Efficient Approaches of Case Registration and Data management in Clinical Trials

• Project/Area Number: 20590538
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Single-year Grants
• Section: 一般
• Research Field: Applied pharmacology
• Research Institution: Kyoto University
• Principal Investigator: UESHIMA Kenji Kyoto University, 大学院・医学研究科, 特定教授 (40213334)
• Co-Investigator(Kenkyū-buntansha): FUJIMOTO Akira 京都大学, 大学院・医学研究科, 研究員 (50456901) ; OBA Koji 北海道大学, 北海道大学病院, 助教 (30422926)
• Project Period (FY): 2008 – 2010
• Project Status: Completed (Fiscal Year 2010)
• Budget Amount: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000); Fiscal Year 2010: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000); Fiscal Year 2009: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000); Fiscal Year 2008: ¥2,080,000 (Direct Cost: ¥1,600,000、Indirect Cost: ¥480,000)
• Keywords: 臨床試験 / 倫理 / EBM研究 / EDC / 中央測定 / 電子登録

Research Abstract

To perform clinical trials, enrollment of adequate patients and collection of CRF (Case Report Form)s is very important. We concluded that to recruit patients and to perform data management smoothly, the board system of our institute with supporting doctors who are familiar to clinical trials and the EDC (Electric Data Capturing) system were important.

Research Products

• [Journal Article] 臨床試験の症例登録は一部の参加医師により大部分がなされるのか?:CASE-J試験によるパレートの法則の検証 (2011)
  • Author(s): 大江陽子, 上嶋健治, 大庭幸治, 福富まさ美, 井上房子, 高木真理子, 中本まり子, 小林純子, 田中佐智子, 保野慎治, 藤本明, 中尾一和
  • Journal Title: 臨床評価 38 Pages: 885-890
  • Peer Reviewed
• [Journal Article] Is pulse pressure a predictor of new-onset diabetes in high-risk hypertensive patients? : A subanalysis of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. (2010)
  • Author(s): Yasuno S, Ueshima K, Oba K, Fujimoto A, Hirata M, Ogihara T, Saruta T, Nakao K
  • Journal Title: Diabetes Care 33 Pages: 1122-1127
  • NAID: 120002484962
  • Peer Reviewed
• [Journal Article] Role of diabetes and obesity in outcomes of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. (2010)
  • Author(s): Nakao K, Hirata M, Oba K, Yasuno S, Ueshima K, Fujimoto A, Ogihara T, Saruta T.
  • Journal Title: Hypertens Res 33 Pages: 600-606
  • NAID: 10026397220
  • Peer Reviewed
• [Journal Article] Impact of left ventricular hypertrophy on the time-course of renal function in high-risk Japanese hypertensive patients : A subanalysis of the CASE-J trial. (2010)
  • Author(s): Ueshima K, Yasuno S, Oba K, Fujimoto A, Mukoyama M, Ogihara T, Saruta T, Nakao K
  • Journal Title: Circ J 74 Pages: 2132-2138
  • Peer Reviewed
• [Journal Article] Clinical significance of awake oscillatory ventilation in patients with heart failure and effects of open-heart surgery. (2010)
  • Author(s): Ueshima K, Kobayashi N, Yamazaki T, Saitoh M, Nakamura M, Nakao K
  • Journal Title: Clin Cardiol Volume: 33
  • Peer Reviewed
• [Journal Article] Is pulse pressure a predictor of new-onset diabetes in high-risk hypertensive patients? : A subanalysis of the candesartan antihypertensive survival evaluation in Japan(CASE-J)trial. (2010)
