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Organon

FDA/PhUSE Annual Computational Science Symposium
Working Group Descriptions


The working groups are listed below. These working groups were developed based on the groups identified at the annual meeting in March of 2011 and have been modified to reflect the most critical needs of both FDA and Industry.

Working Group 1: Data Validation and Quality Assessment
This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through the product life cycle across both industry and regulatory review. The group will discuss current pains and potential solutions around topics such as the current data validation rules as well as the CDISC Data Validation Project, development and implementation of tools, terminology, and improving the quality of the data to support analytical needs.

Working Group 2: Standardizing data within the Inspection Site Selection Process
This working group will focus on continuing the ongoing work developing standards for the data set used in a risk model designed to improve the quality of clinical inspection site selection for drug trials. This working group will discuss ways to incorporate the site selection tool data set variables into existing standards and identify potential standardized methods for both the industry and FDA to develop the data sets in the specified format.

Working Group 3: Challenges of Integrating and Converting Data across Studies
This working group will first discuss the challenges of analyzing and integrating data from retrospective studies from both an industry and regulatory perspective including the conversion of legacy data, effects of different study designs, and how the flexibility in standards leads to issues. The group will then work towards identifying best practices for topics that might include standard protocol design elements, consistent data collection rules, conversion of legacy data, and the application of other standards up front in the data collection process for all future studies, as well as the impact those would have on time, resources, and scope.

Working Group 4: Standards Implementation Issues with the CDISC Data Models
This working group will identify specific challenges with implementing the CDISC data standards on individual study elements including topics such as reviewing the CDER common issues document, a similar issues list which will be provided from CBER, feedback from the legacy data conversion project, and other gaps identified across the review process. This group will prioritize the issues and begin to make recommendations for changes or best practices in using the standards as well as document successful implementation practices for sharing across the FDA and industry.

Working Group 5: Development of Standard Scripts for Analysis and Programming
This working group will identify potential standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set. This will be an interactive session using online wiki to create and add input that can be shared openly between industry and regulatory.

Working Group 6: Non-Clinical Road-map and Impacts on Implementation
This working group will discuss various approaches to the standardization of nonclinical data and the possible implications to the development and implementation of data standards. The group will brainstorm and discuss approaches that may be used to meet the standardization needs for types of data that have no current standardization strategy. This session will help the working group develop a 'road map to the standardization of nonclinical data’ over the course of the next year.