MPs: trial transparency ‘unacceptable’
pharmafile | September 17, 2013 | News story | Medical Communications, Research and Development, Sales and Marketing | MPs, Roche, Tamiflu, trial transparency
The House of Commons science and technology committee has delivered a broadside at pharma, branding the general lack of transparency in clinical trials ‘unacceptable’.
“Many of the trials taking place today are unregistered and unpublished, meaning that the information that they generate remains invisible to both the scientific community and the public,” said committee chair Andrew Miller.
“This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk,” he added.
In a report issued today, the committee recommends that all trials conducted on NHS treatments, plus any other trial that receives public money, must be registered and their results published in a scientific journal.
The government “must also do what it can” to make sure that past trials are registered and published – particularly if public funding has been involved.
However, while this might make slightly uncomfortable reading for pharma as it wrestles with the transparency debate, the sector may be cheered by the committee’s stance on the disclosure of data: it is “not in favour of the uncontrolled release of potentially sensitive patient data, even in anonymised form”.
Despite this nod towards the prevalent mood music being played by pharma executives, the influential group of MPs says it wants the coalition to make sure that more information is shared.
“Raw trial data is currently underutilised and could be of significant scientific value if shared in a responsible and controlled way, with the knowledge and consent of patients,” Miller said.
This has long been one of the pinch points in the intense debate over how pharma should make trial data available, with European trade body EFPIA last week slamming the European Medicines Agency’s draft proposals, saying it had ‘serious concerns’.
The essence of the EMA’s plan is that, from next year, pharma companies should release all of their study information for independent scrutiny: the select committee wants the UK government to take its report into account when responding to the EMA.
Roche has welcomed the report, saying it vindicates the company’s own efforts to improve data transparency.
“We provide access to our clinical study reports (CSRs) and analysable patient-level data in a secure environment that ensures patient confidentiality and protects legitimate commercial interests,” the manufacturer said in a statement. “This, as well as our trial registration processes and the publication of summary results, is in line with the committee’s recommendations.”
Roche has previously been criticised by data transparency campaigners for not releasing more information on Tamiflu such as CSRs – something the company says it has now done.
The MPs also noted that the UK was a “particularly challenging” place in which to conduct a clinical trial, in part because of the various approvals required from different NHS bodies, and said the government must “translate its words into effective action” on this.
Adam Hill
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