Optimizing collection of adverse event data in cancer clinical trials supporting supplemental indications.

ABSTRACT:

Purpose

Although much is known about the safety of an anticancer agent at the time of initial marketing approval, sponsors customarily collect comprehensive safety data for studies that support supplemental indications. This adds significant cost and complexity to the study but may not provide useful new information. The main purpose of this analysis was to assess the amount of safety and concomitant medication data collected to determine a more optimal approach in the collection of these data when used in support of supplemental applications.

Methods

Following a prospectively developed statistical analysis plan, we reanalyzed safety data from eight previously completed prospective randomized trials.

Results

A total of 107,884 adverse events and 136,608 concomitant me

SUBMITTER: Kaiser LD 

PROVIDER: S-EPMC3018355 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature