I’m pleased to share that the R Validation Hub’s efforts have been recognised in the ASA Biopharmaceutical report, Fall 2022. Within the edition you can find our paper, Risk Assessment of R Packages: Learnings and Reflections. This paper reflects on our white paper; provides an overview of our {riskmetric} package and Risk Assessment application; and summarises our 2022 case studies (which you can now find on our Case Studies page).
TransCelerate has published “Modernization of statistical analytics (MSA) Framework”. With goals similar to the R Validation Hub, the TransCelerate MSA framework seeks to demonstrate software reliability by establishing principles of accuracy, traceability, and reproducibility for a modern analytical software environment. The MSA framework is centered around risk-assessment and mitigation practices to demonstrate reliability of software. This framework suggests assessing the accuracy of a software library via a confidence measure built on risk metrics such as published source code, issue management, usage, maturity, etc.
We have reached a major milestone. The R package riskmetric has been released and is now available on CRAN. What is riskmetric? riskmetric is a collection of risk metrics to evaluate the quality of R packages following the framework suggested by the R validation hub (see our white paper for details). Various quality metrics are provided which evaluate best practices of software development, code documentation, community engagement and development sustainability.
The new year is starting with some good news for the R validation hub. We will be able to present our work at a number of different meetings in 2021: National Institute of Statistical Sciences (NISS; April 21, 2021): NISS-Merck Meet-Up on Open Source Software in Pharma Annual Meeting of Statisticians in the Pharmaceutical Industry (PSI; June 21-23, 2021): Contributed session accepted Joint Statistical Meetings (JSM; August 7-12, 2021): Topic-contributed session accepted
2020 was a busy year for the R Validation Hub. We released our white paper describing our current thinking on a risk based approach to using R for regulatory work. We started to support the implementation of the white paper with tools such as riskmetric and our risk assessment application. And we started a new sub-team with the aim of producing a follow-up white paper on testing. Throughout, we have continued to share and gain feedback on our proposed approach, presenting at User!
Background Towards the end of 2019, the R Validation Hub received an additional grant from the R Consortium to progress the next phase of our road map and produce a risk assessment app to complement the riskmetric package. In early 2020, Fission Labs were selected as our partner to build the first iteration of the application. Fission Labs is a software product development services company delivering product life-cycle management and high-end scalable technology solutions.
In this article I summarise some of the key themes from the R Validation Hub’s white paper, A Risk-based Approach for Assessing R package Accuracy within a Validated Infrastructure. What is the R Validation Hub? The R Validation Hub is a cross-industry initiative whose mission is to enable the use of R by the Bio-Pharmaceutical Industry in a regulatory setting, where the output may be used in submissions to regulatory agencies.
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