AUTHOR=Kunos Charles A. , Capala Jacek , Dicker Adam P. , Movsas Benjamin , Ivy Susan Percy , Minasian Lori M. TITLE=Clinical Outcome Assessments Toolbox for Radiopharmaceuticals JOURNAL=Frontiers in Oncology VOLUME=9 YEAR=2019 URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01028 DOI=10.3389/fonc.2019.01028 ISSN=2234-943X ABSTRACT=

For nearly 40 years, the U.S. National Cancer Institute (NCI) has funded health-related quality-of-life (HRQOL) and symptom management in oncology clinical trials as a method for including a cancer patient's experience during and after treatment. The NCI's planned scope for HRQOL, symptom and patient-reported outcomes management research is explained as it pertains to radiopharmaceutical clinical development. An effort already underway to support protocol authoring via an NCI Cancer Therapy Evaluation Program (CTEP) Centralized Protocol Writing Service (CPWS) is described as this service aids incorporation of HRQOL, symptom and patient-reported outcomes management research into sponsored protocols.