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Published Papers 【 display / non-display 】

• Errors Identified by Early, Risk-adapted, Triggered On-site Monitoring in Physicianinitiated Clinical Trials not for Regulatory Approval in Cardiovascular Diseases

  Ikehara Y.

  臨床薬理 ( 一般社団法人 日本臨床薬理学会 )  54 ( 1 ) 9 - 16   2023.01 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  <p><b>Background/Aims</b>: Many physician-initiated clinical trials not for approval have been conducted in Japan, but vulnerable quality management was unmasked with the finding of misconduct in trials. While monitoring has become mandatory with the implementation of the Clinical Research Act of Japan, the errors occurring in such trials were not fully recognized. The aim of the present study was to clarify errors through early, risk-adapted, on-site monitoring of physician-initiated clinical trials involving patients with cardiovascular diseases. </p><p><b>Methods</b>: Early, risk-adapted, on-site monitoring was undertaken at 15 hospitals where 3 multicenter, randomized, controlled trials that enrolled 884 patients were conducted. The selection of facilities was based on the results of early central monitoring. Monitoring items were selected according to the risk assessment of each trial. The errors detected including their effects on the quality of trials were described. </p><p><b>Results</b>: Of the 176 cases monitored, 71 procedural and 13 recording errors, including 32 in the process of informed consent, 17 in the selection of patients, 17 in randomization, 6 in the trial intervention, 3 in the outcome measures, and 2 in reporting serious adverse events (SAEs), were identified. Nine of the procedural errors regarding informed consent, selection of patients, and randomization were considered serious, whereas all recording errors were not serious. The steering committee revised the study protocol and the standard operation procedure of one study to prevent these errors.</p><p><b>Conclusion</b>: This risk-adapted, early monitoring triggered by central monitoring showed that a number of errors occurred in physician-initiated clinical trials, particularly, during patient enrolment, and such early monitoring might help investigators detect and address serious errors to improve the quality of ongoing clinical trials before they become uncorrectable.</p>

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• Study Protocol for a Randomized Double-blind Placebo-controlled Phase 2 Clinical Trial to Assess Anti-inflammatory Effect of Colchicine(DRC3633)in Mild to Moderately Severe COVID‒19 Patients(DRC‒06C)

  Kinjo T.

  臨床薬理 ( 一般社団法人 日本臨床薬理学会 )  53 ( 6 ) 199 - 205   2022.11 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  <p><b>Introduction</b>: Given that coronavirus disease 2019 (COVID-19) aggravation is associated with an excessive host immune response, complementary anti-inflammatory treatment is recommended in severe disease. Although dexamethasone is a widely used anti-inflammatory agent in COVID‒19 patients with respiratory failure, its use in patients with mild COVID‒19 not receiving oxygen could have harmful effects. Colchicine, an anti-inflammatory drug, blocks the upstream immune response by inhibiting NALP3 inflammasome activation. This study aimed to assess the efficacy and safety of low-dose colchicine (DRC3633) in mild COVID‒19.</p><p><b>Methods</b>: This study is a prospective, multicenter, placebo-controlled, double-blind randomized, phase 2 clinical trial patients with moderate COVID-19 admitted at nine hospitals in Japan (jRCT2071200078). The primary endpoint is area under the curve (AUC) for the amount of change of serum hypersensitive C-reactive protein (hs-CRP) from baseline to 1, 2, and 4 weeks after initiating investigational drug. Study participants will be randomly assigned to the colchicine or placebo group at a 1:1 ratio. On day 1, patients in the colchicine group will receive 1 mg of colchicine, followed by 0.5 mg of colchicine after 2 h barring gastrointestinal complications. From day 2 to 28, 0.5 mg of colchicine will be administered once daily.</p><p><b>Discussion</b>: An appropriate anti-inflammatory strategy is critical to improve the outcome of severe COVID-19 patients. This study will assess the efficacy of low-dose colchicine not only by the AUC of the amount of change in serum hs-CRP from baseline to several time points, but also by evaluating whether the result of the primary endpoint is consistent with other relevant biomarkers and clinical parameters measured as secondary endpoints.</p>

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• The clinical value of hepatojugular reflux on congestive heart failure: A meta-analysis.

  Iwata H, Miwa Y, Ikehara Y, Yodoshi T, Ueda S

  Journal of general and family medicine ( Journal of General and Family Medicine )  23 ( 6 ) 393 - 400   2022.11 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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• Effects of Low-Dose Colchicine on Serum High-Sensitivity C-Reactive Protein Level in Coronary Artery Disease Patients with Type 2 Diabetes Mellitus and Enhanced Inflammatory Response Protocol for a Randomized, Double-Blind, Placebo-Controlled, Phase 2, Dose-Finding Study.

