PPT-Estimands at ICH
Author : cheryl-pisano | Published Date : 2017-01-12
Rob Hemmings Statistics and PK Unit manager MHRA CHMP member SAWP chair BSWP MSWG member Contents Need for a new framework Why ICH How Who When What What next
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Estimands at ICH: Transcript
Rob Hemmings Statistics and PK Unit manager MHRA CHMP member SAWP chair BSWP MSWG member Contents Need for a new framework Why ICH How Who When What What next Example to support discussion. Chrissie Fletcher . (. one of two EFPIA representatives on the ICH E9 Working Group). PSI/EFSPI 1-day scientific meeting 28-Sept-15. International Conference on Harmonisation of Technical Requirements. . at ICH. Presented . by Rob Hemmings. Problem statement. Lack of clarity in trial objectives:. Potential to confuse developers and decision makers. . Misleading . information to patients and prescribers. Sept 13, 2018. Elena Polverejan. Vladimir Dragalin. . Quantitative Sciences. Janssen R&D, Johnson & Johnson. 1. Estimands and Estimators? . 2. Outline. ICH E9(R1) Trial Planning Framework. Case Study:. . are. . the. . opportunities. in . oncology. ?. Evgeny Degtyarev. ASA BIOP/PSI/EFSPI Webinar, Nov 2020. Hematology Development Unit Biostatistics. Industry. Working Group on . Estimands. in Oncology.
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