Abstract

In a study designed to establish the safety of a marketed drug, interim analyses performed to detect harm can protect trial participants and the wider public before the final analysis occurs. Monitoring for harm within a safety study is different from monitoring for benefit, so techniques commonly used in an efficacy study of an experimental drug may not apply. We propose potentially more suitable techniques in this setting, including a novel spending function and conditional power. These techniques have reasonable operating characteristics in a simulation. The appropriate technique to implement will depend on circumstances of specific to the individual safety study.

Links

Publisher Full Text

Authors

Fleishman AN, Parker RA

Institution

Amgen, Thousand Oaks, California 91320, USA. alexf@amgen.com

Source

Journal of biopharmaceutical statistics 22:2 2012 pg 338-50

MeSH

Clinical Trials Data Monitoring Committees
Clinical Trials as Topic
Computer Simulation
Data Interpretation, Statistical
Drug Toxicity
Endpoint Determination
Humans
Models, Statistical
Practice Guidelines as Topic
Research Design
Treatment Outcome

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22251178