Yong Shin, Woo Sung Kim, Jae-Ho LeeThis article proposes some key characteristics needed in a clinical data warehouses for biomedical research
Sharing research data to improve public health: a perspective from the global south
by Osman Sankoh, Carel IJsselmuidenThis article asks the question: how do we achieve fair trade in the sharing of clinical data?
The International Stroke Trial database
by Peter AG Sandercock, Maciej Niewada, Anna Członkowska, the International Stroke Trial Collaborative GroupWe aimed to make individual patient data from the International Stroke Trial (IST), available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.
Ushering in a new era of open science through data sharing: the wall must come down
by Joseph S. Ross, Harlan M. KrumholzThis article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.
Promoting transparency in pharmaceutical industry-sponsored research
by Ross JS, Gross CP, Krumholz HMPolicies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators.
Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.
This study looks at the sharing of data between researchers; it details concerns about speed of reply, and highlights an unfortunate situation where researchers are more concerned with losing an advantage than advancing science.
Sharing of clinical trial data among trialists: a cross sectional survey
by Vinay Rathi, Kristina Dzara, Cary P Gross, Iain Hrynaszkiewicz, Steven Joffe, Harlan M Krumholz, Kelly M Strait, Joseph S RossThis article investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.
Improving health research governance and management in the Western Pacific: A WHO Expert Consultation
by Manju Rani, Hendrik Bekedam, Brian S. BuckleyWHO organised an expert consultation on research in the Western Pacific
A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committee
by Ramos EM, Din-Lovinescu C, Bookman EB, McNeil LJ, Baker CC, Godynskiy G, Harris EL, Lehner T, McKeon C, Moss J, Starks VL, Sherry ST, Manolio TA, Rodriguez LLThis article looks at how access to GAIN information has furthered advances in he understanding of the genetic underpinnings of mental-health disorders, diabetes, and psoriasis.
Drug watchdog ponders how to open clinical trial data vault
by Tania RabesandratanaEMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.
Towards a data sharing culture: recommendations for leadership from academic health centers
by Heather A Piwowar, Michael J Becich, Howard Bilofsky, Rebecca S CrowleyHeather A Piwowar proposes that AHCs can and should lead the transition towards a culture of biomedical data sharing.
Withholding access to research data - Authors' reply
by Elizabeth Pisani, James Whitworth, Basia Zaba, Carla AbouZahrThe Lancet suggests that transparency in science will increase public trust and reduce the deliberate manipulation of data to score political, financial, or ideological points.
Time for fair trade in research data
by Elizabeth Pisani, James Whitworth, Basia Zaba, Carla Abou-ZahrThis argues for all the positives of data sharing
In this round table paper, we suggest goals for data sharing and a work plan for reaching them, and challenge respondents to move beyond well intentioned but largely aspirational data sharing plans.
This article argues that it is inappropriate to prescribe exactly when or how researchers should preserve and share data.
Ethical data release in genome-wide association studies in developing countries
by Michael Parker, Susan J. Bull, Jantina de Vries, Tsiri Agbenyega, Ogobara K. Doumbo, Dominic P. KwiatkowskiThis article looks at the ethical problems involved in data sharing within the Genome-Wide Association Studies in Developing Countries
Access to patient-level data from GlaxoSmithKline clinical trials. New England Journal of Medicine
by Perry Nisen, Frank RockholdGSK reccently trailed the sharing of deidentified patient-level data. This article describes the approach adopted and answers some of the most common questions received
Preparing for responsible sharing of clinical trial data.
by Michelle M. Mello, Jeffrey K. Francer, Marc Wilenzick, Patricia Teden, Barbara E. Bierer, Mark BarnesThis article argues that expanded data sharing must be pursued thoughtfully.
Systematic archiving and access to health research data: rationale, current status and way forward.
by Manju Rani, Brian S BuckleyThis paper discusses important developments in data-sharing policy and highlights factors in health research that may affect policy implementation
Sharing data for public health: where is the vision?
by Alan D LopezThis article argues that WHO need to take leadership of the data sharing debate
Is there a duty to share? Ethics of sharing research data in the context of public health emergencies
by Pinky Langat, Dmitri Pisartchik, Diego Silva, Carrie Bernard, Kolby Olsen, Maxwell Smith, Sachin Sahni, Ross UpshurThis article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies.
