Therapeutic Innovation & Regulatory Science (TIRS)! July 2024, Vol. 58, No. 4

Welcome to the July issue of Therapeutic Innovation & Regulatory Science (TIRS)! If you are DIA member, you have full access to both the articles below and the complete archive online. If not, please feel free to view the open-access articles. Become a DIA Member to view all current a future TIRS articles. Visit the TIRS Collections where you can find special sections as well as published articles and call 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

Commentary

•Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?

Reviews

• The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History | Open Access

 • Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials

 • Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics | Open Access

Analytical Reports

•How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions •

An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium | Open Access

 •Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis | Open Access

Original Research

•New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials •

Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints | Open Access

• International Comparison of Qualification Process for Medical Product Development Tools | Open Access 

• Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union

 • Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports

 •Benchmarking Site Activation and Patient Enrollment •Diversity Plans and Post marketing Studies: First Impressions of Anticipated Diversity Requirements in the United States 

•Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies 

•Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data 

•Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections 

•Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan 

•A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry 

•Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology 

•The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational Studies