{'fraction_non_alphanumeric': 0.024597116200169637, 'fraction_numerical': 0.0, 'mean_word_length': 6.108433734939759, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Clinical Meaning and Operability of Endpoints in Cancer Clinical Trials: Example of Survey on RMST Threshold

Abstract Efficacy endpoints in clinical trial should have, as well as clinical meaning, high operability for measuring, summarizing and testing hypotheses by using statistical methodology. Constructing components of operability include surrogacy (for true endpoints as OS and QOL adjusted OS), less requirement for statistical assumptions (assuring comparative validity) or robustness against departure from assumptions, easiness of computation and high power or less required sample size. Recent interests in RMST(Restricted Mean Survival Time) lie in high requirement of clinical trials for patients with good prognosis and/or recognition to real situations where (hitherto implicitly postulated) proportional hazard assumption does not hold. In this presentation, significance and interpretation of RMST is discussed in the above context, and an example of survey on threshold of RMST to physicians who participated in the noninferiority clinical trial of trastuzumab (test treatment) vs trastuzumab+chemotherapy (standard therapy) for elderly women (RESPECT-trial).