Drug firms take legal steps to prevent European regulator releasing data
by Zosia KmietowiczA leading US pharmaceutical company, AbbVie, has taken legal action against Europe’s medicines regulator to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs.
Preparing individual patient data from clinical trials for sharing: The GlaxoSmithKline approach
by Hughes S, Wells K, McSorley P, Freeman A.This article describes how to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants.
Towards agreement on best practice for publishing raw clinical trial data
by Iain Hrynaszkiewicz, Douglas G AltmanThis article aims to address inadequate reporting in randomised controlled trials.
After a global push, cancer clinical trial data is to be shared.
Sharing of research data
by Donald J HarrisGeoffrey Boulton lays out the case for sharing scientific data, and advises that the UK's Royal Society has established a working group to examine the implementation issues and to make recommendations.
The BMJ Group and the Association of the British Pharmaceutical Industry conference discusses the dangers and promises of trial data
Time to mandate data release and independent audits for all clinical trials
by Haines IE, Gabor Miklos GLMedical journals should insist on the release of all raw data and a written independent clinical audit.
Strengthening and opening up health research by sharing our raw data
by Peter C. GøtzschePeter C. Gøtzsche's speech on the moral obligation and societal benefits of providing free access to all anonymized raw patient data from clinical research
Why we need easy access to all data from all clinical trials and how to accomplish it
by Gøtzsche PCGøtzsche argues that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests
We need access to all data from all clinical trials.
by Peter C GøtzschePeter Gøtzsche argues why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available
The BMj's new policy is a necessary first step towards the full sharing of all anonymised trial data
Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute
by Geller NL, Sorlie P, Coady S, Fleg J, Friedman LThis paper describes this policy as well as the limited access data sets currently available from NHLBI.
Redefining genomic privacy: trust and empowerment
by Yaniv Erlich, James B. Williams, David Glazer, Kenneth Yocum, Nita Farahany, Maynard Olson, Arvind Narayanan, Lincoln D. Stein, Jan A. Witkowski, Robert C. KainThis article suggests the use of trust-enabling techniques to create a solution in which researchers and participants both win with data sharing.
This article presents an overview of genetic privacy breaching strategies, and reviews potential mitigation methods for privacy-preserving dissemination of sensitive data and highlight different cases that are relevant to genetic applications.
Access to patient-level trial data--a boon to drug developers
by Hans-Georg Eichler, Frank Pétavy, Francesco Pignatti, Guido RasiThe EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.
Respectful re-use
by Nature GeneticsThe impact of the papers we publish depends increasingly on the data they describe. In insisting on data access for referees and readers, we prioritize scientific integrity above all and place the interests of research participants before impact.
Data sharing will pay dividends
by NatureAs public pressure builds for drug companies to make more results available from clinical trials, the industry should not forget that it relies on collective goodwill to test new therapies.
Towards an Ethics Safe Harbour for Global Breast Cancer Research. Current Oncology
by Edward S. Dove, Bartha M. Knoppers, Ma'n H. ZawatiThis article proposes a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles
Transparency interrupted: the curtailment of the European Medicines Agency's Policy on access to documents.
by Peter DoshiPeter Doshi looks at the curtailment of EMA’s policy on access to documents, which is rgues is a major step backward for the transparency of clinical trials and for public health.
Part III: Meeting the Challenge When Data Sharing Is Required
by de Wolf, V. A, Sieber, J. E, Steel, P. M, Zarate, A. OThe article describes several approaches that can be used in meeting the challenges posed by the sharing of confidential data.
Part II: HIPAA and Disclosure Risk Issues
by Virginia A. de Wolf, Joan E. Sieber, Philip M. Steel, Alvan O. ZarateThis guide looks at whether deidentification is sufficient in data sharing.
