If there is nominal consensus around the need to make data from clinical trials more widely available, a workshop held last month at the European Medicines Agency showed how deep the divisions remain between – and in some cases within – industry, regulators and transparency campaigners over exactly how much data should be released and how.
As Hans-Georg Eichler, the EMA’s senior medical officer, made clear at the workshop in London, “this process is irreversible”. At the same time, the Agency was realistic about the prospects of reaching any firm conclusions from the discussions, an EMA report on the meeting noted.
Hence its decision to move forward by establishing broadly constituted advisory groups to suggest policies that “the Agency can adopt or politely refuse” in five key areas relating to data transparency: protecting patient confidentiality; clinical-trial data formats; rules of engagement; good analysis practice; and legal aspects.
Full information on the proposed advisory groups, including dates and application processes, will be available on the EMA's website this month.
The Agency plans to take final advice from each advisory group by 30 April 2013; to complete and issue for public consultation a draft policy on data transparency by 30 June; and to publish a final policy on 30 November 2013, which would come into effect on 1 January 2014.
“It was clear to us that we would have to cut one big problem into several smaller ones, each to be tackled by experts in that arena,” Eichler told the workshop participants. “That is where you come in.”
The gulf in opinions was clear from the EMA’s account of the expert-panel debate that formed the centerpiece of the transparency workshop.
For example, Peter Gøtzsche, director of the Nordic Cochrane Centre – which has spearheaded efforts to make Roche publish the complete raw dataset on its antiviral Tamiflu (oseltamivir) – argued that the current system allowed industry to act as its own judge throughout the drug-development process.
“Companies design and carry out trials, they analyse them and interpret the data, often introducing bias,” Gøtzsche told the workshop. “If that is not enough, data from some trials may not even be published.”
For their part, patients “take part in clinical trials to benefit science and future patients”, he added. “They do not take part to benefit the shareholders of pharmaceutical companies”.
As to pharmaceutical companies’ concerns about protecting their intellectual property rights, Gøtzsche suggested that if commercial success depended on withholding data doctors needed to make informed prescribing decisions, there was something wrong with healthcare priorities.
An alternative would be for drug development to be publicly funded, especially since most medical breakthroughs came through publicly funded research and development, Gøtzsche proposed.
He did acknowledge the potential for sub-standard analyses of published clinical-trial data. “By requiring people to register a protocol, we can look at the hypotheses and tests, and guard against too many fishing expeditions,” Gøtzsche commented.
Nonetheless, he insisted, the data should be “available to everybody. After all, often it is those without qualifications that reveal the most interesting things, such as investigative journalists … The more eyes that look at the data, the better.”
Case by case
By contrast, Susan Forda, chair of the European Federation of Pharmaceutical Industries and Associations’ Scientific, Regulatory and Manufacturing Policy Committee, said the industry wanted to see data access reviewed on a case-by-case basis.
Decision-makers should take a range of factors into account, Forda said: the nature of the product, for example, the data presented, the product’s stage in its lifecycle, and the method of data release.
"I would be terribly worried about making all data freely available,” Forda commented.
“For example, if inappropriate data analyses were picked up by the media early in a product’s lifecycle, it could confuse doctors and prevent patients from receiving effective medicines. Analyses should also be defined and reviewed, allowing interested parties to comment.”
EFPIA is also against releasing information on withdrawn medicines or those subject to a negative opinion from regulators. “This could damage the future interest of the product if it is resubmitted at a later date with additional data or submitted outside the EU,” Forda explained.
Neil Weir, who sits on the EFPIA's Research Directors Group, suggested that an elegant solution might be to appoint an independent assessor who could decide which data should be accessible.
“In terms of the greater good, we must find a balance between fostering great science and an acceptable commercial environment,” Weir commented.
He also argued that, by seeking more collaborative relationships with external experts in research and development, industry was already widening data access. “By involving more academic colleagues, many more people will be looking at our data.”