Monthly Archives: June 2015

Public health groups sue FDA for access to trial data

Two public health groups have taken legal action to obtain access to clinical trial information about two new and expensive hepatitis C drugs, Sovaldi and Harvoni, manufactured by Gilead Sciences. A lawsuit was filed by Treatment Action Group (TAG), an AIDS research and policy think tank and member of AllTrials, and the Global Health Justice […]

30th June 2015|

Ongoing judicial review against the Health Research Authority

In March 2015 Richmond Pharmacology launched a judicial review against the Health Research Authority over its work to further clinical trial transparency.

28th July 2015
The Judgment in Richmond Pharmacology’s judicial review against the HRA has been published. The Judge Mr Justice Jay has said that the HRA has a clear legal right to check researchers’ compliance […]

26th June 2015|

Half of trials on high-risk cardiovascular devices remain unpublished

Only one in two clinical trials on high-risk medical devices for heart disease are published in a peer-reviewed journal, according to a new study published in The BMJ. These devices include implantable cardioverter-defibrillators, pacemakers, coronary stents, and artificial heart valves. Researchers searched an FDA database and found information about 177 clinical trials on 106 cardiovascular devices that received […]

24th June 2015|

Head-to-head clinical trials “almost always” back industry sponsor

A new study published in the Journal of Clinical Epidemiology has found that industry-sponsored clinical trials comparing different treatments “systematically yield favourable results for the sponsors.” Researchers looked at 319 trials with over 100 participants published in academic journals in 2011. Of the 182 trials funded by pharmaceutical companies 83% had positive results compared to […]

19th June 2015|

Chief Medical Officer calls for medicines review to restore public trust

Professor Dame Sally Davies, the Chief Medical Officer for England and the most senior health advisor in government, has called for an independent review of the safety and efficacy of medicines.

The review, which started on 17th June, is being conducted by the Academy of Medical Sciences (AMS) and will explore how different sources of evidence […]

18th June 2015|

UK Government cites AllTrials in G7 transparency pledge

The Department of Health has told us more detail behind UK Prime Minister David Cameron’s comments at G7, on the need for trials transparency in public health emergencies.

The new commitment is that whenever a UK Government body funds or co-funds research or work into diseases that are a threat to global health security, that work will […]

11th June 2015|

Prime Minister calls for G7 agreement on clinical trial transparency

To combat the outbreak and spread of deadly viruses like Ebola, UK Prime Minister David Cameron is urging G7 leaders to develop an international agreement to require all clinical trials to be published. The recent Ebola outbreak showed that when data on disease outbreaks is not shared quickly, the disease can get out of control. […]

8th June 2015|

Imiquimod story highlights the danger of hidden trials

A commentary published in JAMA Dermatology has highlighted yet another extraordinary case of unpublished trials.

It looks at the case of imiquimod, widely considered beneficial for treating children with molluscum contagiosum (a viral infection that affects the skin). In fact, 2 large randomised clinical trials have shown imiquimod is neither safe nor effective in these cases.1,2

These […]

5th June 2015|

Europe’s Clinical Research Infrastructures Network joins AllTrials

The European Clinical Research Infrastructures Network (ECRIN) has joined AllTrials, saying “ECRIN promotes transparency in clinical trials, including commitment to publish and commitment to provide access to patient-level data.” ECRIN is a not-for-profit organisation that provides hands-on support and tools for multinational clinical research projects in Europe.

Dr Trish Groves, deputy editor and editor-in-chief, BMJ Open […]

2nd June 2015|