  • Author(s): Yasuno S, Ueshima K, Oba K, Fujimoto A, Hirata M, Ogihara T, Saruta T, Nakao K
  • Journal Title: Diabetes Care Volume: 33 Pages: 1122-1127
  • NAID: 120002484962
  • Peer Reviewed
• [Journal Article] Role of diabetes and obesity in outcomes of the candesaxtan antihypertensive survival evaluation in Japan(CASE-J)trial. (2010)
  • Author(s): Nakao K, Hirata M, Oba K, Yasuna S, Ueshima K, Fujimoto A, Ogihara T, Saruta T
  • Journal Title: Hypertens Res Volume: 33 Pages: 600-606
  • Peer Reviewed
• [Journal Article] Impact of left ventricular hypertrophy on the time-course of renal function in high-risk Japanese hypertensive patients : A subanalysis of the CASE-J trial. (2010)
  • Author(s): Ueshima K, Yasuno S, Oba K, Fujimoto A, Mukoyama M, Ogihara T, Saruta T, Nakao K
  • Journal Title: Circ J Volume: 74 Pages: 2132-2138
  • Peer Reviewed
• [Journal Article] 臨床試験の症例登録は一部の参加医師により大部分がなされるのか?:CASE-J試験によるパレートの法則の検証 (2010)
  • Author(s): 大江陽子, 上嶋健治, 大庭幸治, 福富まさ美, 井上房子, 高木真理子, 中本まり子, 小林純子, 田中佐智子, 保野慎治, 藤本明, 中尾一和
  • Journal Title: 臨床評価 Volume: 38 Pages: 885-890
  • Peer Reviewed
• [Journal Article] Long-term effects of candesartan and amlodipine on cardiovascular mortality and morbidity in Japanese high-risk hypertensive patients : Rationale, design, and characteristics of candesartan antihypertensive survival evaluation in Japan extension (CASE-J Ex). (2009)
  • Author(s): Ueshima K, Oba K, Yasuno S, Fujimoto A, Sato T, Fukiyama K, Azuma J, Ogihara T, Saruta T, Nakao K
  • Journal Title: Contemp Clin Trials 30 Pages: 97-101
  • Peer Reviewed
• [Journal Article] for the CASE-J Trial Group : Relationship between the achieved blood pressure and the incidence of cardiovascular events in Japanese hypertensive patients with complications : a Sub-analysis of the CASE-J trial. (2009)
  • Author(s): Ogihara T, Saruta T, Rakugi H, Fujimoto A, Ueshima K, Yasuno S, Oba K, Takeda K, Higaki J, Nakao K
  • Journal Title: Hypertens Res 32 Pages: 248-254
  • Peer Reviewed
• [Journal Article] The effects of cardiac complications on cardiovascular events in Japanese high-risk hypertensive patients : A subanalysis of CASE-J trial. (2009)
  • Author(s): Ueshima K, Yasuno S, Oba K, Fujimoto A, Ogihara T, Saruta T, Nakao K
  • Journal Title: Circ J 73 Pages: 1080-1085
  • NAID: 10025931490
  • Peer Reviewed
• [Journal Article] Clinical significance of left ventricular hypertrophy and changes in left ventricular mass in high-risk hypertensive patients : A subanalysis of the CASE-J trial. (2009)
  • Author(s): Yasuno S, Ueshima K, Oba K, Fujimoto A, Ogihara T, Saruta T, Nakao K
  • Journal Title: J Hypertens 27 Pages: 1705-1712
  • Peer Reviewed
• [Journal Article] Prognostic value of myocardial perfusion SPECT images in combination with the maximal heart rate at exercise testing in Japanese patients with suspected ischemic heart disease : A sub-analysis of J-ACCESS. (2009)
  • Author(s): Ueshima K, Yamashina A, Usami S, Yasuno Y, Nishiyama O, Yamazaki T, Nakao T, Nishimura T.
  • Journal Title: Ann Nucl Med 23 Pages: 849-854
  • NAID: 10026099641
  • Peer Reviewed
• [Journal Article] 慢性腎臓病を合併した脂質異常症患者を対象に、アトルバスタチンが推算糸球体濾過量を指標にした腎機能に及ぼす影響を検討する多施設共同研究実施の意義 (2009)
  • Author(s): 上嶋健治, 木村玄次郎, 今本美幸, 中尾一和
  • Journal Title: Therapeutic research 30 Pages: 1425-1426
• [Journal Article] Clinical significance of left ventricular fypertrophy and changes in left ventricular mass in high-risk hypertensive patients : A subanalysis of the CASE-J trial. 27 : 1705-1712 2009 (2009)
  • Author(s): Yasuno S, Ueshima K, Oba K, Fujimoto A, Ogihara T, Saruta T, Nakao K
  • Journal Title: J Hypertens 27 Pages: 1705-1712
  • Peer Reviewed
• [Journal Article] 慢性腎臓病を合併した脂質異常症患者を対象にアトルバスタチンが推算糸球体濾過量を指標にした腎機能に及ぼす影響検討する多施設共同研究実施の意義 (2009)
  • Author(s): 上嶋健治, 木村玄次郎, 今本美幸, 中尾一和
  • Journal Title: Therapeutic research 30 Pages: 1425-1426
• [Journal Article] The optimal target blood pressure for antihypertensive treatment in Japanese elderly patients with high-risk hypertension : A subanalysis of the candesartan antihypertensive survival evaluation in Japan (CASE-J) trial. (2008)
  • Author(s): Ogihara T, Nakao T, Fukui T, Fukiyama K, Fujimoto A, Ueshima K, Oba K, Shimamoto K, Matsuoka H, Saruta T, for the CASE-J Trial Group
  • Journal Title: Hypertens Res 31 Pages: 1595-1601
  • NAID: 10024361770
  • Peer Reviewed
• [Journal Article] CASE-J Studyの軌跡 : CASE-Jの参加医師について-誰が参加し、なぜ参加したのか? - (2008)
  • Author(s): 大庭幸治
  • Journal Title: 日本臨床 66 Pages: 28-32
• [Presentation] Current status of multi-national clinical trials in Japan. (2011)
  • Author(s): Ueshima K
  • Organizer: The 2nd Catholic International Clinical Trial Symposium
  • Place of Presentation: Seoul, Korea
  • Year and Date: 2011-01-07
• [Presentation] Pre-existing diabetes and cardiovascular risks in high-risk hypertensive patients : A subanalysis of the CASE-J Extension (CASE-J Ex) (2010)
  • Author(s): Ueshima K, Yasuno S, Ogihara T, Fukiyama K, Saruta T, Nakao K
  • Organizer: The 23rd Annual Meeting of International Society of Hypertension
  • Place of Presentation: Vancouver, Canada
  • Year and Date: 2010-09-28
• [Presentation] Pre-existing type 2 diabetes and history of coronary heart disease on cardiovascular risk in high-risk hypertensive patients : a subanalysis of the CASE-J trial. (2010)
  • Author(s): Yasuno S, Ueshima, K, Oba K, Ogihara T, Saruta T, Nakao K
  • Organizer: European Society of Cardiology 2010
  • Place of Presentation: Stockholm, Sweden
  • Year and Date: 2010-08-29
• [Presentation] Age-related differences in the effects of candesartan and amlodipine on left ventricular hypertrophy in high-risk hypertensive patients : CASE-Jsubanalysis. (2010)
  • Author(s): Ogihara T, Nakao K, Ueshima, K, Fujimoto A, Saruta T
  • Organizer: European Society of Cardiology 2010
  • Place of Presentation: Stockholm, Sweden
  • Year and Date: 2010-08-29
• [Presentation] Relation between achieved blood pressure level and the reduction of cardiovascular risk in high-risk hypertensive patients : A subanalysis of the CASE-J trial. (2010)
  • Author(s): Yasuno S, Ueshima, K, Oba K, Ogihara T, Saruta T, Nakao K
  • Organizer: European Society of Hypertension 2010
  • Place of Presentation: Oslo, Norway
  • Year and Date: 2010-06-21
• [Presentation] Long-term effects of candesartan and amlodipine on cardiovascular events in high-risk hypertensive patients : Results of CASE-J Extension. (2010)
  • Author(s): Nakao K, Ogihara T, Matsuoka H, Oba K, Yasuno S, Fujimoto A, Ueshima K, Saruta T.
