Early Phase Clinical Research

Early phase clinical research is a bridge between early discovery and clinical research. As an exploratory study, early phase clinical research has a small sample size with limited data and some uncertainties. Its research content is changeable, characterized by diversification of high risk. The adoption of appropriate early-phase clinical research strategies and technologies provides an important guarantee for the success of drug research and development and can help companies manage their R&D expenses effectively.

This module focuses on early phase clinical research and explains the characteristics and knowledge of a drug’s early development based on clinical pharmacology. The workshop also covers important considerations in the design of early-phase clinical trials and offers guidance at the strategic level with regard to different indications (e.g., eye diseases, CNS disorders, oncological diseases) and different types of drugs (e.g., macromolecules and micromolecules) to help break through the bottleneck in innovative drug research and development.

Werkstatt Objective

• Master the characteristics of the early development of specific drugs and essential clinical pharmacological knowledge
• Acquire the key strategic considerations in early phase clinical research

Werkstatt Outline

• From the perspective of clinical pharmacology, explain core knowledge involved in early phase drug development as well as the characteristics of developing specific drugs
• Important considerations in early phase clinical research
  • Introduce the overview of early phase clinical research
  • Explain the important considerations during this process
  • Share the key points (e.g., the first-in-human clinical trial, drug-drug interaction test, TQT (c-QT) test, liver/kidney injury test) of a successful clinical pharmacological research through case studies