ドイハラ　ヒロヨシ   Hiroyoshi Doihara   土井原　博義    所属   川崎医科大学  医学部 臨床医学　総合外科学    職種   特任教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Participants in a randomized controlled trial had longer overall survival than non-participants: a prospective cohort study.
掲載誌名	正式名：Breast cancer research and treatment 略　 称：Breast Cancer Res Treat ISSNコード：15737217/01676806
掲載区分	国外
巻・号・頁	176(3),pp.631-635
著者・共著者	Ohno Shinji, Mukai Hirofumi, Narui Kazutaka, Hozumi Yasuo, Miyoshi Yasuo, Yoshino Hiroshi, Doihara Hiroyoshi, Suto Akihiko, Tamura Motoshi, Morimoto Takashi, Zaha Hisamitsu, Chishima Takashi, Nishimura Reiki, Ishikawa Takashi, Uemura Yukari, Ohashi Yasuo
発行年月	2019/08
概要	PURPOSE:While some studies show improved outcomes in clinical trial participants as compared to non-participants, existence of such a trial effect has not been proved precisely.METHODS:This was a prospective cohort study to compare the prognoses for participants in the randomized controlled trial (SELECT BC) and non-participants. SELECT BC compared S-1 and taxane as first-line treatment for metastatic breast cancer. Non-participants were all patients who met the eligibility criteria of SELECT BC and who had been requested to participate in that trial by attending doctors and declined. The study aimed to compare the prognoses between participants and non-participants. The primary endpoint was median overall survival.RESULTS:The median OS in participants was significantly superior to that in non-participants with a statistically significant difference (36.8 months vs. 25.2 months. HR 1.48, p = 0.022). A similar result was obtained when only patients who received the same chemotherapy (S-1 or taxane) used in SELECT BC after declining participation were assumed as non-participants (36.8 months vs. 22.0 months. HR 2.03, p = 0.006).CONCLUSIONS:This study may suggest the existence of a trial effect, in which, for a given treatment, participation in a clinical trial is associated with a better outcome.
DOI	10.1007/s10549-019-05276-y
PMID	31115845