Participant-level data and the new frontier in trial transparencyby Deborah A. Zarin
We 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-changingby Beate Wieseler, Natalie McGauran, Michaela F Kerekes, Thomas Kaiser
a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.
Sharing research data to improve public healthby Walport, M, Brest, P.
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 trialsby Andrew Vickers
In 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 healthby Willem G van Panhuis, Proma Paul, Claudia Emerson, John Grefenstette, Richard Wilder, Abraham J Herbst, David Heymann, Donald S Burke
This study looks at the challneges of data sharing globally.
Secure use of individual patient data from clinical trialsby Patrick Vallance, Iain Chalmers
Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons
Prepublication data sharingby Toronto International Data Release Workshop Authors
Rapid 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 perspectivesby Viroj Tangcharoensathien, Jirawan Boonperm, Pongpisut Jongudomsuk
Sharing 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 databy Strech D, Littmann J
Comparing 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 databy John A. Spertus
John 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 livesby Josh Sommer
This 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 industryby So D, Joly Y, Knoppers BM
This 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 databy 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 techniquesby 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 researchby Soo-Yong Shin, Woo Sung Kim, Jae-Ho Lee
This 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 southby Osman Sankoh, Carel IJsselmuiden
This article asks the question: how do we achieve fair trade in the sharing of clinical data?
The International Stroke Trial databaseby Peter AG Sandercock, Maciej Niewada, Anna Członkowska, the International Stroke Trial Collaborative Group
We 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 downby Joseph S. Ross, Harlan M. Krumholz
This 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 researchby Ross JS, Gross CP, Krumholz HM
Policies 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.
Clinical trial data as a public goodby Marc A. Rodwin, John D. Abramson
Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.
Data sharing in medical research: an empirical investigationby Reidpath DD, Allotey PA.
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 surveyby Vinay Rathi, Kristina Dzara, Cary P Gross, Iain Hrynaszkiewicz, Steven Joffe, Harlan M Krumholz, Kelly M Strait, Joseph S Ross
This 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 Consultationby Manju Rani, Hendrik Bekedam, Brian S. Buckley
WHO organised an expert consultation on research in the Western Pacific
A mechanism for controlled access to GWAS data: experience of the GAIN Data Access Committeeby 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 LL
This 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 vaultby Tania Rabesandratana
EMA 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 centersby Heather A Piwowar, Michael J Becich, Howard Bilofsky, Rebecca S Crowley
Heather A Piwowar proposes that AHCs can and should lead the transition towards a culture of biomedical data sharing.
Withholding access to research data - Authors' replyby Elizabeth Pisani, James Whitworth, Basia Zaba, Carla AbouZahr
The 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 databy Elizabeth Pisani, James Whitworth, Basia Zaba, Carla Abou-Zahr
This argues for all the positives of data sharing
Sharing health data: good intentions are not enoughby Pisani E, AbouZahr C
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.
Data sharing: not as simple as it seemsby Pearce N, Smith AH
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 countriesby Michael Parker, Susan J. Bull, Jantina de Vries, Tsiri Agbenyega, Ogobara K. Doumbo, Dominic P. Kwiatkowski
This 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 Medicineby Perry Nisen, Frank Rockhold
GSK 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 Barnes
This 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 Buckley
This 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 Lopez
This 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 emergenciesby Pinky Langat, Dmitri Pisartchik, Diego Silva, Carrie Bernard, Kolby Olsen, Maxwell Smith, Sachin Sahni, Ross Upshur
This 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 databy Zosia Kmietowicz
A 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 approachby 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 databy Iain Hrynaszkiewicz, Douglas G Altman
This 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 databy Donald J Harris
Geoffrey 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 trialsby Haines IE, Gabor Miklos GL
Medical 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 databy Peter C. Gøtzsche
Peter 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 itby Gøtzsche PC
Gøtzsche 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 Gøtzsche
Peter Gøtzsche argues why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available
The new BMJ policy on sharing data from drug and device trialsby Fiona Godlee, Trish Groves
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 Instituteby Geller NL, Sorlie P, Coady S, Fleg J, Friedman L
This paper describes this policy as well as the limited access data sets currently available from NHLBI.
Redefining genomic privacy: trust and empowermentby Yaniv Erlich, James B. Williams, David Glazer, Kenneth Yocum, Nita Farahany, Maynard Olson, Arvind Narayanan, Lincoln D. Stein, Jan A. Witkowski, Robert C. Kain
This article suggests the use of trust-enabling techniques to create a solution in which researchers and participants both win with data sharing.
Routes for breaching and protecting genetic privacyby Yaniv Erlich, Arvind Narayanan
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 developersby Hans-Georg Eichler, Frank Pétavy, Francesco Pignatti, Guido Rasi
The EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.
