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.

22nd February 2018 • 0 comments

Access to regulatory data from the European Medicines Agency: the times they are a-changing

by 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.

22nd February 2018 • 0 comments

Jimmy Whitworth calls for a more sustainable and palatable pathway be will to build consensus and to create a broad coalition.

22nd February 2018 • 0 comments

Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits

22nd February 2018 • 0 comments

In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically

22nd February 2018 • 0 comments

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 Burke

This study looks at the challneges of data sharing globally. 

22nd February 2018 • 0 comments

Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons

22nd February 2018 • 0 comments

Prepublication data sharing

by 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.

22nd February 2018 • 0 comments

Sharing health data: developing country perspectives

by 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

22nd February 2018 • 0 comments

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.

22nd February 2018 • 0 comments

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 

22nd February 2018 • 0 comments

This article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.

22nd February 2018 • 0 comments

This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.

22nd February 2018 • 0 comments

This article looks at the benefits of data sharing, and argues for increasing the accessibility of data

22nd February 2018 • 0 comments

This article details the procedures and requirements for researchers in sharing data from clinical trials. 

22nd February 2018 • 0 comments

This article proposes some key characteristics needed in a clinical data warehouses for biomedical research

22nd February 2018 • comment

This article asks the question: how do we achieve fair trade in the sharing of clinical data?

22nd February 2018 • comment

The International Stroke Trial database

by 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.

22nd February 2018 • comment

This article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.

22nd February 2018 • comment

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.

22nd February 2018 • comment

Clinical trial data as a public good

by Marc A. Rodwin, John D. Abramson

Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.

22nd February 2018 • comment

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.

22nd February 2018 • comment

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 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.

22nd February 2018 • comment

WHO organised an expert consultation on research in the Western Pacific

22nd February 2018 • comment

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 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.

22nd February 2018 • comment

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.

22nd February 2018 • comment

Towards a data sharing culture: recommendations for leadership from academic health centers

by 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.

22nd February 2018 • comment

Withholding access to research data - Authors' reply

by 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.

22nd February 2018 • comment

Time for fair trade in research data

by Elizabeth Pisani, James Whitworth, Basia Zaba, Carla Abou-Zahr

  This argues for all the positives of data sharing

21st February 2018 • comment

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.

21st February 2018 • comment

This article argues that it is inappropriate to prescribe exactly when or how researchers should preserve and share data.

21st February 2018 • comment

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. Kwiatkowski

This article looks at the ethical problems involved in data sharing within the Genome-Wide Association Studies in Developing Countries

21st February 2018 • comment

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

21st February 2018 • comment

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.  

21st February 2018 • comment

This paper discusses important developments in data-sharing policy and highlights factors in health research that may affect policy implementation

21st February 2018 • comment

This article argues that WHO need to take leadership of the data sharing debate

21st February 2018 • comment

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 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. 

21st February 2018 • comment

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.

21st February 2018 • comment

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. 

21st February 2018 • comment

This article aims to address inadequate reporting in randomised controlled trials.

21st February 2018 • comment

After a global push, cancer clinical trial data is to be shared. 

21st February 2018 • comment

The BMJ Group and the Association of the British Pharmaceutical Industry conference discusses the dangers and promises of trial data 

21st February 2018 • comment

Medical journals should insist on the release of all raw data and a written independent clinical audit.

21st February 2018 • comment

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

20th February 2018 • comment

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

20th February 2018 • comment

Peter Gøtzsche argues why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available

20th February 2018 • comment

The BMj's new policy is a necessary first step towards the full sharing of all anonymised trial data

20th February 2018 • comment

This paper describes this policy as well as the limited access data sets currently available from NHLBI.

20th February 2018 • comment

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. Kain

This article suggests the use of trust-enabling techniques to create a solution in which researchers and participants both win with data sharing.

20th February 2018 • comment

Routes for breaching and protecting genetic privacy

by 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.

20th February 2018 • comment

Access to patient-level trial data--a boon to drug developers

by 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.

20th February 2018 • comment

Respectful re-use

by 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.

20th February 2018 • comment

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.

20th February 2018 • comment

Towards an Ethics Safe Harbour for Global Breast Cancer Research. Current Oncology

by 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

20th February 2018 • comment

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.

14th February 2018 • comment

Part III: Meeting the Challenge When Data Sharing Is Required

by 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.

14th February 2018 • comment

Part II: HIPAA and Disclosure Risk Issues

by Virginia A. de Wolf, Joan E. Sieber, Philip M. Steel, Alvan O. Zarate

This guide looks at whether deidentification is sufficient in data sharing. 

14th February 2018 • comment

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. 

14th February 2018 • comment

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.

13th February 2018 • comment

This article argues that ownership of research data is a complex issue and warrents cafeful examination. 

13th February 2018 • comment

A review of the barriers to sharing in biobanking

by 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.

13th February 2018 • comment

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. B

This article looks at the problems caused by inaccessible data to journal reporting, finance and funding; it then looks at possible solutions. 

13th February 2018 • comment

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.

13th February 2018 • comment

Withholding access to research data

by 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.

13th February 2018 • comment

Elliot Antman explore issues surrounding data sharing in scientific research

13th February 2018 • comment

Data sharing for pharmacokinetic studies

by 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. 

13th February 2018 • comment

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 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.

8th February 2018 • comment

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.

6th February 2018 • comment

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. Williamson

An article looking at the major issues facing access to, and sharing of, Individual Participant Data.

6th February 2018 • comment

Developing Ethical Practices for Public Health Research Data Sharing in South Africa

by 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.

6th February 2018 • comment

A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’

5th February 2018 • comment

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

24th May 2017 • comment

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:

  1. Expressing how many people are contributing data at any point in the graph, including the  pattern of censoring
  2. Expressing that the uncertainty of the estimate increases over time
  SuggestionWe have some initial suggestions on how to improve Kaplan-Meier plots, but we need your help to know which would be the most useful and most acceptable to a wide audience.

23rd May 2017 • comment

Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.

23rd December 2016 • comment

AREF is calling for researcher applications to participate in its 2nd Essential Grant Writing Skills Workshop, to be held in Dakar, Senegal, in May 2017.

19th December 2016 • comment

Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.

24th October 2016 • comment

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.

28th June 2016 • comment

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.

11th February 2016 • comment

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.

11th January 2016 • comment

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.

23rd December 2015 • comment

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.

22nd December 2015 • comment

Twitter plays role in information distribution during emergencies, and it is widely used by public health organisations during public health crises.

11th December 2015 • comment

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.

27th November 2015 • comment

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.

26th November 2015 • comment

East African Leaders Join Together to Develop Country-Specific Plans for Point-of-Care Testing.

25th November 2015 • comment

Two great articles from the African Society for Laboratory Medicine looking at the increasing risk posed by antimicrobial resistance.

20th November 2015 • comment

Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.

19th October 2015 • comment

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.

2nd October 2015 • comment

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.

22nd July 2015 • comment

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.

21st July 2015 • comment

Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh

16th June 2015 • comment

In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.

15th June 2015 • comment

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.

11th June 2015 • comment

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.

11th June 2015 • comment

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.

5th June 2015 • comment

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.

3rd June 2015 • comment

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'.

12th May 2015 • comment

This is a nice guidance document on principles in electronic data capture from Industry perspective (FDA)

18th March 2013 • comment

SOP's

by James Smedley, Yves Claeys
1st March 2013 • comment

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.

20th February 2013 • comment

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.

25th January 2013 • comment