Carl Heneghan, Centre for Evidence Based Medicine and co-founder of AllTrials reviews today’s commitments: “In terms of the principles for responsible clinical trial data sharing, outlined by the EFPIA and PhRMA these are to be broadly welcomed. Yet, there are many details that need to be fleshed out to ensure this is little more than just window dressing. For example, ‘each company will establish a scientific review board that will include scientists and/or healthcare professionals who are not employees of the company,’ should ensure that the stated professionals are independent and free of conflicts. Otherwise, and by stating the obvious, you could end up with key opinion leaders who are not free of conflicts, dominating the review boards.
Some of the statements seem also to be less than what is already being proposed by the European Medicines Agency. ‘Companies will make available CSR synopses filed with regulators on or after January 1, 2014’. Why synopsis, and not the full CSRs, in addition, statements like ‘running to millions of pages’ is unhelpful in the debate and designed to put off those interested in transparency. The release of the important elements of a clinical study report, which are often less than a 1000 pages, should present no barrier to independent scrutiny. Particularly given that redaction of identifiable data elements is a reasonably straightforward process.
Moreover, there should be a duty on companies to explain why they have not released data – in a timely fashion – in response to what is a reasonable clinical question. Otherwise this current document does little to move the debate on clinical trial transparency forward.
The EFPIA and PhRMA should decide whether they are for the release of clinical trial data, which ultimately benefits patients, or not. The current document is clouded in caveats, which would certainly allow a company to refuse a request, simply because they deemed it not to be in their interest.”
Ben Goldacre, author and co-founder of AllTrials: “The industry commitments suggested here are weak and filled with loopholes. They fall way short of the concrete commitments the European Medicines Agency has already made about sharing trial information, and also fall short of recent commitments from GSK and Roche.
The loopholes are especially concerning. EFPIA and PhRMA seem to be suggesting that transparency should only happen for new trials, and reports submitted to regulators after 2014. This will do nothing to remedy the incomplete evidence that doctors and patients are being forced to use right now, on the medicines we use every day and came to market over the past few decades. Sharing trial information going back for at least two decades is vital.
It is also a retrograde step that they suggest only releasing Clinical Study Reports on demand, after a long review process by the company, where they will decide if the applicant is appropriately qualified. The Cochrane Collaboration faced a four year battle to get Clinical Study Reports from Roche on Tamiflu, during which time the company attempted to argue that the Cochrane Collaboration – 14,000 academics producing more systematic reviews than any other organisation in history – were not competent to conduct a systematic review.
There are also some bizarre peculiarities in the details. For example, the suggestion that trial protocols should only be released voluntarily, and on request, after going through a panel run by the company, is extraordinary. This suggests the EFPIA/PhRMA document may not have been thought through carefully. A trial protocol is simply a detailed description of what will be done in a trial, and how it will be analysed. It should be a routinely available public document and, by best practice, made available before the trial even begins.
Overall the proposals here are no meaningful alternative to simple, clear transparency on all trials. Doctors, regulators, and policy makers cannot barter away from the simple full transparency that patients need. All results from all trials for all uses of currently prescribed treatments must be made available, if doctors and patients are to make informed decisions about which treatment is best. Where we have anything short of this, patients are exposed to unnecessary harm.”