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Emerging Safety Science Workshop Summary (2008) / Chapter Skim
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10 The Future of Safety Science
Pages 106-114

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From page 106...
... Prediction that can detect potential problems in advance of clinical testing or market approval will allow for safer delivery of medicines, vaccines, and medical devices, and even the performance of safer surgeries. Traditional drug safety detection methods have generally depended on animal testing, with the assumption that the results of these tests can be indicative of what will happen This chapter is based on the presentation of Ronald Krall, Senior Vice President and Chief Medical Officer, GlaxoSmithKline, and the contributions of several other workshop participants.
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From page 107...
... There are also examples of their being used to prevent adverse events in humans and of markers being identified to help monitor for effects in humans, thus minimizing the chances of drug-induced injury. Finally, these techniques are being used to gain additional information about cellular pathways and signaling, thereby increasing understanding of why certain events occur and offering insights into potential new targets.
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From page 108...
... This example showed it is possible to search for and identify events of interest in large health care databases using a prescribed set of tools and methodologies, just as events are found using data collected from spontaneously reported adverse events. Furthermore, such an analysis can expand on the findings from a spontaneous adverse event reporting system.
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From page 109...
... Looking to the future, Krall and several other workshop participants reviewed a number of ways to meet the challenges involved in realizing the goal of an active surveillance system. Enhancing Data Sharing Peter Corr, retired from Pfizer, echoed the importance of sharing data and technology.
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From page 110...
... Having been involved over the past 2 years in a GSK initiative aimed at linking quantitative clinical data with basic science information, he has found the biggest challenge to be the lack of data standards within basic science databases and the lack of consistent names for drugs being studied. He noted that even working with data from GSK's own databases has been difficult, in part because the various companies that merged to form GSK each had their own formats, and standardizing the data has been
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From page 111...
... The way an electronic health record is implemented in a health care system has a great influence on which data actually exist and on how easy it is to find associations in those data. Instituting Electronic Record Keeping Krall suggested that to capture medically important information that is not being captured in current health care record systems, the best approach would be to institute electronic health records.
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From page 112...
... Addressing Issues Inherent in Data Sources Panaccio stressed the importance of understanding how to interpret information collected from a health care plan database. Because the population of that database will not be the same as the general population, it is useful to examine cohorts within the health care plan in an effort to understand what the patients in these cohorts looked like before the drug of interest was marketed -- for example, what sorts of adverse events were reported.
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From page 113...
... This sort of data challenge has been met in other industries, he said, and it will be important to look at these other industries and learn how they have been successful through the use of computer modeling and other technologies. Gishizky also suggested that an appropriate metaphor for what is needed to link the basic sciences to the clinical setting is the Rosetta stone: researchers must find some way to translate information from the basic sciences into the clinical setting and vice versa.
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From page 114...
... . Along the same lines, Frazier commented that health care providers will not actively follow the search for biomarkers and adopt each as it is discovered.
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Key Terms

  • emerging safety
  • adverse events
  • adverse event
  • active surveillance
  • electronic health

  • health record
  • health records
  • postmarket surveillance
  • clinical trials
  • event reporting

  • basic sciences
  • clinical setting
  • clinical data
  • clinical safety
  • care databases

  • traditional animal
  • instituting electronic
  • serious adverse
  • traditional approach
  • reported adverse

  • record data
  • care plan
  • data mining
  • spontaneously reported
  • workshop demonstrated

  • identify events
  • active postmarket
  • science work
  • active monitoring
  • science center


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