The Nonclinical Historical Control (HC) Project is part of the of the FDA/PHUSE Computational Sciences Nonclinical Working Group. We gathered interested participants from industry, academia, and governmental organizations to identify the most promising projects related to historical control data at various levels of aggregation. With the rise of electronic nonclinical datasets, is it time to consider how we might more effectively harness decades of untreated control data? The kinds of questions were considered included:
|The Working Group drafted a survey covering various aspects of nonclinical historical control data and distributed it to a wide variety of stakeholder groups. There were 352 respondents. Results were presented in a poster at the 2014 FDA/PHUSE Computational Science Symposium in Silver Spring, Maryland. The paper describing the survey and its results has been accepted for publication.|
During a broad survey of needs and challenges related to nonclinical data, issues related to historical control data were a top concern of stakeholders across organizations. There is a perception that there may be additional ways to make further use of historical control data to enhance studies or submissions across industry, academia, and government.
During the working sessions of the FDA/PHUSE Computational Sciences Symposium, participants discussed options for identifying the highest priority projects in this area. There was agreement that the idea of "historical control data" had several connotations which should be clarified prior to proceeding with this project.
Develop recommendations for high priority projects regarding the use of historical control data. These recommendations could include identification of areas where additional aggregation or analysis of historical control data may be useful or identification of data standards to develop and pilot for exchange of historical data.