Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery

Project Title Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery
Date Posted
Wednesday, April 24, 2019
Status
In progress
Deliverables
Description

The aim of this methods project is to compare the relative performance of three analytic methods, TreeScan, Sequence Symmetry Analysis (SSA), and Information Component Temporal Pattern Discovery (ICTPD) in signal detection capability (both type I and type II error) using a simulated dataset as well as concordance in alerting when using an empiric dataset. The Workgroup will use the same dataset(s) to examine health outcomes of interest using all three methods.

The Workgroup will select at least one drug evaluation example with a well-known safety profile for evaluation of TreeScan, SSA, and ICTPD.

For the primary analysis the Workgroup will use the CDER-curated Multi-Level Clinical Classification Software (MLCCS) outcome tree. This tree contains thousands of hierarchically grouped adverse events based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes.  For the secondary analysis the Workgroup will scan the same outcomes defined by a single ICD-9-CM diagnosis code, i.e. absent any clinically related groupings. 

This protocol was posted for public comment from November 30, 2018 through December 28, 2018. A log of changes is included in the revised protocol. 

Workgroup Leader(s)

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

Shirley V. Wang PhD, ScM; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

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

Workgroup Members

Elande Baro PhD; Sai Dharmarajan PhD;  Office of Biostatistics, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

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

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

Esther Zhou MD, PhD; Office of Pharmcovigilance and Epidemiology, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD

Joshua J. Gagne PharmD, ScD; Sushama Kattinakere MBBS, MSPH: Martin Kulldorff PhD; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA

David Cole BM, Inna Dashevsky MS; Sandra DeLuccia MPH; Aaron Hansbury MPH; Ella Pestine MPH; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

Jesper Hallas MD, DrMedSc; Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense, Denmark

Niklas Noren PhD; PhD, MSc, Uppsala Monitoring Centre, Uppsala, Sweden

Medical Product
lamotrigine
levetiracetam
Health Outcome
Multi-Level Clinical Classification Software (MLCCS) outcome tree