Abstract
Introduction: Although data accumulated in clinical trials have higher accuracy compared with real-world data and are irreplaceably valuable, most previous clinical trial data have been left unused. Methods: The Japan Lung Cancer Society (JLCS) asked six clinical trial groups that conducted randomized clinical trials on curative chemoradiation for locally advanced NSCLC to provide data. After obtaining consent from all six groups, data were collected from August 2019 to June 2021. Results: A total of eight trials, JCOG9812, JCOG0301, NJLCG0601, OLCSG0007, WJTOG0105, WJOG5008L, SPECTRA, and TORG1018, were included. More than 3000 data items were integrated into 408 items by adjusting their definitions and units. The total number of collected cases was 1288: median age (range), 66 (30–93) years; sex (male/female) 1064/224; pathological type (squamous cell carcinoma, adenocarcinoma, other NSCLC, and unknown) 517, 629, 138, and 4; and stage IIIA and B, 536 and 752. The median overall survival was 26.0 months, with 2-, 5-, and 10-year survival rates of 53.7%, 24.8%, and 15.2%, respectively, in all enrollments. The median progression-free survival was 9.6 months, with 2-, 5-, and 10-year progression-free survival rates of 23.6%, 14.0%, and 9.4%, respectively. Part of the information in the database has been made available on the JLCS web page, and the JLCS members were provided the right to propose research using the database. Conclusions: The integration and sharing of clinical trial data for research purposes was made real by the nonprofit, academic organization, the JLCS. This database will lead to innovative researches and contribute to the improvement of lung cancer treatment and future research.
Original language | English |
---|---|
Article number | 100317 |
Journal | JTO Clinical and Research Reports |
Volume | 3 |
Issue number | 5 |
DOIs | |
Publication status | Published - May 2022 |
Keywords
- Database
- Japan Lung Cancer Society
- Locally advanced
- Non–small cell lung cancer
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
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Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society. / Ozawa, Yuichi; Yamamoto, Nobuyuki; Yamamoto, Kouji; Ito, Kentaro; Kenmotsu, Hirotsugu; Hayashi, Hidetoshi; Shukuya, Takehito; Fujimoto, Daichi; Sugawara, Shunichi; Niho, Seiji; Ohe, Yuichiro; Okamoto, Hiroaki; Nakagawa, Kazuhiko; Kiura, Katsuyuki; Yoshino, Ichiro; Gemma, Akihiko.
In: JTO Clinical and Research Reports, Vol. 3, No. 5, 100317, 05.2022.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Creation of an Integrated Clinical Trial Database and Data Sharing for Conducting New Research by the Japan Lung Cancer Society
AU - Ozawa, Yuichi
AU - Yamamoto, Nobuyuki
AU - Yamamoto, Kouji
AU - Ito, Kentaro
AU - Kenmotsu, Hirotsugu
AU - Hayashi, Hidetoshi
AU - Shukuya, Takehito
AU - Fujimoto, Daichi
AU - Sugawara, Shunichi
AU - Niho, Seiji
AU - Ohe, Yuichiro
AU - Okamoto, Hiroaki
AU - Nakagawa, Kazuhiko
AU - Kiura, Katsuyuki
AU - Yoshino, Ichiro
AU - Gemma, Akihiko
N1 - Funding Information: This work was supported by the Japan Lung Cancer Society. The authors express their sincere gratitude to Dr. Tomoyuki Yamada, Genomedia Inc., for his great support in building the database and the data-sharing system. The authors also thank Ms. Mayumi Ito, the secretary of the Japan Lung Cancer Society, for her efforts in creating and managing the database-sharing system. Funding Information: Disclosure: Dr. Ozawa reports receiving honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Merck Sharp & Dohme K.K., Ono Pharmaceutical Co., Ltd., Novartis Pharma K.K., and Takeda Pharmaceutical Co., Ltd. and serving as a member of the Advisory Board for AstraZeneca K.K. N. Yamamoto reports receiving honoraria from Merck Sharp & Dohme K.K., AstraZeneca K.K., Amgen K.K., Ono Pharmaceutical Co., Ltd., Guardant Health Japan Corp., TSUMURA & CO., Kyowa Kirin Co., Ltd., KOWA Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., and Novartis Pharma K.K. and funding from AstraZeneca K.K., Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Amgen K.K., Merck Sharp & Dohme K.K., Janssen Pharmaceutical K.K., Taiho Pharmaceutical Co., Ltd., Sanofi K.K., EPS Corporation, Eisai Co., Ltd., Bristol Myers Squibb, Sanofi K.K., AbbVie Inc., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Novartis Pharma K.K. K. Yamamoto reports receiving honoraria from Chugai Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., CMIC Holdings Co., Ltd., J-Pharma Co., Ltd., Craif Inc., Johokiko Co., Ltd., Triceps Co., Ltd., Kanagawa Prefectural Hospital Organization, and Kanagawa Medical Practitioners Association. Ito reports receiving honoraria from Boehringer Ingelheim, AstraZeneca K.K., Pfizer, Eli Lilly K.K., Chugai Pharmaceutical Co., Ltd., Merck Sharp & Dohme K.K., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd. Kenmotsu reports receiving honoraria