PPT-Estimands
Author : mitsue-stanley | Published Date : 2017-09-29
at ICH Presented by Rob Hemmings Problem statement Lack of clarity in trial objectives Potential to confuse developers and decision makers Misleading information
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Estimands: Transcript
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. .. 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. 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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