Community Opinions on the Collection and Use of Historical Control Data in Nonclinical Toxicity Studies

Abstract

Background:

Access and use of historical control data was identified as a top stakeholder concern across organizations according to results of a survey of needs and challenges related to nonclinical data conducted by the FDA/PhUSE Nonclinical Working Group in 2011. There is a perception there may be additional ways to capitalize on historical control data to enhance studies or submissions across industry, academia, and government. During the working sessions of the FDA/PhUSE Computational Sciences Symposium in March 2012, a Historical Control subgroup of the FDA/PhUSE Nonclinical Working Group was formed to investigate how the industry might more effectively harness the vast amount of data from untreated/vehicle control animals. The subgroup includes broad representation of stakeholders with interest in nonclinical data.

Methods:

This paper describes progress to date and includes results of a second survey to determine how organizations use and would like to use historical control data.

Results:

Respondents to the survey strongly support that historical control data are useful and should be in an accessible format. Four potential project options were posed in the survey, with an overall positive response; also, several write-in options were suggested by respondents.

Conclusions:

Community-supported projects to increase the availability of well-annotated and scientifically curated collections of historical control data appear to be of most interest.