Nonclinical Topics

Working Group & Project Scope

Working Group Leads

Sue DeHaven

Patty Brundage

Our focus is on using informatic approaches and standards for delivering ideas and solutions to nonclinical data challenges. The Nonclinical Topics Working Group aims to improve nonclinical assessments and regulatory science by identifying key needs and challenges in the field and to establish an innovative framework for addressing them in a collaborative manner through limited-term projects.

Data Consistency: SEND Datasets and the Study Report

Fred Wood

Maria Francomacaro

This project identifies and addresses inconsistencies between the study report and the SEND datasets, with the aim of determining which are acceptable and which are not. The project seeks to develop potential solutions for companies to fix those that are not deemed acceptable.

Industry SEND Progress Survey 

Bob Friedman

Lou Ann Kramer

This project creates an electronic survey sponsored by PhUSE, with up to 15 multiple choice questions and an option to provide additional free text information. The survey is sent out to PhUSE members, requesting a 30-day response time, then the responses are compiled and distributed to PhUSE members and the results made available on the PhUSE Wiki.

Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies

Michael Wasko

Gretchen Dean

The goal of this project is to provide recommendations for modeling anti-drug antibody data utilising SENDIG v3.0 and SENDIG v3.1 domains and variables; to create a landscape of possible solutions and provide recommendations; to consider appropriateness for visualisation for ADA at a high level; and to investigate the current SDTM practices and recommendations.

Nonclinical Script Assessment 

William Houser

Kevin Snyder

Analysis scripts for SEND data would be valuable tools. Can existing clinical scripts be used to help develop nonclinical scripts? What is the best process for prioritising, developing and releasing analysis scripts for SEND data?

Nonclinical Study Data Reviewer's Guide

Sue DeHaven

Debra Oetzman

This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PhUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.

SEND Implementation User Group 

Troy Smyrnios

Debra Oetzman

New users implementing SEND start out with only the implementation guide as a resource. Having additional places to turn to for assistance (e.g. forums, the Wiki, FAQ and the PhUSE website) substantially helps new users navigate the pitfalls of SEND implementation, offering them the opportunity to ask questions, receive answers and to discuss and learn more about common implementation issues.

SEND Dataset QC Best Practices 

Jesse Anderson 

Michael Rosentreter

Across industry, there are a wide variety of quality control (QC) checks for SEND datasets. This is currently done without commonly acknowledged scope and intensity, based on the companies own approaches. For more confidentiality of the quality of SEND dataset across different stakeholders this group targets to:

  • Explore the variety of QC procedures and tools among different stakeholders
  • Identify practical amount of QC checking of SEND datasets (including the QC checks for the comparison of SEND datasets and the study report)
  • Identify a suite of tools and procedures (e.g. visualization, documentation, etc) for QC
  • Develop recommendations for stakeholders for efficient and effective SEND QC practices and, in the long term, for starting a foundation of commonly agreed QC procedures

 

 

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