P106: Impact of Global Regulatory Frameworks on Antimicrobial Clinical Trials: Design, Timelines, and Approval Outcomes
Poster Presenter
Nabeela Jahangeer
Student
University of Southern California United States
Objectives
This study aims to evaluate the influence of global regulatory frameworks on antimicrobial drug development, focusing on clinical trial design, methodology, timelines, and approval outcomes. Understanding the role of regulatory policies in shaping clinical trials is essential for expediting the development of novel antibiotics while maintaining safety and efficacy standards.
Method
An analysis of clinical trial data from ClinicalTrials.Gov, correlated with published studies from PubMed to identify trends in trial design, execution, and regulatory outcomes, up to February 2025. Comparative assessment of various regulatory frameworks, examining the impact of surrogate endpoints, adaptive trial designs, patient recruitment strategies, and approval processes on antimicrobial drug development.
Results
An analysis of 15 antimicrobial clinical trials revealed significant variations in trial design, approval timelines, and success rates across different regulatory bodies. Faster completion times for trials using adaptive designs or surrogate endpoints, but inconsistent acceptance rates among agencies. Accelerated antimicrobial development through certain regulatory pathways, counterbalanced by challenges in global drug availability due to inconsistent approval criteria and trial design acceptance. Challenges persist, particularly in low- and middle-income countries.
To enhance the efficiency of antimicrobial drug development and effectively combat antimicrobial resistance, the study recommends:
1. Wider adoption of innovative trial designs and surrogate endpoints,
2. Greater harmonization of global regulatory approaches and
3. Increased acceptance of novel trial methodologies across regulatory agencies
Conclusion
While global regulatory frameworks have positively impacted antimicrobial drug development through expedited approval pathways, significant challenges remain, especially in low- and middle-income countries.
