Nonclinical Topics

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Nonclinical Study Data Reviewers Guide: This project is to evolve the Nonclinical Study Data Reviewers Guide (SDRG), based on comments from a public PhUSE review, plus adapt to updates of the Technical Conformance Guide, from FDA. Our goal is for the NC SDRG package to be considered in FDA's Intent to Use process in 2016. We also continue 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: Users start with only the implementation guide to use when implementing SEND. Having places to go for new users, (e.g. a forum, Wiki, FAQ, PhUSE website, etc) will substantially help users navigate the pitfalls of implementation. Users will have a clear path to go for assistance with SEND implementation, with the ability to ask questions, receive answers, discuss issues, and learn more about common implementation issues.

Application of SEND Data for Analysis: This Working Group will focus on individual SEND domains in a prioritised manor. Once the scientific questions that will arise during review of SEND data has been identified, SEND domain specific analyses using example analysis keys (i.e. SEND variables) will be proposed to aid in getting the right answers from SEND datasets. Certain SEND variables will lend themselves better to computational analysis by being subject to controlled terminology, formats and/or expectancy requirements by the standard, while other variables are under the control of the sponsor (either with population by need or choice or through sponsor controlled vocabularies). The purpose of the Working Group is to come up with recommendations for which variables that are critical minimum information for any review of the data. Analyses is in this working group context defined as a review of SEND data, not the statistical outcomes of the study.

Visualisation of Group Related Differences in Histopathology Data: To canvas opinion from toxicologist, pathologist, bioinformatics specialists and software designers on current methods of data visualisation and how those might be improved or expanded to improve data analyses compared to currently used tabular (incidence) formats. To communicate points of discussion, ideas, case examples, etc. with key stake holders (the pharmaceutical industry, software developers/vendors, CRO's, US FDA) via the Wiki, poster presentations and publications.

Industry SEND Progress Survey: To create an electronic survey sponsored by PhUSE with up to 15 multiple choice questions with an option to provide additional free text information. Send that survey out to the PhUSE members requesting a 30 day response time. Compile the responses and distribute to PhUSE members and make the results available on the PhUSE Wiki.

Nonclinical Script Assessment Project: 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?

Data Consistency: SEND Datasets and the Study Report: Identify and address inconsistencies between the study report and the SEND datasets. Determine which would be acceptable and which are not. Develop potential solutions for how companies go about fixing the ones that are not deemed acceptable.

Modeling Endpoints: How to Model Anti-Drug Antibody Data in Nonclinical Studies: (New Project) To provide recommendations for modeling Anti-Drug Antibody utilizing SENDIG V3.0 and SENDIG V3.1 domains and variables. To create a landscape of possible solutions and provide recommendations. Consider appropriateness for visualization for ADA at high level. Investigate the current SDTM practices and recommendations.

Demystifying Define-XML Codelist Handling for Nonclinical Studies: (New Project) The goal of this project is to provide recommendations for specific problems/questions encountered when fulfilling the define.xml codelist section for a nonclinical study. The scope will include exploration of published general information (clinical or nonclinical) about implementing code lists in define.xml and relating this to specific challenges expressed by nonclinical data stakeholders, such as: Is there a relationship to operational procedures on the data collected (i.e. glossaries)? What is the appropriate granularity? The project will include exploration for the codelist content of define.xml files associated with SEND datasets and how this is used by FDA as a consumer of the define.xml file. The result of this project is expected to be recommendations to the public on best practices for fulfilling codelist section of the definition.xml for SEND study submissions.


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