[Webinar] ICH E9(R1) Addendum on Estimands and Sensitivity Analysis скачать в хорошем качестве

[Webinar] ICH E9(R1) Addendum on Estimands and Sensitivity Analysis

Discover how the new framework will improve the way of designing and planning clinical trials and performing primary analyses and sensitivity analyses. The European Medicines Agency (EMA) adopted the E9(R1) addendum on estimands and sensitivity analysis in clinical trials effective July 30 2020. Bringing clarity to the concept of estimands and the key issues debated in E9(R1) will help to understand their purpose and impact on study design, statistical analyses and the study outcome. During the webinar you will learn about: 00:00 ICH E9(R1): How it all started 3:39 Estimands and intercurrent events 5:19 5 strategies for ICEs 10:13 Defining an Estimand 12:53 Aligning target of estimation, method of estimation, and sensitivity analysis, for a given trial objective 13:56 Considerations for Analysis: Treatment Policy 14:37 Considerations for Analysis: Composite Strategy 17:03 Considerations for Analysis: Hypothetical Strategy 18:46 Considerations for Analysis: While on Treatment 19:30 Considerations for Analysis: Principle Stratum 19:53 Estimands in Therapeutic Area Guidelines: Diabetes 22:27 Implementation in Semaglutide Studies 23:41 Estimands in Therapeutic Area Guidelines: Crohn’s Disease 24:24 Example: Rheumatoid Arthritis (Ratitch et al., 2020) 30:03 Concluding Notes The webinar is hosted by Kristina Bondareva, the Head of Biostatistics at OCT Clinical. Enjoy and subscribe to our YouTube channel to be the first to know about new content on clinical research. Webpage: https://oct-clinicaltrials.com/. Experience: https://oct-clinicaltrials.com/oct-ex.... Blog, articles, case studies: https://oct-clinicaltrials.com/resources. LinkedIn:   / oct-clinical-trials-in-central-and-eastern...   ✉Submit an RFP for clinical services: [email protected] Reach out to OCT Clinical team if you have any questions at [email protected] #biostatistics #ICH #E9R1 #cro #contractresearch #clinicaltrials