From Protocols to Publications: A Study in Selective Reporting of Outcomes in Randomized Trials in Oncology.

ABSTRACT:

Purpose

The decision by journals to append protocols to published reports of randomized trials was a landmark event in clinical trial reporting. However, limited information is available on how this initiative effected transparency and selective reporting of clinical trial data.

Methods

We analyzed 74 oncology-based randomized trials published in Journal of Clinical Oncology, the New England Journal of Medicine, and The Lancet in 2012. To ascertain integrity of reporting, we compared published reports with their respective appended protocols with regard to primary end points, nonprimary end points, unplanned end points, and unplanned analyses.

Results

A total of 86 primary end points were reported in 74 randomized trials; nine trials had greater than one primary end p

SUBMITTER: Raghav KP 

PROVIDER: S-EPMC4979242 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature