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TreeScan in Pregnancy

Basic Details
Date Posted
Wednesday, July 14, 2021
Status
In progress
Health Outcome(s)
infant outcomes
maternal outcomes
Description

The goals of this methods project are to evaluate the performance of TreeScan to assess maternal and infant outcomes, test signal identification methods in a pregnancy setting, and evaluate methods performance using older drugs with relatively well-characterized safety profiles.

A Propensity Score-Based TreeScan approach will be the primary analysis for this project. There will be two analyses: 1) empirical (real) data set and a 2) simulated data set with investigator-inserted risks. Two protocols will be written for Aims 2 and 3, respectively, and posted for public comment.

Aim 1:

  • a) Develop a mother-infant linkage programming module, to be executed in Merative™ MarketScan® Research Databases, that produces an SCDM-compliant mother-infant linkage table using a published method.
  • b) Develop a general propensity score for pregnant women.
  • c) Develop tree of infant outcomes in ICD-10-CM and develop tree of maternal outcomes in ICD-10-CM.  

Aim 2:

  • a) Assess the performance of TreeScan to detect infant outcomes using empirical data with the following outcomes: congenital malformations as the primary objective and a selection of additional outcomes including small for gestation age, low birth weight, and increased rate of premature birth as the secondary objectives.
  • b) Perform a simulation study with investigator-injected risks to develop data on the power to detect risk under ideal circumstances, using empirical data to develop background rates. 

Aim 3:

  • a) Assess the performance of TreeScan to detect maternal outcomes using empirical data among pregnant women with live birth outcomes.
  • b) Perform a simulation study with investigator-injected risks to develop data on the power to detect risk under ideal circumstances, using empirical data to develop background rates.

This infant outcomes protocol was posted for public comment from June 19, 2020 through July 6, 2020. The public comment period is now closed. A revised version was approved for implementation by FDA on August 17, 2020. A second revised version was approved for implementation by FDA on February 9, 2021. A log of changes is included in the revised protocol (v3).

This maternal outcomes protocol was posted for public comment from June 29, 2021 through July 13, 2021. The public comment period is now closed. A revised version was approved for implementation by FDA on August 17, 2022. A log of changes is included in the revised protocol (v2).

Deliverable(s) (7)
Use of the Tree-Based Scan Statistic for Surveillance of Maternal Outcomes Following Medication Use During Gestation: Protocol Use of the Tree-Based Scan Statistic for Surveillance of Maternal Outcomes Following Medication Use During Gestation: Appendices Use of the Tree-Based Scan Statistic for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: Protocol Use of the Tree-Based Scan Statistic for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: Appendices Sentinel Modular Program Report: Use of the Tree-Based Scan Statistic for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use Sentinel Modular Program Report: Use of the Tree-Based Scan Statistic for Surveillance of Maternal Outcomes Following Medication Use During Gestation: Active Comparator Analysis Sentinel Modular Program Report: Use of the Tree-Based Scan Statistic for Surveillance of Maternal Outcomes Following Medication Use During Gestation: Unexposed Comparator Analysis
Information
Population / Cohort
Mothers, infants
Data Source(s)
Merative™ MarketScan® Research Databases
Related Links
Related Link(s)
Publication: Novel Methods for Pregnancy Drug Safety Surveillance in the FDA Sentinel System
Presentation: Design Considerations for Using the Tree-based Scan Statistic in Surveillance of Maternal Outcomes Following Medication Use during Gestation
Presentation: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics
Presentation: Using TreeScan as a Signal Identification Approach to Screen for Adverse Maternal Outcomes of Medication Use in Pregnancy
Presentation: Statistical Power for Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use
Presentation: Use of Tree-Based Scan Statistics for Surveillance of Infant Outcomes Following Maternal Perinatal Medication Use: A Propensity Score Matched Case Study
Presentation: CNODES Webinar: Surveillance of Adverse Infant Outcomes Following Maternal Medication Use During Pregnancy Using Tree-Based Scan Statistics
Publication: Monitoring Drug Safety in Pregnancy with Scan Statistics: A Comparison of Two Study Designs
Workgroup Leader(s)

Judith C. Maro, PhD, Elizabeth Suarez, PhD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Danijela Stojanovic, PharmD, PhD; Office of Surveillance and Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Workgroup Member(s)

David Cole; Inna Dashevsky, MS; Sandra DeLuccia, MPH; Talia Menzin, MS; Jennifer Noble; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Thuy N. Thai, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL

Almut G. Winterstein, PhD, Department of Pharmaceutical Outcomes and Policy, College of Pharmacy; Center for Drug Evaluation and Safety; Department of Epidemiology, College of Medicine and College of Public Health and Health Professions, University of Florida, Gainesville, FL

Monica Munoz, PharmD, PhD; Division of Pharmacovigilance, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Michael Nguyen, MD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 

Abby Anderson, MD; Division of Bone, Reproductive, and Urologic Products, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD 

Steven Bird, PharmD, PhD; Division of Epidemiology, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Yueqin Zho, PhD; Di Zhang, PhD; Office of Biostatistics, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Jane Liedtka, MD; Division of Pediatric and Maternal Health, Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD

Wei Liu, PhD; Center for Drug and Evaluation Research, US Food and Drug Administration, Silver Spring, MD