Výsledky vyhledávání - "Satoru Tsuchiya"

Restricted mean survival time as a summary measure of time‐to‐event outcome

Autor: Shinichi Tanaka, Satoru Tsuchiya, Saori Misawa, Hiroyuki Ugai, Takanori Tanase, Yasuhide Yodo, Akira Wakana, Shintaro Nakagawa, Jpma Task Force Members, Hideki Suganami, Takahiro Hasegawa

Publikováno v: Pharmaceutical Statistics. 19:436-453

Many clinical research studies evaluate a time-to-event outcome, illustrate survival functions, and conventionally report estimated hazard ratios to express the magnitude of the treatment effect when comparing between groups. However, it may not be s

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::be8f16d811975f32ccd7755176e4725c
https://doi.org/10.1002/pst.2004

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Challenges on Multiple Endpoints in Clinical Trials: An Industry Survey in Japan

Autor: Satoru Tsuchiya, Hideki Suganami, Toshifumi Kamiura, Yusuke Morita, Katsuhiro Iba, Satoru Fukimbara, Seitaro Yoshida, Naoyuki Ogawa, Kentaro Sakamaki

Publikováno v: Therapeutic Innovation & Regulatory Science. 54:528-533

Two issues on clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, relationship between rare events and endpoints, and differences in multiplicity adjustment between regions; and (2) the current practice o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7d0cbfce4b50b777666b912e59810e1f
https://doi.org/10.1007/s43441-019-00084-4

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Multiplicity Adjustment and Sample Size Calculation in Clinical Trials with Multiple Endpoints: An Industry Survey of Current Practices in Japan

Autor: Seitaro Yoshida, Yusuke Morita, Toshifumi Kamiura, Satoru Tsuchiya, Kentaro Sakamaki, Katsuhiro Iba, Hideki Suganami, Satoru Fukimbara, Naoyuki Ogawa

Publikováno v: Therapeutic innovationregulatory science. 54(5)

Two issues in clinical trials with multiple endpoints were surveyed: (1) the terminology of multiple endpoints, the relationship between rare events and endpoints, and the differences in multiplicity adjustment between regions, and (2) the current pr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::39fd794d5fadd6074e726d2f0a0427e4
https://pubmed.ncbi.nlm.nih.gov/32030692

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Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan

Autor: Seitaro Yoshida, Toshifumi Kamiura, Akira Wakana, Katsuhiro Iba, Yusuke Morita, Satoru Fukimbara, Kentaro Sakamaki, Satoru Tsuchiya, Hideki Suganami

Publikováno v: Therapeutic Innovation & Regulatory Science. 50:846-852

This study provides the results of a survey on the current practice of multiplicity adjustment and sample size calculation in multi-arm clinical trials.The survey was aimed at members of the Japan Pharmaceutical Manufacturers Association (JPMA) and w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::efeb39c13d2f440635de567e5e936541
https://doi.org/10.1177/2168479016651660

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Current Practice in Japan for the Prevention and Treatment of Missing Data in Confirmatory Clinical Trials: A Survey of Japanese and Foreign Pharmaceutical Manufacturers

Autor: Satoru Tsuchiya, Yoichi M. Ito, Hideki Suganami, Satoru Fukinbara, Shiro Tanaka

Publikováno v: Therapeutic innovationregulatory science. 48(6)

This study aims to survey the current practice in Japan for the prevention and treatment of missing data in clinical trials since the publication of regulatory guidelines on missing data issues. A web-based questionnaire was conducted among 65 member

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4ca54bbf0dd147be5e066952424607b2
https://pubmed.ncbi.nlm.nih.gov/30227476

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Phase 1/2 study of the WT1 peptide cancer vaccine WT4869 in patients with myelodysplastic syndrome

Autor: Yasushi Miyazaki, Shigesaburo Miyakoshi, Yasunori Ueda, Kazuma Ohyashiki, Satoru Tsuchiya, Shuzo Tagashira, Takahiro Suzuki, Yuji Heike, Michinori Ogura

Publikováno v: Cancer Science

WT4869 is a synthetic peptide vaccine derived from the Wilms' tumor gene 1 (WT1) protein. This phase 1/2 open-label study evaluated the safety and efficacy of WT4869, and biomarkers for response, in patients with myelodysplastic syndrome. WT4869 (5-1

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::844687d72e42728bf028e3ddacd91a67
https://pubmed.ncbi.nlm.nih.gov/28949050

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A Phase 1/2 Study of WT1 Peptide Cancer Vaccine WT4869 in Patients with Myelodysplastic Syndromes (MDS)

Autor: Naokuni Uike, Yasushi Miyazaki, Makoto Murata, Shigesaburo Miyakoshi, Shuzo Tagashira, Takahiro Suzuki, Satoru Tsuchiya, Yasunobu Abe, Michinori Ogura, Keiya Ozawa, Michihiro Hidaka, Toshiki Uchida, Masahiro Kizaki, Yasunori Ueda, Kazuma Ohyashiki, Tomoki Naoe

Publikováno v: Blood. 126:2868-2868

Background: Based on its favorable effects on survival, azacitidine (AzaC) is now recognized as a first-line treatment option for higher-risk MDS. But the prognosis of patients who become resistant or intolerant to AzaC is still dismal (the median ov

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::d10184bdf1781f5cad86df855a5b4b94
https://doi.org/10.1182/blood.v126.23.2868.2868

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