TY - JOUR AU - Lawrance, Rachael AU - Degtyarev, Evgeny AU - Griffiths, Philip AU - Trask, Peter AU - Lau, Helen AU - D’Alessio, Denise AU - Griebsch, Ingolf AU - Wallenstein, Gudrun AU - Cocks, Kim AU - Rufibach, Kaspar PY - 2020 DA - 2020/08/24 TI - What is an estimand & how does it relate to quantifying the effect of treatment on patient-reported quality of life outcomes in clinical trials? JO - Journal of Patient-Reported Outcomes SP - 68 VL - 4 IS - 1 AB - Published in 2019, a new addendum to the ICH E9 guideline presents the estimand framework as a systematic approach to ensure alignment among clinical trial objectives, trial execution/conduct, statistical analyses, and interpretation of results. The use of the estimand framework for describing clinical trial objectives has yet to be extensively considered in the context of patient-reported outcomes (PROs). We discuss the application of the estimand framework to PRO objectives when designing clinical trials in the future, with a focus on PRO outcomes in oncology trial settings as our example. SN - 2509-8020 UR - https://doi.org/10.1186/s41687-020-00218-5 DO - 10.1186/s41687-020-00218-5 ID - Lawrance2020 ER -