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.
a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.
Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits
In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically
This 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
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 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.
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
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.
This article looks at the benefits of data sharing, and argues for increasing the accessibility of data
This article details the procedures and requirements for researchers in sharing data from clinical trials.
This article proposes some key characteristics needed in a clinical data warehouses for biomedical research
This article asks the question: how do we achieve fair trade in the sharing of clinical data?
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.
This article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.
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.
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.
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
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.
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.
Heather A Piwowar proposes that AHCs can and should lead the transition towards a culture of biomedical data sharing.
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.
This 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.
This article looks at the ethical problems involved in data sharing within the Genome-Wide Association Studies in Developing Countries
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
This article argues that expanded data sharing must be pursued thoughtfully.
This paper discusses important developments in data-sharing policy and highlights factors in health research that may affect policy implementation
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.
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.
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.
This article aims to address inadequate reporting in randomised controlled trials.
After a global push, cancer clinical trial data is to be shared.
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
Medical journals should insist on the release of all raw data and a written independent clinical audit.
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
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
Peter 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
This paper describes this policy as well as the limited access data sets currently available from NHLBI.
This 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.
The EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.
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.
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.
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.
The article describes several approaches that can be used in meeting the challenges posed by the sharing of confidential data.
This guide looks at whether deidentification is sufficient in data sharing.
This article looks at rules and regulations for data shring.
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.
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.
This article looks at the problems caused by inaccessible data to journal reporting, finance and funding; it then looks at possible solutions.
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.
Elliot 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.
Elizabeth 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.
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.
The University of Carolina offers a free eLearning course about data management and sharing.
The two-day symposium enabled an international group to meet and share experiences of the TwiCs design and to discuss plans for future research.
The University of Oxford's tips for data management planning.
The ACDM represents professionals working in the management of clinical data
The Bill and Melinda Gates foundation answers questions about their open access policy.
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.
This study looks at the commitments made by companies to transparency of trials.
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.
This article argues in favor of more widespread availability of data from clinical research.
This study analyses the solutions offered by generalist scientific data repositories.
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.
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.
Lisa Rosenbaum looks at both sides of the data sharing discussion.
Although 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.
The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials.
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.
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 double-edged sword of open access to research data.
This 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 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.
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.
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.
This article looks at the development of software to enhance the integration between patient-care practice and medical research.
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.
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.
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.
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.
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.
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.
A review into new molecular markers potentially able to ameliorate the prognosis in thyriod cancer patients.
An article arguing that full transparency of clinical trial data is an essential prerequisite to achieving research integrity.
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.
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.
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.
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.
Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenyaby Irene Jao, Francis Kombe, Salim Mwalukore, Susan Bull, Michael Parker, Dorcas Kamuya, Sassy Molyneux, Vicki Marsh
Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement
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.
A Qualitative Study of Experiences With and Attitudes Toward Data Sharing Among Research Staff and Community Representatives in Thailand.
A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’
Do you have research ideas for using big data to fill gender data gaps? Announcing the Big Data for Gender Challenge! Research proposals are due on July 7, 2017
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
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.