Accelerating Drug Development: Regulatory and Operational Strategies for Shortening Clinical Trials

Abstract

Ali Rahmani and Maedeh Dahaghin

This article explores various regulatory and operational strategies aimed at accelerating drug development by short- ening clinical trials. The length of traditional clinical trials presents challenges in delivering timely therapies to patients, making it crucial to identify approaches that expedite the process without compromising safety or data in- tegrity. The strategies discussed include adaptive trial designs, utilizing surrogate endpoints, leveraging real-world evidence, regulatory flexibility, streamlined protocols and procedures, and enhanced patient recruitment and en- rollment. By implementing these strategies, researchers can make informed decisions, expedite data analysis, and enhance trial efficiency. The article emphasizes the importance of collaboration among stakeholders to advance the field of clinical trials and bring innovative therapies to patients more quickly.

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