Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry-sponsored trials in off-label uses of gabapentin.

ABSTRACT:

Background

Details about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation.

Methods and findings

For each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One aut

SUBMITTER: Vedula SS 

PROVIDER: S-EPMC3558476 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature