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AllTrials puts FDA under pressure with Trials Tracker

Image: AllTrials - Ben Goldacre and Siles Lane

A year to the day that the FDA unveiled its Final Rule, which sees organisation given 13 months from clinical trial completion to publish summary results and adverse events, AllTrials announced a website that would track compliance.

AllTrials revealed a website that automatically pulls data from clinicaltrials.gov and effectively names-and-shames those companies or organisations that have not posted results for their trials.

Judge rules pharma has ‘ethical' transparency obligation – reaction

Scales of justice
Flickr/Mike Cogh

Both sides of a bitterly contested legal battle over a major part of the industry's transparency drive have reacted to the judge's verdict.

A judge ruled that the Health Research Authority is acting within the law in pushing through plans for companies to register clinical trials in active recruitment in the UK.

Judge backs HRA in transparency legal case

Gavel
The HRA's plans for greater pharma transparency are being challenged in the courts

A judge has ruled that there are likely to be no legal grounds to block the Health Research Authority’s plans for companies to register clinical trials, after the move was challenged in the courts.

The ruling means that the Health Research Authority (HRA) can push on with its requirements for all sponsors of clinical trials in active recruitment in the UK in order to gain ethical approval – a central plank of the industry’s transparency agenda.

Ruling in transparency case ‘due within days’

Sense About Science
Sense About Science outside court in Manchester for the judicial review (Twitter/Bede Constantinides)

A judge is set to rule on a controversial legal challenge to the requirement for the pharma industry to register clinical trials in active recruitment in the UK.

Clinical trials firm Richmond Pharmacology was granted permission to seek the judicial review in May.

It's time the industry spoke out about legal challenge to clinical trial transparency

Published on 16/07/15 at 12:06pm
R&D
Credit: Bristol-Myers Squibb

The judicial review brought by Richmond Pharmacology against the Health Research Authority – erroneous, a waste of public money and if left unchallenged by the biopharmaceutical industry, hugely damaging to it.

Dear Editor,

Industry awaits outcome of transparency legal challenge

R&D
Credit: Bristol-Myers Squibb

A judge will today hear arguments from the Health Research Authority and campaigners who are contesting a judicial review of plans for industry transparency.

Richmond Pharmacology, an early-stage clinical research company, will argue at the administrative court in Manchester that the plans by the Health Research Authority (HRA), the ethical approval body for trials, to require the pharma industry to register all clinical trials are unlawful.

World Health Organisation calls for full trial transparency

WHO image
World Health Organization headquarters in Geneva

The World Health Organization has thrown its weight behind clinical trial transparency in a new statement on its position.

WHO says that researchers have an ‘ethical imperative’ to report results from clinical trials and that results should be made publicly available within 12 months of the study’s end – although it notes that it should be possible for reporting to occur in shorter timeframes in ‘most instances’.

Government spending on Tamfilu is justified

Tamiflu image

The most thorough analysis of Roche’s Tamiflu to date suggests that the controversial treatment can shorten the duration of flu symptoms by about a day – but concerns over side effects remain.

Previously the government’s decision to stockpile £424 million of the drug had been called a waste of money, after research published in the BMJ suggested there was no evidence for its effectiveness.

EMA launches consultation on clinical trials

EMA image
The EMA is asking companies and stakeholders if the proposal meets requirements

The European Medicines Agency has invited pharma to comment on its proposals to ramp up transparency in the industry and force companies to publish the results of clinical trials.

The EU Clinical Trial Regulation was voted into law in April 2014 and states that information from clinical trials should generally not be considered commercially confidential.

Pharma and transparency: actions speak louder than words

Published on 13/10/14 at 07:56am
ABPI image
A payment disclosure system will be accessed through the ABPI website, with users being able to search the database

As an industry we continue to deliver innovative, life changing medicines and rewrite the story of many diseases, yet our social contract remains the subject of debate, commentary and challenge.

The conventional focus on prescriber relationships, though still important, has been increasingly superseded by the outcomes of health technology assessment (HTA) decision-making processes, guideline content and formulary inclusion. Fewer individuals are having a far greater impact on the use of a medicine.

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