Active comparator trials can fulfil a number of needs from pivotal marketing approval studies, through label enhancements of an already marketed drug to post-marketing market support. The designs of such studies have their own special issues: superiority vs non-inferiority designs, choice of comparator, two arm or three arm placebo designs amongst many others.
This course aims to discuss the theoretical, operational, regulatory and statistical issues involved, using practical examples to encourage interactive discussion to share possible approaches to the design and implementation of active comparator trials.
Topics to be covered at this meeting: - Purposes of active comparator trials
- Design for studies
- Statistical considerations
- Regulatory documentation & safety monitoring
- Safety data collection & reporting
- Post-marketing comparator observational studies