  • Organizer: Hotline2 European Society of Hypertension 2010
  • Place of Presentation: Oslo, Norway
  • Year and Date: 2010-06-20
• [Presentation] Long-term effects of candesartan and amlodipine on cardiovascular events in high-risk hypertensive patients : Results of CASE-J Extension. (2010)
  • Author(s): Nakao K, Ogihara T, Matsuoka H, Oba K, Yasuno S, Fujimoto A, Ueshima K, Saruta T
  • Organizer: European Society of Hypertension 2010
  • Place of Presentation: Oslo, Norway
  • Year and Date: 2010-06-20
• [Presentation] Blood pressure indices and cardiovascular risk in high-risk hypertensive patients : A subanalysis of CASE-J trial (2010)
  • Author(s): Yasuno S, Ueshima K, Oba K, Fujimoto A, Ogihara T, Saruta T, Nakao K
  • Organizer: EuroPRevent 2010
  • Place of Presentation: Prague, Czech Republic
  • Year and Date: 2010-05-06
• [Presentation] Clinical study in the latest progress in the renin-Angiotensin research. Satellite symposium 2, Latest Progress in the Renin-Angiotensin Research. (2010)
  • Author(s): Ueshima K
  • Organizer: 14th International Congress of Endocrinology.
  • Place of Presentation: Kyoto, Japan
  • Year and Date: 2010-03-28
• [Presentation] Effects of ARB on new-onset diabetes in Japanese hypertensive patients. JES sponsored symposia 2, Clinical trials in cardiovascular endocrinology and metabolism. (2010)
  • Author(s): Ueshima K, Oba K, Yasuno S, Fujimoto A, Nakao K.
  • Organizer: 14th International Congress of Endocrinology
  • Place of Presentation: Kyoto, Japan
  • Year and Date: 2010-03-27
• [Presentation] 臨床試験の症例登録とデータマネージメルントを効率的に進めるための試み (2010)
  • Author(s): 上嶋健治, 中本まり子, 福富まさ美, 大江陽子, 井上房子, 高木真理子, 小林純子, 藤堂祥子, 嘉門郁代, 長谷長部美代子, 大庭幸治, 保野慎治, 藤本明, 中尾一和
  • Organizer: 第1回臨床試験研究会
  • Place of Presentation: 東京
  • Year and Date: 2010-01-22
• [Presentation] 臨床試験の症例登録は一部の参加医師により大部分がなされるのか?:CASE-J試験によるパレートの法則の検証 (2009)
  • Author(s): 大江陽子, 福富まさ美, 上嶋健治, 井上房子, 高木真理子, 中本まり子, 小林純子, 大庭幸治, 保野慎治, 藤本明, 中尾一和
  • Organizer: 第30回日本臨床薬理学会
  • Place of Presentation: 横浜
  • Year and Date: 2009-12-03
• [Presentation] Recent updates on JSH guideline 2009. (2009)
  • Author(s): Ueshima K
  • Organizer: The 18th Annual Scientific Meeting of Indonesian Heart Association, Symposium 4
  • Place of Presentation: Jakarata, Indonesia
  • Year and Date: 2009-06-13
• [Presentation] The role of ARBs in managing the macrovascular complication : Learning from CASE-J. (2009)
  • Author(s): Ueshima K
  • Organizer: 18th Annual Scientific Meeting of Indonesian Heart Association, Lunch Symposium
  • Place of Presentation: Jakarata, Indonesia
  • Year and Date: 2009-06-12
• [Presentation] 慢性腎臓病(CKD)を合併した脂質異常症患者を対象に、アトルバスタチンが推算糸球体濾過量(eGFR)を指標にした腎機能 (2009)
  • Author(s): 上嶋健治, 木村玄次郎, 今本美幸, 中尾一和
  • Organizer: 第21回腎と脂質研究会
  • Place of Presentation: 仙台
  • Year and Date: 2009-03-28
• [Book] エビデンス:CASE-J試験 循環器病ケースアプローチシリーズ1高血圧(東京)(小室一誠編) (2009)
  • Author(s): 上嶋健治, 中尾一和
  • Total Pages: 207
  • Publisher: 羊土社
• [Remarks] ホームページ
  • URL: http://plaza.umin.ac.jp/~kdaiebm/index.html