Data Visualisation & Open Source Technology – Project Volunteer Board
Welcome! |
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Interested in joining one of the Data Visualisation & Open Source Technology Working Group Projects? The projects below welcome new volunteers. |
Project Scope: Development of an open-source tool and package to enable generation of identified interactive plots for clinical review and direct inclusion in submissions to regulatory agencies. The initial scope is to develop a package to generate interactive forest and volcano plots for adverse events and FDA Medical Queries (FMQs) analysis outputs for inclusion in submissions to the FDA. This work is a collaboration among the American Statistical Association (ASA), PHUSE and the FDA. | Regular Project Meeting Day/Time:
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Project Scope: Comparing Analysis Method Implementations in Software (CAMIS) has evolved from the Clinical Statistical Reporting in a Multilingual World project. Several discrepancies have been discovered in statistical analysis results between different programming languages, even in fully qualified statistical computing environments. Subtle differences exist between the fundamental approaches implemented by each language, yielding differences in results which are each correct in their own right. The fact that these differences exist causes unease on the behalf of sponsor companies when submitting to a regulatory agency, as it is uncertain if the agency will view these differences as problematic. Understanding the agency’s expectations will contribute significantly to enabling the broader adoption of multiple programming languages in the production of data submission packages for regulatory review The CAMIS project seeks to clearly define this problem and provide a framework for assessing the fundamental differences for a particular statistical analysis across languages. In this context, the risk of interpreting numerical differences in analysis results due solely to differences in programming language can be mitigated, instilling confidence in both the sponsor company and the agency during the review period. This will be accomplished by:
The CAMIS repository to document known differences is now live and open for community contributions. | Regular Project Meeting Day/Time:
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Project Scope: Research: Conduct a detailed analysis of the current teal framework and identify areas where flexibility can be introduced. A Proof-of-Concept will be provided after research. Development: Development: Design and implement new functionalities to address the gaps and opportunities identified during the research phase, enhancing the framework's adaptability. Testing: Develop test cases to ensure the new functionalities are compatible with existing modules and meet the customisation needs of different companies. Documentation: Update the framework's documentation to include instructions on how to use the new features. Training & Support: Provide training and ongoing support to users within the pharma industry to facilitate the adoption of the enhanced teal framework. | Regular Project Meeting Day/Time:
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Project Scope: The PHUSE project team will extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied. | Regular Project Meeting Day/Time:
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Project Scope: This project aims to develop a new template or enhance an existing one such as the Study Data Standardization Plan (SDSP) or Analysis Data Reviewer’s Guide (ADRG), to ensure that metadata pertaining to the versions of statistical packages and procedures is consistently documented in alignment with health authority expectations. This standardized template will streamline the submission of clinical study metadata to health authorities as part of the regulatory review process. | Regular Project Meeting Day/Time:
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