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 • 0 comments

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 • 0 comments

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

21st February 2018 • 0 comments

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

21st February 2018 • 0 comments

Sharing of research data

by 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.

21st February 2018 • 0 comments

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

21st February 2018 • 0 comments

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

21st February 2018 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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

20th February 2018 • 0 comments

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

20th February 2018 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments

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 • 0 comments