Respectful re-useby Nature Genetics
The 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 dividendsby Nature
As 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 Oncologyby Edward S. Dove, Bartha M. Knoppers, Ma'n H. Zawati
This 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 Doshi
Peter 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 Requiredby de Wolf, V. A, Sieber, J. E, Steel, P. M, Zarate, A. O
The 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 Issuesby Virginia A. de Wolf, Joan E. Sieber, Philip M. Steel, Alvan O. Zarate
This 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. Zarate
This article looks at rules and regulations for data sharing.
Sharing individual level data from observational studies and clinical trials: a perspective from NHLBIby Sean A Coady, Elizabeth Wagner
The 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 lawby Cleary, M, Jackson, D, Walter, G
This article argues that ownership of research data is a complex issue and warrents cafeful examination.
A review of the barriers to sharing in biobankingby Colledge F, Elger B, Howard HC
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 researchby Chan, A.-W, Song, F, Vickers, A, Jefferson, T, Dickersin, K, Gotzsche, P. C, Krumholz, H, Ghersi,D, van der Worp, H. B
This 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 parentsby 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.
Withholding access to research databy Brewer DD, Potterat, J. J, Muth, S. Q
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 cliniciansby Elliott Antman
Elliot Antman explore issues surrounding data sharing in scientific research
Data sharing for pharmacokinetic studiesby Anderson, B. J, Merry, A. F
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 Sharingby Elizabeth Warren
Elizabeth Warren addresses the policy, privacy, and practical issues affecting data sharing in clinical trails.
A Global, Neutral Platform for Sharing Trial Databy Bierer B, Li R, Barnes M, Sim I
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 Trialsby Charlotte J. Haug
This 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 contentsby Cancer research UK
Cancer 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 Sharingby University of North Carolina
The University of Carolina offers a free eLearning course about data management and sharing.
The ethics of 'Trials within Cohorts' (TWiCs) 2nd international symposiumby 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 M
The 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 planningby Research Data Oxford
The 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 Foundationby Gates Foundation
The Bill and Melinda Gates foundation answers questions about their open access policy.
Data sharing statements for clinical trialsby 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 J
The 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 arthritisby Kirkham J, Clarke M, Williamson P
This 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.
Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (Version 1) GOOD PRACTICE PRINCIPLES FOR SHARING INDIVIDUAL PARTICIPANT DATA FROM PUBLICLY FUNDEDby Tudur Smith C
Thid guide offers good practice principles for sharing data from clinical trails
Guidelines for MRC research and management of data.
Pharmaceutical companies' policies on access to trial data, results, and methods: audit studyby Goldacre B, Lane S, Mahtani K, Heneghan C, Onakpoya I, Bushfield I, Smeeth L
This study looks at the commitments made by companies to transparency of trials.
Making research data repositories visible: The re3data.org registryby Pampel H, Vierkant P, Scholze F, Bertelmann R, Kindling M, Klump J, Goebelbecker H, Gundlach J, Schirmbacher P, Dierolf U
This 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.
Raw data from clinical trials: Within reach?by Doshi P, Goodman S,, Ioannidis J
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 A
This study analyses the solutions offered by generalist scientific data repositories.
The Yale Open Data Access (YODA) Project — A Mechanism for Data Sharingby Harlan M. Krumholz, Joanne Waldstreicher
The 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 Vietnamby Merson L, Phong TV, Nhan le NT, Dung NT, Ngan T, Kinh N, Parker M, Bull S
This 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 Campby Lisa Rosenbaum
Lisa Rosenbaum looks at both sides of the data sharing discussion.
Avoiding Data Dumpsters — Toward Equitable and Useful Data Sharingby Laura Merson, Oumar Gaye, Philippe J. Guerin
Although some researchers remain wary about sharing data, recent policies and proposals mean that data sharing, in one form or another, is inevitable.
Incentives for Clinical Trialists to Share Databy Bernard Lo, David L. DeMets
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 Editorsby 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 S
The 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 careby Barnes RD, Ivezaj V
Motivational 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 folby Sarah J Hardcastle, Adrian H Taylor, Martin P Bailey, Robert A Harley, Martin S Hagger
This 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.
Empirical study of data sharing by authors publishing in PLoS journalsby Savage C, Vickers A
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 reviewersby Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers, Douglas G Altman
Iain 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 scienceby Joseph S. Ross, Richard Lehman, Cary P. Gross
The double-edged sword of open access to research data.
Sharing Clinical Research Data City: Washington, D.C. Publisher: National Academies Pressby 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, Rapporteurs
This e-book covers benefits, barriers and models for data sharing.
Data Sharing at a Crossroadsby Frank Rockhold, Perry Nisen, Andrew Freeman
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 sciencesby Peter McQuilton, Alejandra Gonzalez-Beltran, Philippe Rocca-Serra, Milo Thurston, Allyson Lister, Eamonn Maguire, Susanna-Assunta Sansone
BioSharing 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 Editorsby 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 J
The 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 Worldby John Sotos, David Houlding
Data 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.