Part I: What Is the Requirement for Data Sharing?
by Virginia A. de Wolf, Joan E. Sieber, Philip M. Steel, Alvan O. ZarateThis article looks at rules and regulations for data sharing.
Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI
by Sean A Coady, Elizabeth WagnerThe National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB.
Editorial: Research data ownership and dissemination: is it too simple to suggest that 'possession is nine-tenths of the law
by Cleary, M, Jackson, D, Walter, GThis article argues that ownership of research data is a complex issue and warrents cafeful examination.
This article provides a description of the barriers to sharing in biobanking, discusses key themes, and concludes that empirical research is required to determine the full extent of the challenges addressed in the literature.
Increasing value and reducing waste: addressing inaccessible research
by Chan, A.-W, Song, F, Vickers, A, Jefferson, T, Dickersin, K, Gotzsche, P. C, Krumholz, H, Ghersi,D, van der Worp, H. BThis article looks at the problems caused by inaccessible data to journal reporting, finance and funding; it then looks at possible solutions.
Pediatric data sharing in genomic research: attitudes and preferences of parents
by Burstein, M. D, Robinson, J. O, Hilsenbeck, S. G, McGuire, A. L, Lau, C. C.The current study examines genomic research participants' attitudes to explore differences in data sharing preferences between parents of pediatric patients and adult patients.
Elizabeth Pisani and colleagues highlight obstacles to data sharing in public health. However, they omit a potentially crucial one: investigators manipulating evidence that might contradict their hypotheses or conclusions.
Data sharing in research: benefits and risks for clinicians
by Elliott AntmanElliot Antman explore issues surrounding data sharing in scientific research
This article looks at the problems of data sharing in clinical trials, data ownership and development of databases to enable safe sharing processes.
Collaboration which allows protocol build, data collection and data sharing via free and open access web support.
Strengthening Research through Data Sharing
by Elizabeth WarrenElizabeth Warren addresses the policy, privacy, and practical issues affecting data sharing in clinical trails.
Brigham and Women's Hospital–Harvard University's Multi-Regional Clinical Trials Center is designing a platform to link existing data-sharing platforms and communities and host data from investigators who want to share data but lack the resources to do so.
From Patient to Patient — Sharing the Data from Clinical Trials
by Charlotte J. HaugThis article asks the question: how — and how much — to share, where and in what format data should be stored and accessed, and how to protect the privacy of the trial participants.
Data sharing guidance for CRUK researchers initiatives and repositories to support clinical rseacrhers with data management and sharing contents
by Cancer research UKCancer Research UK highlights some key initiatives and repositories which may provide tools and guidance for data sharing in the academic clinical trial field.
Research Data Management and Sharing
by University of North CarolinaThe University of Carolina offers a free eLearning course about data management and sharing.
The ethics of 'Trials within Cohorts' (TWiCs) 2nd international symposium
by Relton C, Burbach M, Collett C, Flory J, Gerlich S, Holm S, Hunn A, Kim S, Kwakkenbos L, May A, Nicholl J, Young-Afat D, Treweek S, Uher R, Van Staa T, Van Der Velden J, Verkooijen H, Vickers A, Welch S, Zwarenstein MThe two-day symposium enabled an international group to meet and share experiences of the TwiCs design and to discuss plans for future research.
Research Data Oxford » Data management planning
by Research Data OxfordThe University of Oxford's tips for data management planning.
The ACDM represents professionals working in the management of clinical data
Open Access Policy Frequently Asked Questions - Bill & Melinda Gates Foundation
by Gates FoundationThe Bill and Melinda Gates foundation answers questions about their open access policy.
Data sharing statements for clinical trials
by Taichman D, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong S, Haileamlak A, Gollogly L, Godlee F, Frizelle F, Florenzano F, Drazen J, Bauchner H, Baethge C, Backus JThe ICMJE introduces it's vsion for a global research community in which sharing deidentified data becomes the norm.
A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritis
by Kirkham J, Clarke M, Williamson PThis study assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.
Guidelines for MRC research and management of data.
