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PhUSE CSS Working Group 2014 Activities

The PhUSE CSS Working Groups bring together academia, industry, technology providers and the FDA to collaborate on projects to address unmet computational science needs. At the 2014 annual PhUSE Computational Science Symposium the following project groups will meet to continue their work from previous years. Additionally, several new projects will be launched at the 2014 meeting!

If you have an idea of a new project, complete the Project Request Form.

Optimizing the Use of Data Standards

The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps and best practices to help FDA and industry optimize the use of standards. CDISC works on the development of standards and PhUSE explores the implementation of those standards.
    •    Analysis Data Reviewer's Guide (ADRG): Continued Development of ADRG Completion Guidelines and ADRG Template - If you have examples of ADRGs, bring them to the CSS!
    •    Traceability and Data Flow: Help finalize two white papers documenting traceability needs for the FDA. One white paper focuses on study-level traceability needs and the other traceability needs for integrated studies.
    •    New Project Coming Soon!


Development of Standard Scripts for Analysis and Programming

With the development and implementation of industry data standards, there is a great opportunity to develop standard reporting across industry and to support the needs of FDA medical and statistical reviewers. This working group will identify potential standard scripts for data transformations and analysis across and within therapeutic areas. 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.
    •    PhUSE Code Repository: Continue process and platform enhancement including identification to the next steps for adding the output from the script-athon to the repository!
    •    White Papers: Continued development of white papers for recommended analysis and displays including feedback review. Please see the PhUSE Wiki for the list of papers in development.
    •    Script-athon: Collaborate with other participants to create standard scripts that will be placed in the PhUSE Code Repository. Targets will be selected from the finalized white paper on analysis and displayed associated with measures of central tendency

Emerging Technologies

Regulatory science and drug, biologic and new device development challenges present a unique opportunity to apply under utilized existing technologies and/or new and emerging technologies. This working group, launched at the 2013 annual PhUSE CSS, provides an open, transparent, pre-competitive forum for the exploration and application of said technologies to address these challenges. If you have an interesting challenge in need of an innovative solution, submit a New Project Request today!

    •    Semantic Technology, Representing CDISC Protocol Representation Model (PRM) in RDF: Do you want your protocol available in a machine-processable format? Come join the team as they continue their work representing the PRM and Study/Trial Design Model in RDF. The team is currently focused on representing the schedue of events and activities and will be moving onto eligibility and experimental design.
    •    (NEW) Semantic Technology, Representing Analysis Results Metadata in RDF: Begin work on the development of standard models and technical standards for the storage and usage of analysis results data and metadata to support clinical and non-clinical applications.
    •    Semantic Technology, New Project Coming Soon!
    •    Common Metadata Definitions and a Practical Metadata Management Implementation Guide: Finalize the metadata definitions document and evaluate the needs and the other traceability needs for integrated studies.
    •    Lowering Barriers to Adoption of Cloud Technology

Non-Clinical Road-map and Impacts on Implementation

There is a need to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and then establishing an innovative framework for addressing them in a collaborative manner. The group created a framework for moving certain projects forward to support nonclinical informatics efforts and to develop specific implementation solutions for SEND.
    •    Nonclinical Data Interconnectivity
    •    Interorganizational SEND
    •    SEND Implementation User Group