Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
Industry inches toward consensus on limited sharing as EMA, GSK press for open access.
When it comes to sharing clinical trial data, at one end of the spectrum is the European Medicines Agency (EMA), which has drawn a proverbial line in the sand with its public draft of Policy 70, requiring the same open access through which it has released some two million pages of documents related to agency-approved drugs since 2010.
At the other end, Sanofi CEO Christopher A. Viehbacher has drawn his own line, raising the specter that his company—and possibly others—will cut back on investment in Europe if authorities insist on such open access.
Somewhere in the middle is an emerging consensus within biopharma, judging by the words of a U.S. industry group and the deeds of some companies. That consensus favors some sharing of data, though not to the degree of EMA and organizations like GlaxoSmithKline (GSK), where CEO Sir Andrew Witty has committed the company to transparency through open access to clinical trial data.
Among limited data-sharing initiatives is one announced June 26 by AstraZeneca and Roche. The companies will make selected databases available for study via matched molecular pair analysis that identifies potential structural modifications companies can apply to their compounds to improve their metabolism, pharmacokinetics, or safety, without divulging confidential information about those structures.
“The consortium is open to other large companies,” AstraZeneca and Roche said—and appears to have wasted little time pursing expansion, they might have added.
“MedChemica is in discussions with several other large companies at various stages to join the SALT Knowledge Share consortium,” Al Dossetter, Ph.D., BioChemica’s managing director, told GEN last week.
Asked about the possibility that the consortium could, over time, agree to share wider swaths of data, even patient-level data from clinical trials, Dr. Dossetter sounded less encouraging. “MedChemica’s aim is to explore and find ways to enable sharing and/or collaboration with multiple partners,” he said. “There are many exciting possibilities for the future. Our focus in the short- [to] medium-term will be on the chemistry side of research.”
The companies join more than two dozen limited data-sharing initiatives; the Institute of Medicine (IOM) counted 27 in a March report. Most of these projects address basic or precompetitive research, without the challenges of maintaining confidential patient or corporate information.
One initiative, GSK’s Open Lab in Tres Cantos, Madrid, will by month’s end host 18 visiting scientists who will work with more than 100 GSK scientists at the company’s developing-world disease research center. Since its 2010 creation, Open Lab has handled 29 projects—11 active, 10 set to start soon, and eight completed.
In May, GSK announced the launch of an online system allowing researchers to request access to anonymized patient-level trial data. “GSK has received four research proposals and about a dozen requests for studies that aren’t on the site,” company spokeswoman Melinda Stubbee told GEN. “One is being reviewed now by the panel, the other three are being checked for completeness.”
SAS—which worked with GSK to create its online system—said June 27 it is now building a secure, globally accessible data and analysis environment where GSK would be among multiple drug developers making anonymized trial data accessible online.
AstraZeneca and Roche announced their consortium two days after EMA released Draft Policy 70, “Publication and access to clinical-trial data.” The policy draft promises not to divulge commercially confidential information (CCI), yet pointedly adds that “in general, however, CT [clinical trial] data cannot be considered CCI; the interests of public health outweigh considerations of CCI.”
“Access to CT data in an analyzable format will benefit public health in future,” the draft policy concluded. “It will make drug development more efficient by establishing a level playing field that allows all drug developers to learn from past successes and failures, and it will enable the wider scientific community to make use of detailed and high-quality CT data to develop new knowledge in the interest of public health.”
Among those reviewing Draft Policy 70 is the Pharmaceutical Researchers and Manufacturers of America (PhRMA). In April, PhRMA cheered after one member, AbbVie, along with InterMune struck a blow against open access by persuading the General Court of the European Union to grant an injunction blocking EMA from releasing data from the companies’ clinical trials pending a final decision on the issue.
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.