PhRMA says it does not oppose data-sharing access, but seeks limited or “responsible” sharing, which it defines as protecting patient privacy, maintaining the integrity of the regulatory review process, and preserving biomedical research incentives.
“It’s possible for companies to perform data sharing, particularly with well-trained scientific researchers. But it has to be done in a way that protects these three principles,” Jeffrey K. Francer, assistant general counsel for PhRMA, told GEN. “There’s a lot of potential benefit, and also some potential risk, with data sharing and regulatory agencies disclosing clinical trial data.”
A better alternative, Francer said, is for industry to develop standards for limited data sharing with groups involving multiple stakeholders, like Harvard University's Multi-Regional Clinical Trials (MRCT) Center, which drew some 200 participants to a May 17 conference; and IOM, which held a workshop last October. IOM is now developing a consensus study focused on open availability and use of trial data.
Not all within industry share PhRMA’s view. Last October, GSK’s Sir Andrew Witty said his company will make available to researchers details of data from its clinical trials, as well as 200 compounds that had shown promise in treating tuberculosis.
It’s easy to dismiss GSK’s moves as PR-driven. Whatever the motivation, the company has stepped up its transparency effort this year: In May, GSK launched its “open innovation” online platform, through which it will share clinical trial data on a password-protected basis.
Sir Andrew Witty’s stance differs from that of his successor as president of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Sanofi’s Viehbacher has criticized EMA’s data-sharing stance, since it includes access to the processes by which compounds are manufactured—where companies, he argues, often focus proprietary know-how against rivals.
"If all of this stuff is laid out, then we could have competitors from any country, particularly outside of Europe, suddenly start looking at our manufacturing process and we could suddenly find ourselves with some non-European competitors,” Viehbacher told reporters in remarks made to European news outlets in June.
Speaking as Sanofi CEO, he added: "If I was to say where would I put the next euro of investment, I would say either the next euro of investment would go to the United States or to emerging markets."
Then again, Sanofi is already trying to cut R&D in its headquarters country of France, where labor and government opposition has shrunk the total of jobs slated for elimination from the original 2,500 to 900, and further to 207, as of last week, union leaders told Reuters.
Europe has long wrestled with trial data-sharing; in addition to GSK and EMA, another key advocate has been the BMJ, whose deputy editor Trish Groves on May 7 declared: “The movement towards open science is gathering pace, driven by scientific and ethical imperatives—not simply by the technological possibilities. In medicine such openness has real potential to benefit patients and society.”
Significantly, BMJ seeks its own form of limited sharing, saying that access need not be public, suggesting registration for some data uses (personal details, proposals for further data analysis and reuse, and commitments to publish and share new data), and even subjecting open access to approval by an independent panel.
That suggests, however, that as data sharing evolves during the next few years, it is likely to be limited, with a third party mediating requests to prevent privacy lapses or releases of confidential business information. While much is yet to be determined, that third party could stem from IOM or MRCT, or from a consortium of these and others committed to data access.