December 12, 2025 Emerging Therapies in Autosomal Dominant Polycystic Kidney Disease Autosomal dominant polycystic kidney disease (ADPKD) is the most...
December 3, 2025 Rare Disease COA Consortium Publication on Study Designs and Crafting Endpoints for Gene Therapy Development Programs in Rare Disease C-Path’s Rare Disease COA Consortium is delighted to share that “Study Designs and Crafting Endpoints...
July 14, 2025 Principles of good practice for concept definition in the context of translation and linguistic validation of clinical outcome assessments (COAs) Translation teams conducting translation and cultural adaptation find it paramount to properly describe concepts of items...
June 9, 2025 Delivering regulatory impact from consortium-based projects Multiple consortia have been established in the past two decades with the aim of tackling roadblocks in the development of...
May 13, 2025 Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development Tools This paper seeks to identify some of the complexities associated with determining meaningful change for endpoints derived from...
April 25, 2025 Developing digital health technologies for frontotemporal degeneration Frontotemporal degeneration (FTD) is a rare neurodegenerative disease in which patients can present with cognitive, behavioral...
April 3, 2025 Systematic review and consensus conceptual model of meaningful symptoms and functional impacts in early Parkinson’s Disease A comprehensive, patient-centered conceptual model of early Parkinson’s is lacking and is greatly needed.
March 24, 2025 A Tutorial and Use Case Example of the eXtreme Gradient Boosting (XGBoost) Artificial Intelligence Algorithm for Drug Development Applications Approaches to artificial intelligence and machine learning (AI/ML) continue to advance in the field of drug development.
March 21, 2025 Wrangling Real-World Data: Optimizing Clinical Research Through Factor Selection with LASSO Regression Data-driven approaches to clinical research are necessary for understanding and effectively treating infectious diseases.
March 13, 2025 Principles of good practice for translation of electronic clinical outcome assessments While many publications have outlined good practice recommendations for translation and electronic implementation of clinical...
