Program Overview
Participants will gain expertise in trial design, safety assessment, data analysis, and regulatory requirements, preparing them for careers in clinical research, medical affairs, and regulatory affairs within the pharmaceutical industry.
Program Outline
Degree Overview:
This 5-day short course delves into the intricacies of planning and conducting the first human clinical trial for a new drug.
- Design a First-in-Human Phase 1 clinical trial and adapt it based on emerging human data.
- Compare and contrast early-phase studies for biologics and small molecules.
- Understand the importance of biomarkers and pharmacodynamic data in Phase I trials.
- Navigate the regulatory landscape of Phase I trials.
Program Description:
The course combines lectures, interactive workshops, and case studies to provide a holistic learning experience. Participants will engage with real-world scenarios and gain hands-on experience in applying the acquired knowledge.
Outline:
Module 1: Introduction to Exploratory Drug Development
- Fundamentals of clinical pharmacology
- Ethical considerations in early-phase clinical trials
Module 2: Preclinical Data and Dose Selection
- Interpretation of in vitro and in vivo data
- Pharmacokinetic and pharmacodynamic principles
Module 3: First-in-Human Phase 1 Trial Design
- Study design considerations for single and repeat-dose studies
- Protocol development and documentation
- Patient recruitment and informed consent
Module 4: Key Safety Issues in Phase I Trials
- Assessment and mitigation of safety risks
- Adverse event reporting and management
- Data monitoring and safety committees
Module 5: Data Analysis and Interpretation
- Interpretation of pharmacokinetic and safety data
- Biomarker analysis and pharmacodynamic evaluation
Assessment:
- Continuous assessment through active participation in workshops and case studies
- Final written assignment analyzing a real-world Phase I trial
- Optional oral presentation of the written assignment
Teaching:
- Led by experienced faculty with expertise in clinical pharmacology, drug development, and regulatory affairs
- Interactive and engaging teaching methods
- Opportunity for individual and group work
Careers:
This program prepares individuals for careers in the pharmaceutical industry, particularly in roles related to clinical research, medical affairs, and regulatory affairs. Graduates can pursue positions such as:
- Clinical Research Associate
- Medical Science Liaison
- Regulatory Affairs Specialist
- Drug Development Scientist
Other:
- The course is offered by the Institute of Pharmaceutical Science at King's College London.
- It is a required component of the Diploma in Human Pharmacology awarded by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Medicine.
- The course fee is £2590 for full-fee students, £1670 for home students, and £2590 for overseas students.
- Minimum entry requirements include a medical degree or a 2:1 first degree in a relevant science subject.