Industry Guidance Design and Conduct of Pregnancy Registries.PPTVIP

Industry Guidance: Pregnancy Registries Industry Guidance: Pregnancy Registries Guidance for Industry Establishing Pregnancy Registries Pregnancy Registry Working Group Pregnancy Labeling Taskforce March, 2000 Evelyn M. Rodriguez M.D., M.P.H. OPDRA, CDER, FDA Outline Why A Guidance Document? What is a pregnancy registry? Purpose of a pregnancy registry protocol. Registry study design. Recruitment Reporting source Follow-up Comparison groups Data analysis Reporting results Why a Pregnancy Registry Guidance Document? To provide useful data to health care providers in caring for their patients What is a Pregnancy Registry? Could have many designs Often hypothesis generating Hypothesis testing Design depends on the hypothesis and outcomes of concern Ideally, prospective enrollment of subjects Actively collects information for providing scientifically based outcome data What is the Purpose of a Pregnancy Registry? Determine risks associated with drug use during pregnancy Measurement of this risk Determine risk factors associated for adverse outcome Could provide margins of reassurance regarding lack of risk Limitations of Current Data Sources Population-based surveillance systems - no linkage of maternal exposures and fetal outcome is available Spontaneous Reports - bias in reporting and no incidence estimate available Clinical Trials - Lack of meaningful data What is the Purpose of aPregnancy Registry Protocol? To assure quality validity of data elements collected To assure documentation and consistency of research methods What are Pregnancy Registries? Observational (non-experimental) studies that actively enroll subjects Registration is ideally prospective Early in pregnancy Drug exposure prior to or during pregnancy What are Pregnancy Registries? (continued) Determine rates of outcome among mothers exposed to drug Comparison Groups Known background population rates Concurrently enrolled unexposed mothers with or without underlying disease of interest