PS48: From Comparison to Confidence: Achieving First-Pass Milestone of CAMIS Project and Sustaining Open-Source Validation

As the biopharmaceutical industry increasingly adopts open-source languages, the primary hurdle remains the objective "equivalence" of statistical results produced using SAS® procedures and relevant R packages. The CAMIS (Comparing Analysis Method Implementations in Software) project was launched to demystify these discrepancies by providing a rigorous, side-by-side technical map of statistical outputs. This session marks a milestone: a first-pass completion of the initial CAMIS project objective. We will detail the final findings of the cross-platform comparisons, highlighting where differences are purely syntactical versus where they stem from underlying algorithmic defaults (e.g., tie-handling in survival analysis or rounding rules). However, completion is not the end-state. The open-source ecosystem is dynamic, with packages evolving more rapidly than proprietary software. To address this, the session introduces a sustainable "Day 2" strategy and thoughts. We will demonstrate how the foundational knowledge from CAMIS is operationalized through a continuous validation framework. This ensures that as R packages are updated, the industry maintains a "living library" of GxP-ready tools without duplicating the Herculean effort of the initial CAMIS research. By bringing together perspective from the FDA, Academia, and Industry, this session provides a roadmap for moving beyond "dual programming" toward a future of confident, R-native regulatory submissions. PROPOSED PARTICIPANTS: | Chair | Atorus Research | Introduction: The Evolution of the Open-Source Trust Framework | | Speaker 1 (Industry) | CAMIS Lead/Working Group | The Final Map: Results and Lessons from the CAMIS Project Completion | | Speaker 2 (Regulatory) | FDA | A Regulatory Lens on Open-Source Software: Expectations for Comparability and Validation | | Speaker 3 (Academic) | University Statistics Dept | Ensuring Algorithmic Integrity: The Importance of Open-Source Peer Review in Clinical Stats | | Speaker 4 (Industry) | Atorus Research | Beyond One-Off Validation: Sustaining the CAMIS Legacy through OpenVal's Continuous Lifecycle | INDIVIDUAL PRESENTATION ABSTRACTS: 1. The Final Map: Results and Lessons from the CAMIS Project Completion This talk summarizes the multi-year effort to document the nuances between SAS and R. We will share the final repository findings, focusing on "high-impact" discrepancies found in common clinical procedures and how they were resolved or documented for regulatory clarity. 2. A Regulatory Lens on Open-Source Software The FDA representative will discuss the current thinking on R-based submissions. The talk will focus on the importance of transparency in software selection and how projects like CAMIS assist reviewers in understanding "statistical software risk." 3. Ensuring Algorithmic Integrity The academic perspective will focus on why open-source is uniquely suited for clinical trials-specifically how the transparency of R packages allows for a level of methodology audit that proprietary "black box" procedures cannot match. 4. Sustaining the CAMIS Legacy through OpenVal Validation is not a point-in-time event. This presentation demonstrates how OpenVal takes the comparison logic of CAMIS and applies it to a subscription-based, automated validation pipeline. We will show how to handle package updates and dependencies while maintaining a GxP-compliant state.