Roche says it will not relinquish control over access to clinical trial data -BMJ

By Zosia Kmietowicz

Campaigners for full transparency of all clinical trial data have responded with incredulity to a statement from the drug company Roche saying that it would continue to hold back certain information and results from research into its drugs.

Tracey Brown, director of the charity Sense About Science, said that the company was “on another planet.”

In January Brown helped to set up the AllTrials campaign (www.alltrials.net), together with the BMJ and others, for all clinical trials to be registered and reported in full.1

So far the campaign has collected 37 889 signatures for its public petition to put pressure on researchers, funding bodies, and institutions to take action on the issue. And more than 180 organisations have signed up to the initiative, including the UK National Institute for Health and Clinical Excellence, the Wellcome Trust, the UK Medical Research Council and medical royal colleges, the drug company GlaxoSmithKline, and more than 90 patient groups.2

Researchers from the Cochrane Collaboration have been waiting for three years for Roche to honour a promise it made in the BMJ in 2009 to give them access to full results from research on oseltamivir (Tamiflu) to establish the drug’s effectiveness and safety (bmj.com/tamiflu).3

Last November they rejected an offer from Roche to allow an advisory board to review what type of analysis of data on oseltamivir would be useful to them, saying that they were waiting for the company to fulfil its promise to them.4

The latest statement from Roche, issued on 26 February, said that the company would continue to vet requests for data that were not publicly available and would allow access only to those it approved.5

It said that any information that was released through this channel “will be edited in consultation with Roche to ensure patient confidentiality and to protect legitimate commercial interests, including intellectual property rights.”

Brown described Roche’s response to the campaign for transparency as “poor,” adding “Which bit of ‘all’ and ‘trials’ do they not understand?”

She said, “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Thousands of people are calling for all clinical trials to be registered and the findings published. Patients, researchers, and practitioners are petitioning organisations and regulators for change all over the world. Just today the UK’s Health Research Authority signed up, joining a throng of research organisations, regulators, patient groups, and professional bodies.”

Commenting on the statement, Carl Heneghan, director of the Centre for Evidence-Based Medicine in Oxford, told the BMJ that three in four of the people named on the advisory board are known for their links with drug companies. He added, “What they are planning undermines the notion of what transparent data is and what systematic reviews are about.”

Tom Jefferson, an independent epidemiologist with the Cochrane Collaboration, said, “Whoever applies [to the Roche advisory board for data] is likely to end up with redacted incomplete CSRs [clinical study reports] like the ones GSK sent us. This will confuse honest reviewers but provide those who want to prove this or that with a full alibi.”

He added, “No real independent researcher in their right mind will accept being told what to do and how to do it by pharma KOLs [key opinion leaders]. The time for games is past.”

In a separate move the Association of the British Pharmaceutical Industry (ABPI) announced that it was putting in place new measures to monitor compliance with the provisions on clinical trial transparency in its Code of Practice. These stipulate that current and future trials must be registered within 21 days of enrolling the first patient, and results must be published within one year of marketing authorisation or one year from trial completion for marketed products. An independent provider would monitor compliance, and the association would be responsible for reporting non-compliance to the Prescription Medicines Code of Practice Authority.

Stephen Whitehead, chief executive of the association, said that the move illustrated how seriously the association took the issue of transparency in clinical trials.

He added, “On the issue of historical data, we also want to ensure that we work collaboratively with all health stakeholders and international colleagues to agree a pragmatic approach which is in the interests of patients while protecting the commercial research model. The pharmaceutical industry has always accepted that making data more transparent is important, but all parties must now decide together how exactly this is acthieved.”

Iain Chalmers, coordinator of the James Lind Alliance (an alliance of patients and clinicians set up to identify priorities for research), commented: “The measures that the ABPI is introducing to monitor compliance with transparency in future are to be welcomed. Unfortunately, uncertainty remains about whether the ABPI will show leadership in promoting the ‘liberation’ of inadequately reported clinical trial data from the past, as GSK is now committed to doing.”

Notes

Cite this as: BMJ 2013;346:f1374