The Pharmaceutical Industry Working Group on Estimands in Oncology in collaboration with PHUSE has started a Safety Task Force on estimands in safety, focusing on oncology. The Task Force will formulate recommendations regarding formulation and use of safety estimands in oncology clinical trials as well as identifying applications of estimands principles to help improve general safety reporting. Recommendations will include trial design, data collection, and analysis issues and ways to integrate clinical, statistical, operations, and data management aspects of study design and execution cooperatively. Key task force activities will include a dive into literature on the subject, formulation of recommendations, development of white papers, and preparation of journal manuscripts and conference presentations. For more information, please contact Jonathan Siegel at Jonathan.siegel@bayer.com. For information on the Pharmaceutical Industry Working Group on Estimands in Oncology, please visit www.oncoestimand.com or contact Working Group co-chairs, Degtyarev Evgeny at evgeny.degtyarev@novartis.com or Kaspar Rufibach at kaspar.rufibach@roche.com. |
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