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Drug firms take legal steps to prevent European regulator releasing data

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.

Preparing individual patient data from clinical trials for sharing: The GlaxoSmithKline approach

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. 

Towards agreement on best practice for publishing raw clinical trial data

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

Project data sphere to make cancer clinical trial data publicly available.

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

Sharing of research data

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.

Full access to trial data holds many benefits and a few pitfalls, conference hears

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

Time to mandate data release and independent audits for all clinical trials

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

Strengthening and opening up health research by sharing our raw data

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

Why we need easy access to all data from all clinical trials and how to accomplish it

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

We need access to all data from all clinical trials.

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

The new BMJ policy on sharing data from drug and device trials

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

Limited access data sets from studies funded by the National Heart, Lung, and Blood Institute

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

Redefining genomic privacy: trust and empowerment

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

Routes for breaching and protecting genetic privacy

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.

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

The EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.

Respectful re-use

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.

Data sharing will pay dividends

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.

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

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.

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.

Part III: Meeting the Challenge When Data Sharing Is Required

The article describes several approaches that can be used in meeting the challenges posed by the sharing of confidential data.