Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.

Study type

• Study topic:
  Other
• Study topic, other:
  Signal detection procedure
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Population studied

• Short description of the study population:
  N/A
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To evaluate whether statistical signal detection in spontaneous reporting data can lead to earlier detection of drug safety problems and to assess the additional regulatory work entailed.
• Outcomes:
  To quantify the benefit that can be obtained by adding PRR signal detection to established pharmacovigilance methods. It means not only whether PRR methods can detect ADRs but with whether they can detect ADRs earlier than the other methods. The risk or regulatory resource cost of adopting the PRR procedure. It means the effort involved in assessing the many other SDRs that will arise but prove to be unrelated to any pharmacological effect of the product.
• Data analysis plan:
  The distribution of delays between SDRs and signals from other pharmacovigilance methods is presented as Kaplan-Meier curves and confidence intervals (CIs) for statistics based on such curves using standard techniques. CIs on proportions assume binomial distributions. The rule used to define an signals of disproportionate reporting (SDR) is that the lower bound of the central 95% CI on the PRR is >1, and three or more reports have been received naming the relevant product and adverse event.

Documents

Study publications

Alvarez Y, Hidalgo A, Maignen F, Slattery J. Validation of statistical signal d…