from Novartis Pharma K.K., Daiichi-Sankyo Co., Ltd., AstraZeneca K.K., Ono Pharmaceutical Co., Ltd., Boehringer Ingelheim, Kyowa Hakko Kirin Co., Ltd., Merck Sharp & Dohme K.K., Pfizer , Taiho Pharmaceutical Co., Ltd., and Eli Lilly K.K. and research funding from Chugai Pharmaceutical Co., Ltd., Novartis Pharma K.K., Daiichi-Sankyo Co., Ltd., AstraZeneca K.K., and Loxo Oncology, Inc. Hayashi reports receiving honoraria from AstraZeneca K.K., Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd., Eli Lilly K.K., Kyorin Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Merck Sharp & Dohme K.K., Novartis Pharmaceuticals K.K., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Pfizer , and Takeda Pharmaceutical Co., Ltd.; receiving research funding from AstraZeneca K.K., Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd.; and having consulting or advisory role for AstraZeneca K.K., Boehringer Ingelheim, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd., Eli Lilly K.K., Shanghai Haihe Biopharm, Pfizer, and Takeda Pharmaceutical Co., Ltd. Shukuya reports receiving honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim, Novartis Pharma K.K., Merck Sharp & Dohme K.K., Taiho Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Nippon Kayaku Co., Ltd., and Pfizer and receiving research funding from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim, Novartis Pharma K.K., and Merck Sharp & Dohme K.K. Fujimoto reports receiving honoraria from AstraZeneca K.K., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Merck Sharp & Dohme K.K., Boehringer Ingelheim, and Eli Lilly K.K. and research funding from AstraZeneca K.K. and Boehringer Ingelheim. Sugawara reports receiving honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Merck Sharp & Dohme K.K., Boehringer Ingelheim, Pfizer, Taiho Pharmaceutical Co., Ltd., Eli Lilly K.K., Novartis Pharma K.K., Kyowa Hakko Kirin Co., Ltd., and Yakult. Niho reports receiving honoraria from Taiho Pharmaceutical Co., Ltd., Eli Lilly K.K., Bristol Myers Squibb, Nippon Kayaku Co., Ltd., Yakult, AstraZeneca K.K., Pfizer, Boehringer Ingelheim, Merck Sharp & Dohme K.K., Chugai Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., and Novartis Pharma K.K. and research funding from Taiho Pharmaceutical Co., Ltd., Lilly Japan, Sanofi K.K., AstraZeneca K.K., Pfizer, Boehringer Ingelheim, Merck Sharp & Dohme K.K., Chugai Pharmaceutical Co., Ltd., Pharma, Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Shionogi & Co., Ltd., Merck Serono Co., Ltd., and Teijin Pharma. Ohe reports receiving honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Eli Lilly K.K., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Boehringer Ingelheim, Bayer Yakuhin, Co., Ltd., Pfizer, Merck Sharp & Dohme K.K., Taiho Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., and Kyowa Hakko Kirin Co., Ltd. and funding from AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Lilly, Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Kyorin Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Oncology, Inc., Pfizer , Taiho Pharmaceutical Co., Ltd., Novartis Pharma K.K., Takeda Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd., Janssen Pharmaceutical K.K., and Loxo Oncology, Inc. Okamoto reports receiving honoraria from AstraZeneca K.K., Merck Sharp & Dohme K.K., Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim, Bristol Myers Squibb, Novartis Pharma K.K., and Kyorin Pharmaceutical Co., Ltd. and funding from Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Astellas Pharma Inc., Eli Lilly K.K., and Merck Biopharma Co., Ltd. Nakagawa reports receiving honoraria from AstraZeneca K.K., Nippon Kayaku Co., Ltd., Ono Pharmaceutical Co., Ltd., Astellas Pharma Inc., Bayer Yakuhin, Co., Ltd., Merck Biopharma Co., Ltd., Thermo Fisher Scientific K.K., Nanzando Co., Ltd., Novartis Pharma K.K., Medical Mobile Communications Co., Ltd., Nikkei Business Publications, Inc., Medicus Shuppan, Publishers Co., Ltd., Pfizer, Bristol Myers Squibb, Amgen Inc., Yodosha Co., Ltd., and Nichi-Iko Pharmaceutical Co., Ltd. and funding from Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., AbbVie Inc., GlaxoSmithKline K.K., PAREXEL International Corp, ICON Japan K.K., EPS Corporation, Kissei Pharmaceutical Co., Ltd., Pfizer, R&D Japan G.K., Syneos Health., IQVIA Services JAPAN K.K., A2 Healthcare Corp., CMIC Shift Zero K.K., Eisai Co., Ltd., SymBio Pharmaceuticals Limited, Kyowa Hakko Kirin Co., Ltd., Bayer Yakuhin, Co., Ltd., EPS International Co., Ltd., Otsuka Pharmaceutical Co., Ltd., PRA Health Sciences, Covance Japan Inc., Medical Research Support, Sanofi K.K., PPD-SNBL K.K., Japan Clinical Research Operations, Sysmex Corporation, and Mochida Pharmaceutical Co., Ltd. Kiura reports receiving honoraria from AstraZeneca K.K., Eli Lilly K.K., Novartis International AG, Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Pfizer., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Merck