Monthly Archives: July 2014

New FDA draft consent form guidance omits patient data sharing

The FDA is drafting new guidelines on writing consent forms for those who run clinical trials. The consent forms need to ensure patients have the information they need to make an informed decision about participating in a trial. This includes details about the clinical trial, the risks and benefits of participating in the trial, how […]

31st July 2014|

Results from a closed clinical trials register are either scattered or missing

A BMJ Open study has found that results which were posted on a now closed industry-sponsored clinical trials register – – are either scattered across various other registers or no longer publicly available. was created in 2005 by the US trade group, the Pharmaceutical Research and Manufacturers Association for pharmaceutical companies to post […]

17th July 2014|

AllTrials strongly supports HRA proposals on registration and reporting

The UK’s Health Research Authority (HRA) has made some strong proposals to encourage researchers to register clinical trials and report research results. We should all support these proposals before the end of the consultation period on 28th July 2014.

The HRA has already made registration of clinical trials a condition of ethical approval to run a […]

17th July 2014|

Out of 400 trials on, 30% haven’t reported results

A new study found that 118 of 400 clinical trials had not reported results four years later in either a journal or on The researchers randomly selected trials that were registered on and listed as completed in 2008. They found that trials were equally likely to report results regardless of whether or not […]

16th July 2014|

Results from trials of vaccines remain unreported

The results of clinical trials of vaccines involving 11,527 people remain unreported and unused according to a recent study in The BMJ. Researchers looked at 384 vaccine trials registered in at least one of several clinical trial registers between 2006 and 2012. They found that trials took an average of 26 months after ending to […]

10th July 2014|

EMA postpones decision on clinical trial data sharing policy

The European Medicines Agency (EMA) just announced that it now won’t finalise its policy on sharing data from clinical trials until October. This is the policy that hundreds of you wrote to them about in June.

The Management Board of the EMA was going to finalise the wording of the policy by mid-July so the policy could […]

9th July 2014|

Dalhousie students form an AllTrials student society

In March, students at Dalhousie University in Halifax, Nova Scotia, Canada formed the Dalhousie AllTrials Student Society to raise awareness about clinical trial transparency.

One of the first things they did was ask a major cancer research society in Canada to join AllTrials. Since then, both the Canadian Cancer Research Alliance and Canadian Cancer Society have […]

8th July 2014|

Support the HRA’s proposals

We must support the NHS Health Research Authority’s (HRA) new proposals to promote research transparency.

Last year the HRA consulted on making failure to register a breach of ethical approval. All of your responses were central to them adopting this good proposal. Now they are consulting on proposals to require trial sponsors to make a declaration […]

7th July 2014|

Building the AllTrials campaign in Spain and Latin America

The Iberoamerican Cochrane Centre is taking up the AllTrials campaign in Spain and Latin America. They are going to ask scientific societies, patient organisations and ethics committees in Spain to join AllTrials and will work with their colleagues at Cochrane Centres across Central and South America to reach out to organisations there. They are also going […]

4th July 2014|

PhRMA claims transparency risks damaging public health

Publishing information from clinical trials “risks damaging public health and patient welfare” says the US pharmaceutical industry. The industry body Pharmaceutical Research and Manufacturers of America (PhRMA) made the statement in a letter to Douglas Bell, the chief US trade negotiator for the free trade agreement between the European Union and the USA, the Transatlantic […]

3rd July 2014|