WG6 Nonclinical - Historical Controls
Nonclinical Historical Control
Welcome to the Wiki for the Nonclinical Historical Control (HC) Project, part of the of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.
Overview & Scope
Need ID 0005 & 0010. A great percentage of the spend for developing a drug goes to the development of control data for each study. Could a cross-functional group develop a whitepaper on historical control database development and use? Including FDA, sponsors, Contract Research Organizations, solution providers. How do the entities use or plan to use historical controls? What are the challenges with the use (and variety of uses)? What is the implication of the increasing number of studies being conducted at Contract Research Organizations, are we all collecting historical controls? How can we use these data to streamline the drug development process? Can we reduce costs of current studies based on historical data or by use of historical data in combination with current study control groups?
A better understanding of the values and challenges of using historical control data. If feasible, then use of historical control data for better study interpretation.
- ID established definitions of historical controls
- What are precieved uses/benefits of HC at different levels of aggregations
- ID highest priorities of these uses
- ID established definitions of historical controls - June 2012
- What are precieved uses/benefits of HC at different levels of aggregations - September 2012
- ID highest priorities of these uses - March 2013
- Gather published definitions of HC data or from other sources
March 2012 - March 2013
- List of prioritized perceived benefits of HC data types and recommendations of next steps.
The following types of stakeholders are encouraged to participate:
- Pharma - Scientific Staff
- Vendors - Software and Tech
- FDA - Pharmacologists, Toxicologists, Statisticians
- Teleconference are held [every two weeks]
- [T-con details]
- Quarterly updates to overall WG.
- Contact [x] with any questions
Work Group Participants
Louis Norton, Covance (co-lead)
Lauren Mihalcik, FDA (co-lead)
Ben Sefing, Merck
Jennifer Feldmann, Instem
Tara Hamilton, Merck
Paul Brown, FDA
Conference Calls and Minutes
Last revision by TJKropp,03/23/2012