Non-Inferiority Trials – Design and Analysis Issues
Oct 27 2014 1:30PM - Oct 27 2014 5:00PM | Ottawa Marriott Hotel
100 Kent Street
Ottawa, ON K1P5R7
The workshop will introduce the concept of non-inferiority trials and discuss design and analysis issues related to these trials and the reporting of results from these trials. In particular, issues related to the ability of a trial to demonstrate a difference between treatments if such a difference truly exists (assay sensitivity) and the factors identified in the ICH E10 that a non-inferiority trial must at least attempt to avoid to be credible will be considered. The principal difficulties in conducting these trials, as well as as the importance that changes in medical practice and standard of care can have on the integrity of these trials when the historical perspective has changed (constancy assumption) will be reviewed. The pivotal importance and issues related to the selection of the non-inferiority margin and the putative placebo analysis related to the new treatment will be considered. These issues and recommendations related to the planning and reporting of the results for non-inferiority trials will be considered in a hands-on exercise involving recently published non-inferiority trials.
Who Should Attend
Decision-makers, readers and users of the results from non-inferiority trials are the prime target audience with the emphasis on the critical appraisal aspects of such trials. The workshop will also inform developers of these trials by providing overall guidance on the key methodological aspects related to conceiving, implementing and conducting such trials.
At the conclusion of this tutorial, participants should be able to:
- Recognize the role of non-inferiority trials in comparing treatments
- Identify issues related to non-inferiority trials comparing new treatments to active controls
- Discuss the basis in conceiving and designing a non-inferiority trial
- Explain issues to be aware of with implementing, conducting and interpreting non-inferiority trials
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.