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Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot.
Pharmacoepidemiol Drug Saf. 2012 Jan; 21 Suppl 1:72-81.PD

Abstract

PURPOSE

This manuscript describes the current statistical methodology available for active postmarket surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data.

METHODS

Motivation of the active postmarket surveillance setting is provided using the Food and Drug Administration's Mini-Sentinel Pilot as an example. Four sequential monitoring statistical methods are presented including the Lan-Demets error spending approach, a matched likelihood ratio test statistic approach with the binomial MaxSPRT as a special case, the conditional sequential sampling procedure with stratification, and a generalized estimating equation regression approach using permutation. Information on the assumptions, limitations, and advantages of each approach is provided, including how each method defines sequential monitoring boundaries, what test statistic is used, and how robust it is to settings of rare events or frequent testing.

RESULTS

A hypothetical example of how the approaches could be applied to data comparing a medical product of interest, drug A, to a concurrent control drug, drug B, is presented including providing the type of information one would have available for monitoring such drugs.

Authors+Show Affiliations

Biostatistics Unit, Group Health Research Institute, Seattle, WA 98101, USA. cook.aj@ghc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

22262595

Citation

Cook, Andrea J., et al. "Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for Use in the Mini-Sentinel Pilot." Pharmacoepidemiology and Drug Safety, vol. 21 Suppl 1, 2012, pp. 72-81.
Cook AJ, Tiwari RC, Wellman RD, et al. Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:72-81.
Cook, A. J., Tiwari, R. C., Wellman, R. D., Heckbert, S. R., Li, L., Heagerty, P., Marsh, T., & Nelson, J. C. (2012). Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. Pharmacoepidemiology and Drug Safety, 21 Suppl 1, 72-81. https://doi.org/10.1002/pds.2320
Cook AJ, et al. Statistical Approaches to Group Sequential Monitoring of Postmarket Safety Surveillance Data: Current State of the Art for Use in the Mini-Sentinel Pilot. Pharmacoepidemiol Drug Saf. 2012;21 Suppl 1:72-81. PubMed PMID: 22262595.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Statistical approaches to group sequential monitoring of postmarket safety surveillance data: current state of the art for use in the Mini-Sentinel pilot. AU - Cook,Andrea J, AU - Tiwari,Ram C, AU - Wellman,Robert D, AU - Heckbert,Susan R, AU - Li,Lingling, AU - Heagerty,Patrick, AU - Marsh,Tracey, AU - Nelson,Jennifer C, PY - 2012/1/21/entrez PY - 2012/1/25/pubmed PY - 2012/5/10/medline SP - 72 EP - 81 JF - Pharmacoepidemiology and drug safety JO - Pharmacoepidemiol Drug Saf VL - 21 Suppl 1 N2 - PURPOSE: This manuscript describes the current statistical methodology available for active postmarket surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data. METHODS: Motivation of the active postmarket surveillance setting is provided using the Food and Drug Administration's Mini-Sentinel Pilot as an example. Four sequential monitoring statistical methods are presented including the Lan-Demets error spending approach, a matched likelihood ratio test statistic approach with the binomial MaxSPRT as a special case, the conditional sequential sampling procedure with stratification, and a generalized estimating equation regression approach using permutation. Information on the assumptions, limitations, and advantages of each approach is provided, including how each method defines sequential monitoring boundaries, what test statistic is used, and how robust it is to settings of rare events or frequent testing. RESULTS: A hypothetical example of how the approaches could be applied to data comparing a medical product of interest, drug A, to a concurrent control drug, drug B, is presented including providing the type of information one would have available for monitoring such drugs. SN - 1099-1557 UR - https://www.unboundmedicine.com/medline/citation/22262595/Statistical_approaches_to_group_sequential_monitoring_of_postmarket_safety_surveillance_data:_current_state_of_the_art_for_use_in_the_Mini_Sentinel_pilot_ L2 - https://doi.org/10.1002/pds.2320 DB - PRIME DP - Unbound Medicine ER -