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.
Jimmy 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
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.
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 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.
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.
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.
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.
A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’
Invitation to complete quick survey to improve Kaplan-Meier plots (KMunicate) ProblemThe standard way to present time-to-event data, such as survival, is with Kaplan-Meier plots. These are formatted by journals and reported in a number of ways, but we find they commonly lack some key information. The key problems are:
- Expressing how many people are contributing data at any point in the graph, including the pattern of censoring
- Expressing that the uncertainty of the estimate increases over time
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate that there is scope for an individual participant-level database, to allow for standardised analyses.
Quality of care assessment is one of the ways of evaluating what the health system is providing, however, such monitoring depends on an ability to measure quality with the availability of high quality data.
Deployed in April 2015, we have established proof-of-principle for real-time genomic surveillance by generating over 40 genome sequences in as little as 48 hours from obtaining a patient sample and feeding the information back to the Ebola central coordination team.
This talk covers several research projects we are undertaking to assess the Electronic Health Record landscape in Kenya and current large-scale projects to roll out Open Source EHR systems to public hospitals.
Building on the concept of rapid learning health systems, Dr. Peek’s seminar focuses on the use of health information technology to address epidemiological and public health questions and to accelerate the translation of research findings to clinical practice.
Twitter plays role in information distribution during emergencies, and it is widely used by public health organisations during public health crises.
eSeminar: Research papers that make a difference: discussing research waste, reproducibility and impactby Iveta Simera, the EQUATOR Network
Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.
Video of Professor Peter Horby, the University of Oxford, on how he and his team set up clinical trials in the heart of the Ebola outbreak.
East African Leaders Join Together to Develop Country-Specific Plans for Point-of-Care Testing.
Two great articles from the African Society for Laboratory Medicine looking at the increasing risk posed by antimicrobial resistance.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Whilst our understanding of drug resistant Plasmodium falciparum is quite well understood, the extent and nature of resistance in Plasmodium vivax parasites is for the most part unknown.
Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh
In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.
In this video of a seminar delivered at the University of Oxford in June 2014, Professor Nicholas White talks about the challenge of antimalarial resistance.
Anders Björkman is Professor of Infectious Disease at the Karolinska Institute. In this video, Anders talks about how the efficacy of antimalarials is a major obstacle in the path towards full malaria elimination.
Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.
In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.
Professor Mike English explains how KEMRI-Wellcome are ''working with government to generate patient level data from a network of Kenyan hospitals as a platform for research'.
This is a nice guidance document on principles in electronic data capture from Industry perspective (FDA)
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.