Pharmaceutical companies' policies on access to trial data, results, and methods: audit study
by Goldacre B, Lane S, Mahtani K, Heneghan C, Onakpoya I, Bushfield I, Smeeth LThis study looks at the commitments made by companies to transparency of trials.
Making research data repositories visible: The re3data.org registry
by Pampel H, Vierkant P, Scholze F, Bertelmann R, Kindling M, Klump J, Goebelbecker H, Gundlach J, Schirmbacher P, Dierolf UThis article describes the heterogeneous RDR landscape. Further, the article outlines the features of re3data.org, and shows how this registry helps to identify appropriate repositories for storage and search of research data.
This article argues in favor of more widespread availability of data from clinical research.
Are Scientific Data Repositories Coping with Research Data Publishing?
by Assante M, Candela L, Castelli D, Tani AThis study analyses the solutions offered by generalist scientific data repositories.
The Yale Open Data Access (YODA) Project — A Mechanism for Data Sharing
by Harlan M. Krumholz, Joanne WaldstreicherThe Yale Open Data Access (YODA) Project is one of several pioneering data-sharing models in use. It uses a “trusted intermediary” approach, in which an independent partner provides support, accountability, fairness, and transparency.
Trust, Respect, and Reciprocity: Informing Culturally Appropriate Data-Sharing Practice in Vietnam
by Merson L, Phong TV, Nhan le NT, Dung NT, Ngan T, Kinh N, Parker M, Bull SThis study used in-depth interviews and focus group discussions with 48 stakeholders in Vietnam to explore the experiences, attitudes, and expectations that inform ethical and effective approaches to sharing clinical research data.
ACCESS CV proposes a secure method of sharing sensitive patient data that balances the legitimate desire of the scientific community for data access with the responsibility to ensure high-quality analyses and protection of patients’ expectation of privacy.
Bridging the Data-Sharing Divide — Seeing the Devil in the Details, Not the Other Camp
by Lisa RosenbaumLisa Rosenbaum looks at both sides of the data sharing discussion.
Avoiding Data Dumpsters — Toward Equitable and Useful Data Sharing
by Laura Merson, Oumar Gaye, Philippe J. GuerinAlthough some researchers remain wary about sharing data, recent policies and proposals mean that data sharing, in one form or another, is inevitable.
Sharing of data from clinical trials benefits patients by enabling new discoveries, meta-analyses, and confirmation of published results.
Sharing Clinical Trial Data: A Proposal from the International Committee of Medical Journal Editors
by Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW,, Drazen JM, Fletcher J, Frizelle FA, Groves T, Haileamlak A, James A, Laine C, Peiperl L, Pinborg A, Sahni P, Wu SThe International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials.
A systematic review of motivational interviewing for weight loss among adults in primary care
by Barnes RD, Ivezaj VMotivational interviewing (MI) is a client-centred method of intervention focused on enhancing intrinsic motivation and behaviour change. This article looks at MI in adults in primary care.
Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention fol
by Sarah J Hardcastle, Adrian H Taylor, Martin P Bailey, Robert A Harley, Martin S HaggerThis is the first study to document the longer-term effects of adapted motivational interviewing, delivered in the primary care setting, on BMI, physical activity and related CVD risk factors.
This study determines how well authors comply with data sharing policies in Clinical Research Trails.
Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers
by Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers, Douglas G AltmanIain Hrynaszkiewicz and colleagues propose a minimum standard for de-identifying datasets to ensure patient privacy when sharing clinical research data.
The importance of clinical trial data sharing: toward more open science
by Joseph S. Ross, Richard Lehman, Cary P. GrossThe double-edged sword of open access to research data.
Sharing Clinical Research Data City: Washington, D.C. Publisher: National Academies Press
by Institute of Medicine, National Cancer Policy Forum, Board on Health Sciences Policy, Board on Health Care Services, Forum on Drug Discovery, Development, and Translation, Forum on Neuroscience and Nervous System Disorders, Roundtable on Translating Genomic-Based Research for Health, Steve Olson, Autumn S. Downey, RapporteursThis e-book covers benefits, barriers and models for data sharing.
The clinical research community is at an important crossroads about sharing data.
BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciences
by Peter McQuilton, Alejandra Gonzalez-Beltran, Philippe Rocca-Serra, Milo Thurston, Allyson Lister, Eamonn Maguire, Susanna-Assunta SansoneBioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world.
Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editors
by Taichman D, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong S, Haileamlak A, Gollogly L, Godlee F, Frizelle F, Florenzano F, Drazen J, Bauchner H, Baethge C, Backus JThe ICMJ gives its vision for a global research community in which sharing de-identified data becomes the norm.
Blockchains for Data Sharing in Clinical Research: Trust in a Trustless World
by John Sotos, David HouldingData sharing is now a major theme in clinical research. However, effective, ethical sharing of clinical research data requires trust: research subjects must trust investigators to preserve their privacy, investigators must trust each other to give credit where credit is due, and the integrity of the entire research enterprise must be trusted by all.
The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT) aims to improve the integrity, safety, and rigor of global clinical trials.
Clinical Trial Data Sharing
by Barbara BiererBarbara Bierer presents changes in data sharing, and gives solutions to challenges facing the feild.
The Project Data Sphere Initiative: Accelerating Cancer Research by Sharing Data
by Green AK, Reeder-Hayes KE, Corty RW, Basch E, Milowsky MI, Dusetzina SB, Bennett AV, Wood WAAccess to large, late-phase, cancer-trial data sets has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care.
This article looks at the development of software to enhance the integration between patient-care practice and medical research.
Feasibility, Process, and Outcomes of Cardiovascular Clinical Trial Data Sharing
by Hawkins C. Gay, Abigail S. Baldridge, Mark D. HuffmanData sharing is as an expanding initiative for enhancing trust in the clinical research enterprise
A new tool for the capture and conversion of clinical data is introduced as a way to encourage reuse of data and to reduce workloads in new studies.
Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users
by Joseph S Ross, Jessica D Ritchie, Emily Finn, Nihar R Desai, Richard L Lehman, Harlan M Krumholz, Cary P GrossThis article assesses the use of the BioLINCC by clinical researchers.
Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis
by Joseph S. RossThis article looks at how data sharing could change and challenge design, conduct, and reporting of systematic reviews and meta-analyses for Clinical Research, as well as it's impact on those involved in evidence synthesis.
Data sharing and the evolving role of statisticians
by Nick Manamley, Steve Mallett, Matthew R. Sydes, Sally Hollis, Alison Scrimgeour, Hans Ulrich Burger, Hans-Joerg UrbanStatisticians are ambassadors for data sharing and are central to its success; this article looks at how the role is changing with new technologies and trends for data transparency.
The article poses the question: How would data sharing work best?
Development of an open-source, flexible framework for complex inter-institutional disparate data sharing and collaboration
by Kirby C, Ambros P, Billiter D, London W, Mendonca E, Monclair T, Pearson A, Cohn S, Volchenboum SThe devolpment of a data sharing database makes it easier to harmonize and manage for data mining.
Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research.
by Bradley Malin, David Karp, Richard H. ScheuermannIn this paper, we review several aspects of the privacy-related problems associated with data sharing for clinical research from technical and policy perspectives.
Open Science and Data sharing in Clinical research: Basing Informed Decisions on the Totality of Evidence
by Krumholz HBasing Informed Decisions on the Totality of the Evidence
Application Description and Policy Model in Collaborative Environment for Sharing of Information on Epidemiological and Clinical Research Data Sets
by Elias César Araujo de Carvalho, Adelia Portero Batilana, Julie Simkins, Henrique Martins, Jatin Shah, Dimple Rajgor, Anand Shah, Scott Rockart, Ricardo PietrobonThis article describes a web appliaction for data sharing for clinical research.
Biomedical Data Sharing and Reuse: Attitudes and Practices of Clinical and Scientific Research Staff
by Lisa M. Federer, Ya-Ling Lu, Douglas J. Joubert, Judith Welsh, Barbara BrandysThis study investigates these differences in experiences with and perceptions about sharing data, as well as barriers to sharing among clinical and basic science researchers.
