Study finds poor clinical trial reporting from leading academic centres

A study published in The BMJ today has found staggeringly poor levels of clinical trial reporting from 51 leading academic medical centres in the USA.

The study looked at 4,347 studies that were completed between October 2007 and September 2010, and identified trials with missing results two years after the trial completion. For the 51 institutions, the proportion of trials published ranged […]

18th February 2016|

How is transparency going at the European Medicines Agency?

A new article published in Trials reports that the European Medicines Agency’s system of releasing clinical trial documents may involve lengthy correspondence, and significant time delays.

In 2010, the European Medicines Agency (EMA) introduced a new policy to make detailed clinical trial information available on request. Between 2011 and 2015, the authors of the Trial study made 12 separate requests […]

16th February 2016|

MEPs call for faster implementation of clinical trial regulation

The Group of the Progressive Alliance of Socialists and Democrats (the S&D Group) is today calling on the European Commission to speed up implementation of the new European Clinical Trial Regulation. The S&D Group is the second largest political group in the European Parliament with 190 members from all 28 EU member states.

The call follows the recent […]

2nd February 2016|

Wellcome Trust appoints new independent review panel for clinical data sharing website

The Wellcome Trust has appointed a new independent review panel to assess applications from researchers for access to clinical trial data through the website

The website was set up by GlaxoSmithKline (GSK) in May 2013 to allow researchers to request trial data to carry out further research. Since then 12 more pharmaceutical companies have also committed to […]

26th January 2016|

British Pharmacological Society calls for transparency early in clinical research

Today, the British Pharmacological Society (BPS) has released a statement calling for greater trial transparency in the testing of new medicines. Following the recent phase 1 clinical trial catastrophe in France, the BPS recommends “release of the study design and protocol, the full Investigation Medicinal Product Dossier (IMPD) and the batch release data for such studies, […]

22nd January 2016|

International Committee of Medical Journal Editors proposes individual patient data sharing

The International Committee of Medical Journal Editors (ICMJE) is proposing that authors must share the anonymised individual patient data (IPD) underlying clinical trial results published in its member journals.

On January 20th 2016 the ICMJE published an editorial in 14 major medical journals sharing their proposal, and are inviting feedback until April 18th 2016.

The ICMJE also […]

21st January 2016|

Clinical trial participants speak out over missing trial results

In the past week, The New York Times and The Atlantic have both published incredibly moving pieces written by clinical trial participants. Each patient has their own journey and experience, but both have something in common; a sense of outrage and betrayal over the systematic failing to register trials and report results.

AllTrials is a campaign to get all clinical […]

19th January 2016|

Comment from Ben Goldacre on the phase 1 clinical trial disaster in France

It is being reported that one person has been left in a coma and five others are in a critical condition in hospital after taking part in a phase 1 drug trial in France.

Phase 1 clinical trials test new drugs in healthy volunteers to evaluate their safety. In 2006 in the UK six people were […]

15th January 2016|

Why AllTrials matters to vets

AllTrials is a campaign to get all clinical trials registered and their results reported. Even though AllTrials is focused on clinical trials in human medicine, the success of the campaign is important to vets too, who do not even have a clinical trial registry.

An international group of interested organisations and individuals within the veterinary profession are […]

23rd December 2015|

Enacting Pharmaceutical Transparency – Who, What, How, When & Why

In this guest piece, Matthew Herder shares a template letter that physicians, researchers, civil society groups, investigative journalists and others can use to gain access to unpublished pharmaceutical safety and effectiveness data.
This is a call to action—a call that physicians, biomedical researchers, civil society, journalists and others have long made concerning the need to improve […]

21st December 2015|