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Likelihood ratio based tests for longitudinal drug safety data.

Lan Huang1, Jyoti Zalkikar, Ram Tiwari

  • 1Division of Biometrics V, Office of Biostatistics, OTS, CDER, FDA, Silver Spring, MD 20993, U.S.A.

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|June 13, 2014
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Summary
This summary is machine-generated.

New statistical methods, longitudinal likelihood ratio tests (LongLRT), suggest proton pump inhibitors (PPIs) may increase adverse events in osteoporosis patients. These methods offer reliable safety surveillance for large datasets.

Keywords:
active surveillancedrug exposurelongitudinal methodsafety surveillancesequential method

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Area of Science:

  • Biostatistics
  • Pharmacovigilance
  • Clinical Trial Methodology

Background:

  • Large longitudinal databases are crucial for drug safety surveillance.
  • Evaluating adverse events in clinical trials requires robust statistical methods.
  • Concomitant use of proton pump inhibitors (PPIs) with osteoporosis drugs warrants safety investigation.

Purpose of the Study:

  • To introduce and evaluate novel longitudinal likelihood ratio test (LongLRT) methods for analyzing large datasets.
  • To assess the potential association between PPI use and adverse events in osteoporosis patients.
  • To present a special case, sequential LRT (SeqLRT), for evaluating specific drug safety signals.

Main Methods:

  • Development and application of longitudinal likelihood ratio test (LongLRT) methods.
  • Utilizing a pooled longitudinal clinical trial dataset for osteoporosis drugs and PPIs.
  • Employing simulated datasets to evaluate method performance (power, type I error control).

Main Results:

  • LongLRT and SeqLRT methods demonstrated good performance in simulations regarding power and type I error control.
  • Preliminary analysis indicated possible evidence linking concomitant PPI use to increased adverse events in osteoporosis patients.
  • The proposed methods are applicable to large observational databases, including the FDA Sentinel Initiative.

Conclusions:

  • The developed LongLRT and SeqLRT methods are effective for safety surveillance in large longitudinal datasets.
  • Further investigation is warranted regarding the association between PPIs and adverse events in osteoporosis treatment.
  • These statistical approaches enhance the capability for active surveillance of drug safety.