WG6 Nonclinical - Historical Controls

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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/Challenge

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?

Vision

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.


Plans

Identified Projects/Pilots/Activities

  1. ID established definitions of historical controls
  2. What are precieved uses/benefits of HC at different levels of aggregations
  3. ID highest priorities of these uses

Milestones

  1. ID established definitions of historical controls - June 2012
  2. What are precieved uses/benefits of HC at different levels of aggregations - September 2012
  3. ID highest priorities of these uses - March 2013


Tasks

Planned

  1. Gather published definitions of HC data or from other sources

Accomplished


Deliverables

March 2012 - March 2013

  • List of prioritized perceived benefits of HC data types and recommendations of next steps.

Participation needs

The following types of stakeholders are encouraged to participate:

  • Pharma - Scientific Staff
  • Vendors - Software and Tech
  • FDA - Pharmacologists, Toxicologists, Statisticians

Communications

  • 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

WG6 DDMONYYY



Last revision by TJKropp,03/23/2012