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Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\/Authors' Reply to Harpaz et al. Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\
by
DuMouchel, William
, Juhlin, Kristina
, Lindquist, Marie
, Shah, Nigam H
, Caster, Ola
, Harpaz, Rave
, Norén, G Niklas
in
Benchmarks
/ Consumer protection
/ Experiments
/ Health sciences
/ Methods
/ Performance evaluation
/ Pharmaceutical industry
/ Side effects
2015
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Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\/Authors' Reply to Harpaz et al. Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\
by
DuMouchel, William
, Juhlin, Kristina
, Lindquist, Marie
, Shah, Nigam H
, Caster, Ola
, Harpaz, Rave
, Norén, G Niklas
in
Benchmarks
/ Consumer protection
/ Experiments
/ Health sciences
/ Methods
/ Performance evaluation
/ Pharmaceutical industry
/ Side effects
2015
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Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\/Authors' Reply to Harpaz et al. Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\
by
DuMouchel, William
, Juhlin, Kristina
, Lindquist, Marie
, Shah, Nigam H
, Caster, Ola
, Harpaz, Rave
, Norén, G Niklas
in
Benchmarks
/ Consumer protection
/ Experiments
/ Health sciences
/ Methods
/ Performance evaluation
/ Pharmaceutical industry
/ Side effects
2015
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Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\/Authors' Reply to Harpaz et al. Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\
Journal Article
Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\/Authors' Reply to Harpaz et al. Comment on: \Zoo or Savannah? Choice of Training Ground for Evidence-Based Pharmacovigilance\
2015
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Overview
Norén et al. argue that signal detection is fundamentally a prognostic activity. [...]evaluation strategies should aim to emulate a prospective analysis of signal detection in lieu of a commonly applied yet unsatisfactory approach of retrospective analysis based on well established associations such as those comprising the Observational Medical Outcome Partnership (OMOP) [2] and EUADR benchmarks [3]. [...]the status of a recently labeled ADR (positive control in some benchmarks) may be revised based on new refuting evidence. [...]the increased level of uncertainty associated with experiments based on such recently labeled or emerging ADRs cannot be ignored. [...]consideration of timeliness does not eliminate the need to distinguish between emerging and established adverse drug reactions; we would not recommend a comparison of statistical signal detection methods based on how early in the post-marketing phase they signalled adverse drug reactions that were known already from pre-marketing clinical trials.
Publisher
Springer Nature B.V
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