[Industry Voice #14] ICH E9(R1) Addendum on Estimands and Sensitivity Analysis скачать в хорошем качестве

[Industry Voice #14] ICH E9(R1) Addendum on Estimands and Sensitivity Analysis

This episode of Industry Voice highlights a major area of any drug research process. Biostatistics is involved in every step of clinical research including trial design, protocol development, data management and clinical trial reporting. This time our guest is Kristina Bondareva, Head of Biostatistics at OCT Clinical. She will share her thoughts on the role of biostatistics in general, and also comment on the EMA adoption of the E9(R1) addendum on estimands and sensitivity analysis. 0:43 Main changes introduced by the addendum on estimands and sensitivity analysis 3:12 Sensitivity analysis and its relation to estimands 4:46 How has the new estimand framework been accepted by the clinical trials community 5:41 How does the estimand framenwork address the impact of Covid-19 pandemic 7:20 The process of choosing an appropriate estimand, and potential difficulties during implementation 9:04 Plans on implementing the new guideline 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...   ✉Reach out to become the next speaker: [email protected] ✉Submit an RFP for clinical services: [email protected] 📺 Webinar on ICH E9(R1) Addendum on Estimands and Sensitivity Analysis:    • [Webinar] ICH E9(R1) Addendum on Esti...   #octclinical #cro #biostatistics #industryvoice