Transparency on trial

US plans to require trial consent publication

TRIAL TRANSPARENCY

US plans to require trial consent publication

By Fiona BARRY

The US government may require companies running clinical trials to post their informed consent forms publicly, under rules proposed by the Department of Health and Human Services (HHS).

Mr Justice Jay ruled phrasing on the HRA website was unclear

TRIAL TRANSPARENCY

CRO vs HRA trial transparency case ends in a win for industry

By Fiona BARRY

A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...

European Parliament in Strasbourg, France

EMA tells us it looks forward to continuing close relationship with DG SANCO

Juncked: Plan to move EMA from DG Health to DG Enterprise is abandoned

By Gareth Macdonald

DG Health will keep responsibility for the EMA according to European Commission President-elect Jean-Claude Juncker, who confirmed plans to hand the agency to DG Enterprise have been abandoned.

EU MEPs plan to make drugmakers upload trial data to public database

breaking news

EU MEPs plan to make drugmakers make trial data public

By Gareth Macdonald

Drugmakers and academics will have to upload the results of trials run in Europe to a public database under a provisional deal agreed in the European Parliament earlier today.

GSK, European Parliament Begin Push for Clinical Trial Transparency

GSK, European Parliament Begin Push for Clinical Trial Transparency

By Zachary Brennan

A storm is brewing over the release of clinical trial data as GlaxoSmithKline on Tuesday took a step away from UK and US industry groups and said it intends to publish clinical study reports for all approved medicines dating back to when the company was...

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