Are Phase 3 Clinical Trials Really Becoming More Complex?

Background: This study uses the data from many of the mandatory fields in ClinicalTrials.gov to examine changes, possibly leading to more complexity in the design and execution of commercially sponsored phase 3 clinical trials.

Methods: In this analysis we compare baseline year 2008 data, when a broad number of the protocol/study design and execution variables became mandatory, with the data from the last full year of results, 2013.

ClinicalTrials.gov: An Underutilized Source of Research Data About the Design and Conduct of Commercial Clinical Trials.

Since 2007, the US federal government has required that organizations sponsoring clinical trials with a least one site in the United States submit information on these clinical trials to an existing database: ClinicalTrials.gov . Over time, the number of mandatory variables has grown and will probably continue to grow.