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NEWS STORY

UK MPs call for all historic trial data to be open, NICE and regulator must share information

03/01/2014

British members of parliament on Friday called for all historic drug trial data to be made public for medicines currently in use expressing concern information is routinely withheld from doctors, while stressing formal information-sharing should be set up between NICE and drugs' regulator the MHRA.

In a report published on the UK parliament's website, the Public Accounts Committee says doctors are "unable to make informed choices about the best drugs to treat patients because historical trial data is closed for public inspection", while also criticising the Medicines and Healthcare Products Regulatory Agency (MHRA) and the UK's cost-effectiveness body NICE for failing to routinely share information.

 

The report adds: "There have been recent announcements by the European Medicines Agency (EMA), and some manufacturers, to improve access to information about clinical trials but none adequately addresses the issue of incomplete disclosure throughout medicine.

 

"Opening up information about all clinical trials to medical researchers would support the work of regulators by permitting thorough, independent external review by doctors and researchers."

 

The MPs say this now presents a serious problem because drugs in use came on to the market, and were therefore researched, over preceding decades. "None of the latest proposals from regulators or industry adequately addresses the issue of access to the results of trials from previous years on the medicines in use today," they argue.

 

The report says the Department of Health should take action to ensure that the full methods and results are available to doctors and researchers for all trials on all uses of all treatments currently being prescribed, and should also ensure there is clear and frequent audit of how much information is available and how much has been withheld.

 

The report says scope for independent scrutiny of a drug's effectiveness is undermined by the fact that the full methods and results of many clinical trials are not made available to doctors and researchers.

 

The problem of non-publication of clinical trial results has been known since the mid-1980s, it adds. "We also heard evidence that trials with positive results are about twice as likely to be published as trials with negative results."

 

While several clinical trial registries have been established, none covers all clinical trials on all uses of all treatments currently being prescribed worldwide. There have been recent announcements by the EMA and some manufacturers, to improve access to information about clinical trials "but none adequately addresses the issue of incomplete disclosure throughout medicine".

 

It goes on: "Opening up information about all clinical trials to medical researchers would support the work of regulators by permitting thorough, independent external review by doctors and researchers."

 

The DH and the UK's drugs' regulator the MHRA should ensure that both historic and future trials are registered on an appropriate registry and that the full methods and results of all trials should be available for wider independent scrutiny, "beyond the work undertaken by regulators during the licensing process".

 

Earlier this week, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) announced they had begun to operate the principles they had agreed in mid-2013 for what they term "responsible clinical trial data sharing".

 

Under this policy, researchers can ask for access to patient level data, protocols and clinical study reports for new medicines approved in the U.S. and EU after the start of this year.

 

Friday's report also criticises the UK's NICE and the MHRA for failing to routinely share information provided by manufacturers during the licensing process. When applying for a licence, manufacturers have a legal obligation to provide all the information on the safety and efficacy of a medicine that is required by European regulators.

 

"However, NICE does not have statutory powers to demand information from manufacturers, in contrast to the Institute for Quality and Efficiency in Healthcare in Germany, which performs a similar role to NICE," it adds.

 

NICE seeks confirmation from the medicine manufacturer's UK medical director on the completeness of information, but this may not include all clinical trials in other parts of the world, not least because UK medical directors may themselves not have full information, according to the MPs.

 

The report says the MHRA confirmed there was no legal obstacle that would prevent it from sharing information with NICE. "However, there is no routine sharing of the information provided by manufacturers to regulators as part of the licensing process with NICE. This leads to the risk of omissions and duplication in the collection of evidence."

 

The report says NICE should ensure it obtains full methods and results on all trials for all treatments which it reviews, including clinical study reports where necessary and make all this information available to the medical and academic community for independent scrutiny.

 

The MPs recommend that NICE and the MHRA should put in place a formal information-sharing agreement "to ensure when NICE appraises medicines it has access to all of the information provided to regulators by the manufacturer during the licensing process".

 

Bina Rawal, research, medical and innovation director at the Association of the British Pharmaceutical Industry (ABPI) said in a Friday statement published on its website: "The ABPI is a strong advocate for transparency in clinical trial data and the role it plays in improving patient care.

 

"It is misleading to suggest that the pharmaceutical industry routinely withholds clinical trial data from doctors and researchers."

 

He said that in late 2013, an ABPI commissioned study was published in a peer reviewed journal. This study highlighted a trend of increasing levels of disclosure for industry-sponsored clinical trials, with almost nine out of 10 of all industry sponsored clinical trials disclosed by Jan 31, 2013.

 

"The research covers new medicines approved between 2009 - 2011, which includes trials conducted over the preceding 10 or more years - i.e. during the entire development programme."

 

He said the ABPI recognises there is still work to be done and "we are continuing on a journey to achieving greater clinical trial transparency. The ABPI has made available a new clinical trial disclosure toolkit to assist companies and will continue to engage with key stakeholders on this issue."

 

Source: www.apmhealtheurope.com


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