Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports.

ABSTRACT:

Background

The Cochrane risk of bias tool is a prominent instrument used to evaluate potential biases in clinical trials. In three updates of our Cochrane review on neuraminidase inhibitors, we assessed risk of bias on the same trials using different levels of detail: the trials in journal publications, in core reports, and in full clinical study reports. Here we analyse whether progressively greater amounts of information and detail in full clinical study reports (including trial protocols, statistical analysis plans, certificates of analyses, individual participant data listings and randomisation lists) affected our risk of bias assessments.

Methods and findings

We used the Cochrane risk of bias tool to assess and compare risk of bias in 14 oseltamivir trials (reported in

SUBMITTER: Jefferson T 

PROVIDER: S-EPMC4179405 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature