Exploratory Drug Development

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme:

Pharmaceutical Medicine Non-Award (Part-time)

Module code 7MMM0003

Planning and conducting the first human clinical trial of a new medicine is an important step in the drug development pathway. Pre-clinical data generated in vitro and in vivo must be interpreted and used in a manner that allows a safe human trial to be conducted. A sound understanding of the basic scientific principles is paramount but equally important are the basic principles of clinical trial design and regulatory requirements. This module combines these elements to provide participants with the capability to facilitate the effective design and conduct of exploratory clinical studies with respect to tolerability, safety, pharmacokinetics and pharmacodynamics. The criteria for ‘go’ / ‘no-go’ decisions, assessment of the risk/benefit ratio, and dose-escalation in single and repeat-dose studies will be discussed with respect to the early clinical development plan and proof-of-concept.

By the end of this module participants will be able to:

• Evaluate the ethical issues relating to the study population in a Phase I trial.
• Critically appraise toxicological and pharmacological data to aid dose selection in Phase 1 clinical trials.
• Create a First-in-Human phase 1 clinical trial design and consider how this may need to be modified when human data become available.
• Compare and contrast early studies in humans with biologics and small molecules.
• Understand the key safety issues involved in a Phase I trial and how these can be assessed and mitigated.
• Be able to interpret pharmacokinetic and safety data generated during a Phase I trial and critically appraise their validity.
• Understand the importance of biomarkers and pharmacodynamic data generated during a Phase I trial.
• Understand the regulatory issues and procedures involved in a phase I trial.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.

The course will suit individuals seeking to develop a practical understanding of clinical pharmacology e.g., pharmaceutical industry physicians, medical affairs and regulatory affairs personnel.

Attendance at this short course is a required component of the Diploma in Human Pharmacology awarded by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Medicine.