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NonRequested Distribution: (1) Outside County Non-Requested Copies Stated on PS Form 3541: 0/0; (2) In-County Non-Requested Copies Stated on Form 3541: 0/0; (3) NonRequested Copies Distributed Through the USPS by Other Classes of Mail: 503/450; (4) Non-Requested Copies Distributed Outside the Mail: 798/2,050 E. Total NonRequested Distribution: 1,301/2,500 F. Total Distribution: 27,673/28,933 G. Copies Not Distributed: 168/150 H. Total: 27,841/29,083 I. Percent Paid and/or Requested Circulation: 95.30%/91.36%. 34 LifeScienceLeader.com Exclusive Life Science Feature says GSK's goal is to publish all of its past trials, going back even before its merger — but how feasible is the goal? "The further we go back, the harder it is because of paper patient report forms and the ability to just track down all the bits of data and get them in shape to anonymize them," he replies. Similar limits apply to how far back in development data transparency may reach. "In the discovery space, we and all other sponsors have a way to go in making data available. Arguments could be made for sharing a lot of our validation work," says Nisen. "With how much we all invest separately to validate and revalidate preclinical data, we could pool our results — and then let the winner get ahead with the best molecule, the best studies, and the best indications." On the clinical side, Nisen says companies could share a treasure trove of data about placebo effects, ranges of normal variation, validating methodology, and so on. "It is a shame we don't make such data more available to investigators." The payoff for doing so, he says, could be nothing less than a leap in drug safety and efficacy. "Increasing benefit to risk, understanding disease, understanding the range of normal response — all that and more is possible once we unlock the data. We could apply signals, measures, and even methodology that could assess human response using biomarkers, in vivo or in vitro models, or other predictors of toxicology and efficacy." Companies could do a lot together to reach the goal, and some efforts are under way to set up "cloud sharing" and other cooperative programs for exchanging commonly useful data. But Nisen makes the point that the issue of transparency is not restricted to pharmacompany sponsors. "There are lots of studies undertaken in academia where we should be able to see, cross-analyze, and interrogate the data." An independent custodian would maintain a platform for the broadest possible inclusion of all sponsors' data, he believes. "We hope to move to a situation where an independent custodian would have oversight of which academia and sponsors could make their data available, preserve anonymity of patients, ensure a reasonably legitimate scientific question is being asked, and verify the research teams are equipped with the necessary IT and support to handle and analyze the data. Without those protections, one of the risks is nonqualified people using our data to make nonscientifically valid assertions about benefit and risk," he says. GSK BLAZES THE TRANSPARENCY TRAIL According to Nisen, the company began it efforts toward data transparency prior to his arrival in 2001. Frank Rockhold, now senior vice president, drug development sciences, and others inside the company started to work internally and externally on establishing a common database and standards and dealing with issues such as patient privacy and informed consent. Actual sharing of data began in the same time frame with GSK trials of medicines for developing-world diseases such as TB and malaria. Finally, last May, the company made anonymized patient-level data available from more than 200 studies "within certain boundaries" on the GlaxoSmithKline Clinical Study Requests website (https://clinicalstudydata.gsk.com), and Nisen says it will continue to expand its program, doubling the number of studies available by the end of the year. GSK has also committed to publishing clinical study reports (CSRs) of its marketed and terminated/failed medicines and the detailed summaries and interpretation of results from its clinical trials. Beginning in December, more than 1,500 reports will be made available over a two-year period. "It started in Europe, and by December we'll be putting out thousands of the clinical summary reports." Meanwhile, the company has been working with SAS to build the analytical system where this patient-level data can be made available on a central hub database, along with a deployed model where outside investigators can have access to data, once their request has been approved by an independent panel. GSK's first step toward implementing the broader custodial idea was to establish its own October 2013