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 […]
A BMJ Open study has found that results which were posted on a now closed industry-sponsored clinical trials register – clinicalstudyresults.org – are either scattered across various other registers or no longer publicly available. Clinicalstudyresults.org was created in 2005 by the US trade group, the Pharmaceutical Research and Manufacturers Association for pharmaceutical companies to post […]
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 […]
A new study found that 118 of 400 clinical trials had not reported results four years later in either a journal or on ClinicalTrials.gov. The researchers randomly selected trials that were registered on ClinicalTrials.gov and listed as completed in 2008. They found that trials were equally likely to report results regardless of whether or not […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]