Research Summary: From Bench-to-Bedside: A Review of Clinical Trials in Drug Discovery and Development

Clinical trials are fundamental in drug development, bridging basic research and clinical application. This review outlines the four distinct phases of clinical trials (Phase I-IV), detailing their specific objectives from safety assessment to post-marketing surveillance. It identifies critical challenges such as ethical compliance, participant recruitment, and population diversity, while also highlighting the transformative role of innovative technologies like AI, big data, and digital health tools in addressing these issues and improving trial design and implementation.

Why it matters

This review underscores the essential role of clinical trials in advancing medical science and bringing new treatments to market. Effectively managing clinical trial challenges and leveraging technological advancements are crucial for accelerating drug development, improving patient outcomes, and maintaining public trust in pharmaceutical innovation.

Key insights

• Clinical trials are a critical, multi-phase process for drug development, connecting basic research with practical application.
• The four phases of clinical trials encompass safety assessment (Phase I), efficacy evaluation (Phase II), large-scale validation (Phase III), and post-marketing surveillance (Phase IV).
• Key challenges in clinical trials include ensuring ethical compliance, effective participant recruitment, and achieving diversity and representativeness in trial populations.
• Innovative technologies, including artificial intelligence, big data analytics, and digital health tools, are being leveraged to transform trial design and implementation, addressing identified challenges.

Source

arXiv — Computers and Society — https://arxiv.org/abs/2412.09378