Modernization of Statistical Analytics Solutions

The resources below were developed by the Modernization of Statistical Analytics (MoA) Initiative in an effort to accelerate the use of novel statistical computing capabilities when engaging with Health Authorities.

ART Model

THREE CORE PRINCIPLES FOR REGULATORY COMPLIANCE & IMPLEMENTATION SUCCESS

Reproducibility REPRODUCIBILITY If a statistical analysis output can be recreated from the original dataset along with the associated environment, including all artifacts and dependencies, it is reproducible. If an output is not reproducible, it is questionable whether results of the output can be trusted. Traceability TRACEABILITY Refers to the ability to trace inputs to outputs, with the main goal being to provide evidence to connect e-data, code, and environment to the final output that is produced. Accuracy ACCURACY The measure of correctness of software libraries that are used to generate results from an MSA environment – it is not the programs that developers write using those software libraries.

Accuracy

The measure of correctness of software libraries that are used to generate results from an MSA environment – it is not the programs that developers write using those software libraries.

Traceability

Refers to the ability to trace inputs to outputs, with the main goal being to provide evidence to connect e-data, code, and environment to the final output that is produced.

Reproducibility

If a statistical analysis output can be recreated from the original dataset along with the associated environment, including all artifacts and dependencies, it is reproducible. If an output is not reproducible, it is questionable whether results of the output can be trusted.

Modernization of Statistical Analytics (MSA) Framework

This Framework is based upon a methodology that establishes the principles of accuracy, reproducibility, and traceability for a modern analytical software environment to demonstrate that the results it generates is reliable. A set of best practices and guiding principles is also provided to support the Framework’s implementation across industry sponsors and other stakeholders. Click here to download. 

Modernization of Statistical Analytics (MSA) Infographic

Provides a visual overview of the MSA Framework including key methodologies, concepts, and impact areas for a broader understanding of the Framework paper. Click here to download.

Case for Adoption

A presentation to support the socialization and usage of the framework concepts. This deck aims to help organizations better understand and utilize the MSA Framework as they explore the use of nontraditional analytical software in clinical research. Click here to download.

Modernization of Statistical Analytics Case Study Video Library

Each presentation guides the viewer through a case study scenario that focuses on how the framework was applied in that implementation example and the lessons learned around the benefits, challenges and efficiencies during the implementation process.

Asset TypeTitle DescriptionPhase of Framework Implementation
Case Study 1: Interactive Collection of Analysis ToolsA collection of interactive and static analysis tools enabling faster and more efficient exploratory analysis and regulatory delivery of clinical trials insights.Production – Coming Soon
Case Study 2: Environment for Regulatory Submission
(Video & Presentation)
Multi-server computational environment that contains two different types of open source installations – usual installations for exploratory and general work and frozen installations for submission related work.Production
(Note: with ongoing loops between design and implementation with platform evolution)
Case Study 3: Group Sequential Design
(Video & Presentation)
Study design for group sequential studies to expand and enable the universe of ‘increasingly compliant’ tools with increasing capabilities.Production
(Note: with ongoing loops between design and implementation with platform evolution)
Case Study 4: Testing/Verification
(Video & Presentation)
Offers guidance on providing a secure and reliable environment for both exploratory and submission related analyses using open-source products.Production
Case Study 5: Implementation and Validation Concept
(Video & Presentation)
Explains digital transformation requirements for integrating reports into standard reporting system to create transparency.Pre-Planning
Case Study 6: Using the Framework to Improve Package Validation Process Lessons learned during building a process to use suitable digital solutions for Digital transformation and integrability, Data analysis and Reporting.Production – Coming Soon
*Note: TransCelerate does not endorse the use of any particular software.