Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act-Reference-Cited by-同舟云学术

Comparison of the Quality of Phase Ⅲ Non-commercial Clinical Trials in Japan, the United States, and the United Kingdom before the Implementation of the New Japanese Clinical Trials Act

Published:2023-05-31 Issue:3 Volume:54 Page:95-101
ISSN:0388-1601
Container-title:Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
language:en
Short-container-title:Jpn. J. Clin. Pharmacol. Ther.

Author:

YAMAUCHI Sachiko¹,MIWA Yoshikazu²,IKEDA Masayuki³,UEDA Shinichiro¹

Affiliation:

1. Department of Clinical Research and Quality Management, Center of Clinical Research and Quality Management, Graduate School of Medicine, University of the Ryukyus, Japan

2. Department of Clinical Pharmacology and Therapeutics, Graduate School of Medical Sciences, University of the Ryukyus, Japan

3. Department of Medical Informatics, Kagawa University Hospital, Japan

Publisher

Japanese Society of Clinical Pharmacology and Therapeutics

Subject

Pharmacology (medical),Pharmacology

Link

https://www.jstage.jst.go.jp/article/jscpt/54/3/54_95/_pdf

Reference30 articles.

1. 1) Sawada T, Yamada H, Dahlöf B, Matsubara H; KYOTO HEART Study Group. Effects of valsartan on morbidity and mortality in uncontrolled hypertensive patients with high cardiovascular risks: KYOTO HEART Study ［retraction in Eur Heart J. 2013; 34（14）: 1023］. Eur Heart J. 2009; 30（20）: 2461‒9. doi: 10.1093/eurheartj/ehp363.

2. 2) Mochizuki S, Dahlöf B, Shimizu M, Ikewaki K, Yoshikawa M, Taniguchi I, et al.; Jikei Heart Study group. Valsartan in a Japanese population with hypertension and another cardiovascular disease （Jikei Heart Study）: a randomised, open-label, blinded endpoint morbidity-mortality study ［retraction in Lancet. 2013; 382（9895）: 843］. Lancet. 2007; 369（9571）: 1431‒9. doi: 10.1016/S0140-6736（07）60669-2.

3. 3) Uzu T, Sawaguchi M, Maegawa H, Kashiwagi A; Shiga Microalbuminuria Reduction Trial (SMART) Group. Reduction of microalbuminuria in patients with type 2 diabetes: the Shiga Microalbuminuria Reduction Trial (SMART) ［retraction in Diabetes Care. 2014; 37（3）: 888］. Diabetes Care. 2007; 30（6）: 1581-3. doi: 10.2337/dc06-2493.

4. 4) Narumi H, Takano H, Shindo S, Fujita M, Mizuma H, Kuwabara Y, et al.; Valsartan Amlodipine Randomized Trial Investigators. Effects of valsartan and amlodipine on cardiorenal protection in Japanese hypertensive patients: the Valsartan Amlodipine Randomized Trial ［retraction in Hypertens Res. 2017; 40（1）: 103］. Hypertens Res. 2011; 34（1）: 62-9. doi: 10.1038/hr.2010.186.

5. 5) Muramatsu T, Matsushita K, Yamashita K, Kondo T, Maeda K, Shintani S, et al.; NAGOYA HEART Study Investigators. Comparison between valsartan and amlodipine regarding cardiovascular morbidity and mortality in hypertensive patients with glucose intolerance: NAGOYA HEART Study ［retraction in Hypertension. 2018; 72（3）: e37-8］. Hypertension. 2012; 59 (3）: 580-6. doi: 10.1161/HYPERTENSIONAHA.111.184226.