Clinical Drug Development
Life Sciences & Medicine
Continuing Professional Development (CPD)
Available course dates:
To be confirmed
*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 7BBP0005
Clinical development probably represents the most costly and therefore, one of the most critical stages of medicine development. Key to the success of clinical development programs is the integration of the strands of activities associated with product registration. Significant delays to product sales can and do occur due to a failure of the processes in clinical development. The Clinical Drug Development module has a focus on the skills needed for a successful clinical development programme.
What does this course cover?
The module’s teaching sessions will:
- Explain the principles of clinical development strategies, target product profiles and other tools to assist in planning and execution of clinical development.
- Describe the links between regulatory, preclinical, early clinical and late stage clinical development activities.
- Illustrate the core activities of clinical development including the:
- Design of clinical trials including the endpoint selection, statistical principles and data management
- The need for ongoing non-clinical and pharmacology studies during clinical development – such as reproductive toxicology, the role of population kinetics and studies in special populations.
- Manufacturing considerations.
- Interpret the principles of clinical development to the specific situations including the development biotechnology products including real world evidence.
The lectures will cover:
- An introduction to the practical implementation of clinical development strategies.
- The clinical development team, who what when and why.
- Tools for linking elements of the clinical development stages – Target Product Profiles, GANTT charts and other tools.
- Outcomes in clinical trials and linking clinical trials to reimbursement strategies.
- The role of clinical pharmacology in early and late stage development – trial designs and analysis methods.
- Statistical consideration in clinical development including estimands and other ways of managing sample sizes.
- Data management in clinical development.
- Specific issues in the development of biotechnology products.
- Real world trials.
The lectures will be supported by syndicate exercises to apply the knowledge gained.
What will I achieve?
By the end of the module the students should be able:
- To apply the principles of clinical development strategies to a wide variety of scenarios including Biological Therapies, New chemical Entities and other products entering the commercial phase of drug development.
- To analyse and determine the preclinical, manufacturing and other supporting developments to enable and determine clinical development strategies.
- To create the product development plans, operational plans, statistical plans, publication plans and registration plans and associated documents to facilitate successful clinical development.
- To participate in the team environment of clinical development.
Who is this for?
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.
Suitable for individuals seeking to develop an intensive course in drug development e.g. pharmaceutical industry physicians.