Jul 2, 2015

Why clinical trials are terminated

BioRxiv : the Preprint Server for Biology
Theodore R. PakFrederick P. Roth

Abstract

Background: Evidence-based clinical practice relies on unbiased reporting of negative results. Meta-analysis of drug safety and efficacy across many clinical trials is difficult given the unconstrained nature of reasons that are provided to ClinicalTrials.gov to explain clinical trial terminations. Methods and Findings: We scanned all trials in ClinicalTrials.gov marked with the “terminated” status (N=3122), meaning the trial had been stopped before the scheduled end date. Under the current reporting framework, any number of reasons may be given for termination, and these need not conform to a controlled vocabulary. Here we develop a controlled vocabulary for trial termination, and map each terminated trial to as many as three vocabulary terms. Mapping to this “ontology of termination” allows further analysis and conclusions. First, we identify the subset of terminated trials that ended citing safety concerns (6.2%) or failure to establish efficacy (10.8%), and were further able to stratify these rates across trials of different phases. Second, we examine termination reasons where a stricter data model could have preserved more evidentiary value, either because the data model was misused (7.6%) or because the given reason left ...Continue Reading

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Mentioned in this Paper

Meta-Analysis (Publications)
Meta Analysis (Statistical Procedure)
Biologic Preservation
Clinical Trials
Analysis
Clinical Trial [Publication Type]
Patient Safety
Scanning
Decision

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