Data Sharing; Transparency Initiative - The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospitalby MCRT
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 Sharingby Barbara Bierer
Barbara Bierer presents changes in data sharing, and gives solutions to challenges facing the feild.
The Project Data Sphere Initiative: Accelerating Cancer Research by Sharing Databy Green AK, Reeder-Hayes KE, Corty RW, Basch E, Milowsky MI, Dusetzina SB, Bennett AV, Wood WA
Access 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.
A SOA-Based Platform to Support Clinical Data Sharingby R. Gazzarata, B. Giannini, M. Giacomini
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 Sharingby Hawkins C. Gay, Abigail S. Baldridge, Mark D. Huffman
Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise
Introduction to Research Electronic Data Capture (REDCap) and REDCap2SDTM, a Conversion Tool to Facilitate Clinical Research Data Sharingby Yamamoto K
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 usersby Joseph S Ross, Jessica D Ritchie, Emily Finn, Nihar R Desai, Richard L Lehman, Harlan M Krumholz, Cary P Gross
This 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 synthesisby Joseph S. Ross
This 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 statisticiansby Nick Manamley, Steve Mallett, Matthew R. Sydes, Sally Hollis, Alison Scrimgeour, Hans Ulrich Burger, Hans-Joerg Urban
Statisticians 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.
Data Sharingby Dan L. Longo, Jeffrey M. Drazen
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 collaborationby Kirby C, Ambros P, Billiter D, London W, Mendonca E, Monclair T, Pearson A, Cohn S, Volchenboum S
The 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. Scheuermann
In 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 Evidenceby Krumholz H
Basing 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 Setsby Elias César Araujo de Carvalho, Adelia Portero Batilana, Julie Simkins, Henrique Martins, Jatin Shah, Dimple Rajgor, Anand Shah, Scott Rockart, Ricardo Pietrobon
This article describes a web appliaction for data sharing for clinical research.
Biomedical Data Sharing and Reuse: Attitudes and Practices of Clinical and Scientific Research Staffby Lisa M. Federer, Ya-Ling Lu, Douglas J. Joubert, Judith Welsh, Barbara Brandys
This 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 Transparencyby Richard E. Kuntz
This 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 Databy Erin E. Wilhelm, Emily Oster, Ira Shoulson
This 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 ruleby James D Miller
This 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 Storageby Geontae Noh, Ji Young Chun, Ik Rae Jeong
This 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 researchby Andriy Fedorov, David Clunie, Ethan Ulrich, Christian Bauer, Andreas Wahle, Bartley Brown, Michael Onken, Jörg Riesmeier, Steve Pieper, Ron Kikinis, John Buatti, Reinhard R. Beichel
Article 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 integrityby Karmela Krleža-Jerić, Mirko Gabelica, Rita Banzi, Marina Krnić- Martinić, Bibiana Pulido, Mersiha Mahmić-Kaknjo, Ludovic Reveiz, Josip Šimić , Ana Utrobičić, Irena Hrgović
The 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 patientsby F. W. Rockhold
The 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 patientsby Enke Baldini, Salvatore Sorrenti, Chiara Tuccilli, Natalie Prinzi, Carmela Coccaro, Antonio Catania, Angelo Filippini, Marco Bononi, Enrico De Antoni, Massimino D'Armiento, Salvatore Ulisse
A review into new molecular markers potentially able to ameliorate the prognosis in thyriod cancer patients.
Sharing of clinical trial data and research integrityby KARMELA KRLEŽA-JERIĆ
An article arguing that full transparency of clinical trial data is an essential prerequisite to achieving research integrity.
Data Sharing Policyby The Medical Research Council
The Medical Research Council's policy on data sharing.
Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settingsby 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 Parker
This 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 Agendaby Phaik Yeong Cheah, Nicholas P. J. Day, Michael Parker, Susan Bull
In 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 Researchby Susan Bull, Nia Roberts, Michael Parker
This 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 Journalby Jeffrey M. Drazen
The 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 Repositoryby Catrin Tudur Smith, Kerry Dwan, Douglas G. Altman, Mike Clarke, Richard Riley, Paula R. Williamson
An 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 Africaby Spencer G. Denny, Blessing Silaigwana, Douglas Wassenaar, Susan Bull, Michael Parker
Amid 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? Noby Ben Goldacre
A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’
Powerpoint slides representing a comprehensive overview of some issues surrounding data management, including an overview of data management, the issue of coding, and regulations and guidelines. NEW ADDITIONS AUGUST 2013: Code of Federal Regulations part 11 - Guidelines on how to implement
Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.by Harry van Loen
Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?by The Editorial Team
This publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.
This article explains the process of data management operations within clinical trials from start to finish.
An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.
Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.