Aim:
The purpose of this Module is to enable students to provide effective regulatory leadership within their organisations throughout the clinical development and the registration of a new medicine.
Learning outcomes
- Students will differentiate the different types of clinical study design and identify the pros and cons of each within the context of global regulatory requirements.
- Students will evaluate the medical, statistical, economic and operational principles underpinning the successful conduct of a clinical trial programme.
- Students will identify the activities required to ensure that data suitable for a product registration are derived from the clinical studies programme.
- Students will determine the strategic role of clinical study reports and summaries in obtaining an optimal product label.
- Students will understand the Regulatory Authorities' views of the clinical dossier.
Outline of Module topics:
- Designing the clinical programme: strategy for global development; the clinical trial programme; core protocol, pivotal studies, dose-finding, special studies, trial designs, patient numbers; statistical input (intention to treat, efficacy populations); pharmacoeconomics, pharmacogenomics
- Getting the trial underway: Clinical Trial Application strategy, special populations (paediatric, elderly, organ impairment), preclinical requirements, territories (trial locations: disease prevalence, patient populations, medical expertise), clinical trial registries
- Keeping the programme going: timescales, project management and costs
- Heath Authorities – Your Partner in Drug Development: understanding and interpreting regulatory guidelines for a global drug development, seeking and implementing scientific advice
- Ensuring the right outcome: writing and evaluating clinical reports and summaries, risk/benefit evaluation, risk management, the target product profile and optimal product labelling
- Evaluating the data at the Regulatory Authorities: philosophies and assessment techniques, common faults in clinical registration packages, achieving a Global Clinical Programme and dossier