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

Basic Details
Date Posted
Status
Complete
Medical Product
lamotrigine
levetiracetam
Health Outcome(s)
Multi-Level Clinical Classification Software (MLCCS) outcome tree
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. 

Deliverable(s) (1)
Evaluation of Three Self-Controlled Methods for Signal Detection: TreeScan, Sequence Symmetry Analysis, and Information Component Temporal Pattern Discovery 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 Member(s)

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