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
Past Events
Active Comparator Studies - 22 Jan 2010, The Rembrandt Hotel, London, United Kingdom (1538)
Active Comparator Studies 2026
Important
Please, check "Active Comparator Studies" official website for possible changes, before making any traveling arrangements
