May 2024, Vol. 58, No. 3

Welcome to your May issue of Therapeutic Innovation & Regulatory Science (TIRS)! As a DIA member, you have full access to both the articles below and the complete archive online. Please also visit the TIRS Collections where you can find special sections as well as published articles and calls for papers within emerging healthcare topics.

TIRS is a Transformative Journal (TJ), actively committed to becoming a fully Open Access journal. Learn more about publishing Open Access in TIRS.

Table of Contents 

Letter to the Editor

•The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data

Reviews

•Approaches to Design an Efficient, Predictable Global Post-Approval Change Management System that Facilitates Continual Improvement and Drug Product Availability | Open Access 

•The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data | Open Access 

•The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today | Open Access

Analytical Reports

•Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method | Members Only Access

•Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa | Open Access 

•Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting | Members Only Access

•Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework | Open Access

Original Research

•The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power | Open Access 

•Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework | Members Only Access

•A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies | Open Access 

•Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials | Open Access 

•Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe | Open Access 

•Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials | Open Access 

•Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia | Members Only Access

•New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance | Members Only Access

•A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy | Members Only Access

•Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations | Open Access 

•Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry | Open Access