Sharp & Dohme K.K., Boehringer Ingelheim, Daiichi-Sankyo Co., Ltd., and funding from Daiichi-Sankyo Co., Ltd., Teijin Pharma, Pfizer, Shionogi & Co., Ltd., Boehringer Ingelheim, Nippon Kayaku Co., Ltd., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Merck Sharp & Dohme K.K., Chugai Pharmaceutical Co., Ltd., Bristol Myers Squibb, Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., and Novartis International AG. Yoshino reports receiving honoraria from AstraZeneca K.K., Johnson and Johnson, Chugai Pharmaceutical Co., Ltd., Covidien, Taiho Pharmaceutical Co., Ltd., and Intuitive Surgical; receiving funding from Taiho Pharmaceutical Co., Ltd., and Pfizer; and having consulting or advisory role for Johnson and Johnson, AstraZeneca K.K., Intuitive Surgical, and Covidien. Gemma reports receiving honoraria from Boehringer Ingelheim, Nippon Kayaku Co., Ltd., AstraZeneca K.K., Daiichi-Sankyo Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Publisher Copyright: © 2022 The Authors
PY - 2022/5
Y1 - 2022/5
N2 - Introduction: Although data accumulated in clinical trials have higher accuracy compared with real-world data and are irreplaceably valuable, most previous clinical trial data have been left unused. Methods: The Japan Lung Cancer Society (JLCS) asked six clinical trial groups that conducted randomized clinical trials on curative chemoradiation for locally advanced NSCLC to provide data. After obtaining consent from all six groups, data were collected from August 2019 to June 2021. Results: A total of eight trials, JCOG9812, JCOG0301, NJLCG0601, OLCSG0007, WJTOG0105, WJOG5008L, SPECTRA, and TORG1018, were included. More than 3000 data items were integrated into 408 items by adjusting their definitions and units. The total number of collected cases was 1288: median age (range), 66 (30–93) years; sex (male/female) 1064/224; pathological type (squamous cell carcinoma, adenocarcinoma, other NSCLC, and unknown) 517, 629, 138, and 4; and stage IIIA and B, 536 and 752. The median overall survival was 26.0 months, with 2-, 5-, and 10-year survival rates of 53.7%, 24.8%, and 15.2%, respectively, in all enrollments. The median progression-free survival was 9.6 months, with 2-, 5-, and 10-year progression-free survival rates of 23.6%, 14.0%, and 9.4%, respectively. Part of the information in the database has been made available on the JLCS web page, and the JLCS members were provided the right to propose research using the database. Conclusions: The integration and sharing of clinical trial data for research purposes was made real by the nonprofit, academic organization, the JLCS. This database will lead to innovative researches and contribute to the improvement of lung cancer treatment and future research.
AB - Introduction: Although data accumulated in clinical trials have higher accuracy compared with real-world data and are irreplaceably valuable, most previous clinical trial data have been left unused. Methods: The Japan Lung Cancer Society (JLCS) asked six clinical trial groups that conducted randomized clinical trials on curative chemoradiation for locally advanced NSCLC to provide data. After obtaining consent from all six groups, data were collected from August 2019 to June 2021. Results: A total of eight trials, JCOG9812, JCOG0301, NJLCG0601, OLCSG0007, WJTOG0105, WJOG5008L, SPECTRA, and TORG1018, were included. More than 3000 data items were integrated into 408 items by adjusting their definitions and units. The total number of collected cases was 1288: median age (range), 66 (30–93) years; sex (male/female) 1064/224; pathological type (squamous cell carcinoma, adenocarcinoma, other NSCLC, and unknown) 517, 629, 138, and 4; and stage IIIA and B, 536 and 752. The median overall survival was 26.0 months, with 2-, 5-, and 10-year survival rates of 53.7%, 24.8%, and 15.2%, respectively, in all enrollments. The median progression-free survival was 9.6 months, with 2-, 5-, and 10-year progression-free survival rates of 23.6%, 14.0%, and 9.4%, respectively. Part of the information in the database has been made available on the JLCS web page, and the JLCS members were provided the right to propose research using the database. Conclusions: The integration and sharing of clinical trial data for research purposes was made real by the nonprofit, academic organization, the JLCS. This database will lead to innovative researches and contribute to the improvement of lung cancer treatment and future research.
KW - Database
KW - Japan Lung Cancer Society
KW - Locally advanced
KW - Non–small cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85128554294&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85128554294&partnerID=8YFLogxK
U2 - 10.1016/j.jtocrr.2022.100317
DO - 10.1016/j.jtocrr.2022.100317
M3 - Article
AN - SCOPUS:85128554294
VL - 3
JO - JTO Clinical and Research Reports
JF - JTO Clinical and Research Reports
SN - 2666-3643
IS - 5
M1 - 100317
ER -