GlaxoSmithKline (GSK) has declared its support for the AllTrials campaign, which calls for the publication of all clinical trial results.

In addition to its existing website detailing clinical trial results, the company will now publish all the clinical study reports (CSRs) it sends, or has sent, to regulators.

The support of a leading pharmaceutical company increases the momentum of the AllTrials campaign, which is supported by the BMA, the Cochrane Collaboration, and other medical bodies.

Triggered by the ‘Tamiflugate’ controversy over the non-disclosure of clinical trial data relevant to Roche’s blockbuster antiviral, AllTrials has become a key issue for the pharmaceutical industry.

According to GSK, all clinical trials sponsored by the company are registered, and the results disclosed, on a public website that has details of 5,000 drug trials.

The company has now committed to publish all the CSRs it uses to apply for approval from regulatory bodies such as the EMA.

Each CSR will appear on GSK’s clinical trials website when the drug in question has been either approved or discontinued, and the trial data have been published.

GSK will deal with patient confidentiality issues – cited by some companies as a reason for non-disclosure of trial data – by removing patient information from the CSRs before publication.

In addition, the company has said it will publish CSRs for all of its existing approved medicines. This will require work by a dedicated team over a number of years, starting with the most prescribed drugs.

Ana Nicholls, Healthcare Analyst at The Economist Intelligence Unit, noted that GSK paid a $3bn fine in the US in 2012 after admitting that it had withheld safety data on its antidepressants. “By signing up to alltrials now, GSK takes back the moral high ground,” she commented.

The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.