The GSK Clinical Study Results Database: Site Utilization Metrics for a Large Public Database
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The GSK Clinical Studv Results Database: Site Utilization Metrics for a Large Public Database B a c k p z i d Establishing additional mecha-
Craig A. Metz, PbD Vice President, Regulatory Affairs, GlaxoSmithKline. Research Triangle Park. North Carolina Frank Rockbold, PbD Senior Vice President. Biomedical Data Sciences. GlaxoSmithKline,Research Triangle Park, North Carolina
Andrew Freeman, BSc Head, R6.D Policy. GlaxoSmithKline,Research Triangle Park. North Carolina
Key Words Public clinical study results database Correspondence Address Craig Metz. GlaxoSmithKline,5 Moore Drive (5.5200). Research Triangle Park, NC 27709 (email: Craig.a.metz @gsk.corn).
nisms for providingpublic infmation on dinical studies being conducted and d t s jbm completeddinical trials is a topic of significant public debate. lhis nport p d d e s the experience to date with utilization of the GlaxoSmitMine d i n i d study d t s database (GSK CSRD),aurently the hugest of the single-sponsos; publidy acccssiMe databases with information jbm 2,635 studies involving 59 promccts. Methods: Databas&!quaies were conducted to evaluate the routes andFequency of databaseacccss over a =-month period fdlowing GSK CSRD launch. To evaluate the potential for meanin@ clinical data cxt~ction duringa site visit, quaies were conducted to examine the number of pages accessed and the amount of time spent on the database duringan individual visit. Results: The number of user
INTRODUCTION One of the most significant continuing global public health policy debates of our time involves the desire for increased transparency of clinical trial information. The need to establish additional mechanisms for providing public information on clinical studies being initiated and the results from completed clinical trials has been a relatively constant topic of discussion among study sponsors and key stakeholder groups over the past two to three years. The current drive to define a new and much broader paradigm for sharing information regarding clinical trials arose amid events that drove the evolution of public perceptions/concerns that important clinical data (eg, the risk of suicidal ideations in pediatric patients receiving off-labe1 antidepressant medications: the increased risk of cardiovascular events in patients treated with rofecoxib [Vioxx@])was deliberately kept out of the public domain by the study sponsors. This perception, coupled with significant public
sessions on the database is increasing steadily over time as more pmducts/studiics have been added to the GSK CSRD.Over time, the individual number of sesSi0)ls involving the review of six or m m CSRD pages (ie, one study summay) or gnata than one minute in h t i o n has increased substantially ConclusionS:Access of the GSK CSRD has increased mbstantially since launch. Although aurent data indicate that a distinct majm'ty of sessions a n not likdy to lead to the txtmction of meaning@ clinical information, the absdute number of individual sessions where there is likdihood that meanin& data may have been extm
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