The Changing Structure of Industry-Sponsored Clinical Research: Pioneering Data Sharing and Transparency
by Richard E. KuntzThis article looks at the thriving interest in open science and the inevitable widespread adoption of data, and how the two can be managed.
Approaches and Costs for Sharing Clinical Research Data
by Erin E. Wilhelm, Emily Oster, Ira ShoulsonThis article looks at the complex issues behind data sharing in clinical trials.
Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy rule
by James D MillerThis article looks at the interaction in the USA between sharing data from clinical trails and the Privacy Rule adopted under the Health Insurance Portability and Accountability Act.
Sharing Privacy Protected and Statistically Sound Clinical Research Data Using Outsourced Data Storage
by Geontae Noh, Ji Young Chun, Ik Rae JeongThis article proposes a controlled secure aggregation protocol to secure both privacy and accuracy when researchers outsource their clinical research data for sharing
DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer research
by Andriy Fedorov, David Clunie, Ethan Ulrich, Christian Bauer, Andreas Wahle, Bartley Brown, Michael Onken, Jörg Riesmeier, Steve Pieper, Ron Kikinis, John Buatti, Reinhard R. BeichelArticle on the devolpment of Imaging biomarkers and the need for data sharing for this.
IMPACT Observatory: tracking the evolution of clinical trial data sharing and research integrity
by Karmela Krleža-Jerić, Mirko Gabelica, Rita Banzi, Marina Krnić- Martinić, Bibiana Pulido, Mersiha Mahmić-Kaknjo, Ludovic Reveiz, Josip Šimić , Ana Utrobičić, Irena HrgovićThe objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings
Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patients
by F. W. RockholdThe question at the center of the open-science efforts for clinical trials should not be whether data should be shared, but rather how we can usher in responsible methods for doing so.
Emerging molecular markers for the prognosis of differentiated thyroid cancer patients
by Enke Baldini, Salvatore Sorrenti, Chiara Tuccilli, Natalie Prinzi, Carmela Coccaro, Antonio Catania, Angelo Filippini, Marco Bononi, Enrico De Antoni, Massimino D'Armiento, Salvatore UlisseA review into new molecular markers potentially able to ameliorate the prognosis in thyriod cancer patients.
Sharing of clinical trial data and research integrity
by KARMELA KRLEŽA-JERIĆAn article arguing that full transparency of clinical trial data is an essential prerequisite to achieving research integrity.
Data Sharing Policy
by The Medical Research CouncilThe Medical Research Council's policy on data sharing.
Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settings
by Susan Bull, Phaik Yeong Cheah, Spencer Denny, Irene Jao, Vicki Marsh, Laura Merson, Neena Shah More, Le Nguyen Thanh Nhan, David Osrin, Decha Tangseefa, Douglas Wassenaar, Michael ParkerThis article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and middle-income settings.
Sharing Individual-Level Health Research Data: Experiences, Challenges and a Research Agenda
by Phaik Yeong Cheah, Nicholas P. J. Day, Michael Parker, Susan BullIn this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures.
Views of Ethical Best Practices in Sharing Individual-Level Data From Medical and Public Health Research
by Susan Bull, Nia Roberts, Michael ParkerThis scoping review of empirical research and conceptual literature examined stakeholders’ perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings.
Data Sharing and the Journal
by Jeffrey M. DrazenThe Journal seeks to show it's commitment to data sharing in the setting of clinical trials.
Sharing Individual Participant Data from Clinical Trials: An Opinion Survey Regarding the Establishment of a Central Repository
by Catrin Tudur Smith, Kerry Dwan, Douglas G. Altman, Mike Clarke, Richard Riley, Paula R. WilliamsonAn article looking at the major issues facing access to, and sharing of, Individual Participant Data.
Developing Ethical Practices for Public Health Research Data Sharing in South Africa
by Spencer G. Denny, Blessing Silaigwana, Douglas Wassenaar, Susan Bull, Michael ParkerAmid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa’s public research sector, but national guidance and regulation are absent.
Are clinical trial data shared sufficiently today? No
by Ben GoldacreA useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’