2011 Fiscal Year Final Research Report
Risk-based protection of participants in un-notified clinical trials No-fault Compensation & Informed Consent-
| Project/Area Number |
21590592
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Applied pharmacology
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| Research Institution | Kyoto University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
YOKODE Masayuki 京都大学, 医学研究科, 教授 (20252447)
MINAMI Manabu 京都大学, 医学研究科, 助教 (90511907)
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| Co-Investigator(Renkei-kenkyūsha) |
NISHIMURA Hiromi 先端医療センター研究所, 血管再生研究グループ, 客員研究員 (10359440)
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| Project Period (FY) |
2009 – 2011
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| Keywords | 臨床試験・倫理 / 無過失補償 |
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| Research Abstract |
Un-notified clinical trials to the authorities are still allowed in Japan, other than IND/IDE trials. The Ethical Guidelines for Clinical Studies, the only regulation for those, were fundamentally revised and enacted in April 2009, which obligate researchers to take measures on compensation such as insurance in clinical trials to assess pharmaceuticals or medical devices.
Since casualty insurance companies have not accumulated know-how to estimate the risk of un-notified trials besides IND/IDE trials, compensation insurance remains inadequate in quality.
In order to overcome the situation, we have set a working group of'Risk-based protection of trial participants in un-notified clinical trials' among academic clinical institutes and a casualty company. The working group has investigated legal restriction for insurance, medical expense reduction system in the academic hospital, and an academic guideline for compensation in researcher-initiated un-notified clinical trials.
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[Journal Article] An exploratory clinical trial for combination wound therapy with a novel medical matrix and fibroblast growth factor in patients with chronic skin ulcers : a study protocol2012
Author(s)
Morimoto N, Yoshimura K, Niimi M, Ito T, Tada H, Teramukai S, Murayama T, Toyooka C, Takemoto S, Kawai K, Yokode M, Shimizu A, Suzuki S.
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Journal Title
Am J Transl Res
Volume: 4
Pages: 52-59
Peer Reviewed
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[Journal Article] Distinct characteristics of circulating vascular endothelial growth factor-A and C levels in human subjects2011
Author(s)
Wada H, Ura S, Kitaoka S, Satoh-Asahara N, Horie T, Ono K, Takaya T, Takanabe-Mori R, Akao M, Abe M, Morimoto T, Murayama T, Yokode M, Fujita M, Shimatsu A, Hasegawa K.
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Journal Title
Pros ONE
Volume: 6
Pages: e29351
DOI
Peer Reviewed
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[Journal Article] Safety and pharmacokinetics of recombinant human hepatocyte growth factor(rh-HGF) in patients with fulminanthepatitis : a phase I/II clinical trial, following preclinical studies to ensure safety2011
Author(s)
Ido A, Moriuchi A, Numata M, Murayama T, Teramukai S, Marusawa H, Yamaji N, Setoyama H, Kim ID, Chiba T, Higuchi S, Yokode M, Fukushima M, Shimizu A, Tsubouchi H.
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Journal Title
J Transl Med
Volume: 9
Pages: 55
DOI
Peer Reviewed
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[Journal Article] Effect of EP4 agonist(ONO-4819CD) for patients with mild to moderate ulcerative colitis refractory to 5-aminosalicylates : A randomized phase II, placebo-controlled trial2010
Author(s)
Nakase H, Fujiyama Y, Oshitani N, Oga T, Nonomura K, Matsuoka T, Esaki Y, Murayama T, Teramukai S, Chiba T, Narumiya S.
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Journal Title
Inflamm Bowel Dis
Volume: 16
Pages: 731-733
DOI
Peer Reviewed
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[Journal Article] Mulberry leaf ameliorates the expression profile of adipocytokines by inhibiting oxidative stress in white adipose tissue in db/db mice2009
Author(s)
Sugimoto M, Arai H, Tamura Y, Murayama T, Khaengkhan P, Nishio T, Ono K, Ariyasu H, Akamizu T, Ueda Y, Kita T, Harada S, Kamei K, Yokode M.
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Journal Title
Atherosclerosis
Volume: 204
Pages: 388-394
DOI
Peer Reviewed
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