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Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopia

We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.

Workshop Report: Collaborations and Partnerships for the conduct of Health Research in Nigeria

The Nigerian Global Health Trial Conference 2018 took place on the 30th and 31st of January 2018 the Sickle Cell Centre, Idi-Araba, Lagos. The full report here is shared to allow others to experience and learn from the event.

Participant-level data and the new frontier in trial transparency

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-changing

a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.

Data sharing: reaching consensus.

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

Sharing research data to improve public health

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

Whose data set is it anyway? Sharing raw data from randomized trials

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 health

This study looks at the challneges of data sharing globally. 

Secure use of individual patient data from clinical trials

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

Prepublication data sharing

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 perspectives

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 data

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 data

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 lives

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 industry

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 data

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

Introduction: data sharing and disclosure limitation techniques

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

Characteristics desired in clinical data warehouse for biomedical research

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 south

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