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Exclusive Life Science Feature Compared to such a reality, the imagined scenario amounts to way such a rich and deep source of data," Nisen says. "We were data transparency. It may not be the naked transparency sought getting ourselves organized to meta-analyze information, to validate by Internet hackers and activists, where any person could obtain methodology, to interrogate, and explore everything from placebo clinical data like readers of Gutenberg's Bible received scripture. data to signals we would see in unexpected ways. But it was frustratQuite frankly, the custodial model of transparency serves the ing not to have access to the data in a straightforward way because industry's interests in avoiding the chance that someone could of varying data standards, multiple databases, and so on." wildly misinterpret such data to suit a nonscientific agenda, a disAlthough GSK has worked for years to establish standards that tinct and even inevitable possibility. Yet the model, as expounded enable internal company access to patient-level data, Nisen says it by Perry Nisen, senior vice president of science and innovation at still lacked an integrated sense of all the relevant data generated GlaxoSmithKline, actually seems to give sponsors no real place outside the company. Access to the universe of scientific inforto hide when science calls for a reexamination of the data genermation from outside trials was becoming essential, he says, parated in their human trials — an amazing change of climate for the ticularly at the broader management level such as the company's industry should it become safety board, which he cothe new reality. chairs. A basic rationale for the On the other side of data transparency movethe equation, it became ment is that the data sumapparent that the often maries published by sponnegative and poor-quality sors do not always accumeta-analyses of GSK's trirately reflect the underals by people outside the lying data. But if sponcompany suffered from sors can distort the data lack of data it controlled in summary, why cannot and traditionally held their critics do the same? confidential. Custodial Perry Nisen, senior VP of science and innovation, GlaxoSmithKline Therein lies a key argutransparency appeared to ment for the independent be the only logical solucustodian. tion. Nisen's argument for a custodian does not rest solely on the "We have an obligation to share our data," asserts Nisen. "Even question of summary error or bias, but also on the idea of refereed back in med school, I saw how powerful and useful a clinical trial access to a massive data pool from which researchers can draw with large data sets could be, as well as impossible to duplicate. To great power in their quest for safer and more-effective medicines. generate such magnificent amounts of data and not have a means The custodian's role thus becomes more a facilitator of research for investigators and scientists to explore it in all kinds of ways than a simple gatekeeper — ensuring shared data goes to qualiseems so misguided. So here at GSK, one of the issues that espefied scientists on bona fide scientific quests, rather than amateur cially matters to me is data transparency — making anonymized sleuths with axes to grind. patient-level data available, ultimately in the interest of society — An article published in the Aug. 1, 2013 edition of NEJM gives because it's the right thing to do." a detailed account of GSK's current and planned data-sharing A FEEDBACK OF BENEFITS program. Here, we are more concerned with the "why" than the Three main reasons may justify the adoption of data transparency "what" of the company's data-transparency initiative. Why would from the industry's perspective: the potential for validation by mula single company, acting on its own, go against the industry grain tiple analyses of original observations or interpretations, the unleashto push for transparency? ing of data resources for researchers, and the advancement of evoluTRANSPARENCY, RIGHT VS. WRONG tionary improvements in future clinical trials and data. Without such Ben Franklin believed in "doing well by doing good" and suggestaccess to clinical trial data, each trial remains a closed book, locking ed it is not enough to do good; you should be seen doing good. up a wealth of irreplaceable information. "How many times can you Similar practicality and honesty combine to explain GSK's reasons reproduce a large clinical Phase 3 trial that involved 38,000 people? for advocating and implementing the industry's first companyIt's not a doable thing," says Nisen. "Companies are unlikely to repeat initiated system for voluntarily disclosing patient-level data from trials, especially the larger, late-stage clinical trials, just because of the its clinical trials. enormity of the investment to generate that data in the first place." "I've always been struck by the duplication and inefficiency in But if data transparency is the answer to how companies can have clinical development — the inability to analyze in a meaningful their trials and use them, too, it raises many other questions. Nisen "I've always been struck by the duplication and inefficiency in clinical development." 32 LifeScienceLeader.com October 2013