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Exclusive Life Science Feature expert review committee with oversight and authority over data releases. Anyone receiving the data must sign a data-sharing agreement that describes the use they will make of it. But to establish an independent custodian would require an industrywide effort. GSK's vision of the custodian is an organization modeled on the Structural Genomics Consortium, formed initially by reaching out to all the key constituents and structured to represent all of their interests. "Once we work out some of the issues for ourselves, hopefully a few other sponsors will join in, and we will make some adjustments to accommodate their expectations. And presumably, that will help GSK create a movement to start making the consortium happen," Nisen says. "One of the only ways to get around antagonisms and distrust is to just start making our data available and let others then affirm or refute the conclusions that we've made," says Perry Nisen, senior VP of science and innovation, GlaxoSmithKline. GSK may have some competition in influencing the form data transparency eventually takes. The EMA (European Medicines Agency) is preparing to advance an entirely different approach, in which the agency would be the central arbiter of data release and publication for trials in its jurisdiction. And activist proponents of total transparency would be loathe to surrender the initiative to any company they consider responsible for secreting the information in the first place. Academic institutions may find it particularly difficult merely to participate in a data transparency system, partly because they typically lack the institutional history of open research, but perhaps more importantly because of the costs involved. Nisen says the resources needed to put clinical data into an analytical form according to a common data standard are expensive and perhaps impractical in such institutions, considering the high turnover among their investigators. In the face of those and other issues, Nisen is philosophical, but determined to push ahead. "One of the only ways to get around antagonisms and distrust is to just start making our data available 36 LifeScienceLeader.com October 2013 and let others then affirm or refute the conclusions that we've made. At the end of the day, there will be a benefit, predicated upon data generated to the best of our ability, along with the best analysis possible. And the more we can do that, the more acceptance we will win. We will also have less waste in generating and regenerating data." Nisen says the company is now in related discussions with a few other pharma sponsors about joining its transparency initiative. "I am cautiously optimistic that we'll move forward and they, too, will start contributing." He says GSK has also spoken with "independent parties who could potentially function as independent custodians." OPEN DATA, INNOVATION, AND TRUST Well done is better than well said — according to another Franklin maxim. Inside GSK, Nisen and his team turn words into action, coordinating a flexible group of personnel largely drawn as needed from the company matrix. "We receive team support, policy support, and operational support from the company," he says. "We can put enough resources behind any particular project to make it work. And we have a commitment to data transparency as a high priority from the top of the organization down." One of the ongoing responsibilities of Nisen's group is to use data sharing as a tool for clinical trials improvement. To start with, it teaches investigators in new trials how to prepare the clinical data they help generate for future sharing, including publications. But data transparency also molds the operations, regulatory routines, policy development, and overall planning of trials — essentially forcing an innovative approach to the clinical development. Outside GSK, however, the people running small development companies may well wonder, Why should I add this to my plate? Why should I make my data transparent? "For all the same reasons that we do — to leverage the opportunity to cross-analyze and harmonize the information," answers Nisen. "If you move to common standards, you have to give a little to get more back, on some level. But it will not be so easy for small companies to do that unless, from the inception, they adhere to a common standard and leverage the information to model and simulate what they want to do. It might make for much better studies on their part as well, I would think." It would also not hurt the partnering prospects of small companies to be a part of an industrywide collaboration or consortium in data transparency. Doing good, being seen doing good, plus doing what you say should be done — not a bad equation for entrepreneurs out to change the world. If nothing else, joining the data transparency movement will help remove the stifling insulation that all too typically surrounds young companies. Nisen cites the company's chief executive to summarize why GSK has chosen transparency as the right thing to do. "One of the fundamental pillars that Andrew Witty has articulated from the very beginning was building trust. And one of the key ways to build trust, I would say, is to be transparent, to make our data available — just walking the talk." The rationale of trust seems sound for any clinical trials sponsor, no matter how large or small.