  Miwa Y, Mutoh A, Morimoto T, Ikehara Y, Yasu T, Koba S, Ako J, Higashi Y, Kajikawa M, Uehara H, Ishikawa K, Sakuma I, Tomiyama H, Node K, Kumagai Y, Ueda S

  Biomedicine hub   7 ( 3 ) 156 - 164   2022.09 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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• Direct comparison of the reproducibility of in-office and self-measured home blood pressures.

  Asayama K, Ohkubo T, Rakugi H, Miyakawa M, Mori H, Katsuya T, Ikehara Y, Ueda S, Ohya Y, Tsuchihashi T, Kario K, Miura K, Ito S, Umemura S, Japanese Society of Hypertension Working Group on the COmparison of Self-measured home, Automated unattended office, Conventional attended office blood pressure (COSAC) study

  Journal of hypertension ( Journal of Hypertension )  40 ( 2 ) 398 - 407   2022.02 [ Peer Review Accepted ]

  Type of publication: Research paper (scientific journal)

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  OBJECTIVE: The aim was to compare short-term and long-term reproducibilities of in-office unattended blood pressure (BP), namely automated office blood pressure (AOBP), conventionally measured attended office BP, and self-measured home BP. METHODS: A multicentre, clinical study was conducted in Japan, and 287 Japanese outpatients on antihypertensive drug medication were followed-up for 1 year. RESULTS: The intensity of drug treatment was sustained consistently throughout the study period (defined daily doses, 1.62-1.68; P = 0.12). The mean SBP differences between baseline and 1 month later, as well as baseline and 1 year later, were less than 1.5 mmHg, whereas the standard deviations of the differences for home, AOBP, and attended office measurements for the 1-year interval were 7.7, 14.5, and 15.3 mmHg, respectively. The coefficients of variation were significantly smaller for home BP than for AOBP among all patients at both 1-month and 1-year intervals (P < 0.0001). In the 1-month interval, partial correlation coefficients of home BP (r, 0.73/0.88 for systolic/diastolic measures) were significantly higher than of conventional BP (r, 0.47/0.69). However, the correlations converged to the modest level regardless of BP information (r, 0.49-0.54/0.63-0.73) when the 1-year interval was assessed. Results were confirmatory when patients on the same drug regimen (n = 167) were analysed. CONCLUSION: A higher reproducibility of home BP was demonstrated compared with in-office BP, including AOBP. However, the modest correlations for the 1-year interval support the importance of regular assessment of BP, regardless of in-office or home measurements for treatment of hypertension.

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• 慢性疾患レジストリで橋をかける産官学そして患者 RCT on Registry,品質管理,標準化 慢性疾患レジストリと臨床試験実施における活用,RCT on registry

  植田 真一郎, 徳重 明央, 比嘉 真由美, 藤田 優子, 宇根 かおり, 池原 由美

  臨床薬理 ( (一社)日本臨床薬理学会 )  48 ( Suppl. ) S208 - S208   2017.11

   

• 医療機関におけるデータマネジメント(Site Data Management;SDM)の現状

  近藤 智子, 五百蔵 武士, 石井 涼子, 池原 由美, 末正 洋一, 南 千華子, 信谷 宗平, 太田 康之, 山原 有子, 小居 秀紀, 鈴木 千恵子, 久米 学, モニタリング2.0検討会ワーキンググループ10

  臨床薬理 ( (一社)日本臨床薬理学会 )  48 ( Suppl. ) S358 - S358   2017.11

   

• 臨床研究教育プログラム参加医師の背景分析に基づくキャリアパスの提案

  池原 由美, 大城 絢子, 齋藤 麻衣子, 植田 真一郎

  臨床薬理 ( (一社)日本臨床薬理学会 )  47 ( Suppl. ) S286 - S286   2016.10

   

• 研究計画書から始まる医師主導臨床研究の品質管理

  近藤 直樹, 池原 由美

  臨床薬理 ( (一社)日本臨床薬理学会 )  47 ( Suppl. ) S190 - S190   2016.10

   

• 循環器内科における医師主導臨床試験の特性を考慮した品質管理 効率的かつ効果的なモニタリングのためのリスクインジゲーターの設定

  池原 由美, 植田 真一郎

  日本心臓病学会学術集会抄録 ( (一社)日本心臓病学会 )  64回   P - 396   2016.09

   

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• PRIZE studyのモニタリングから医師主導臨床試験の品質管理を考える

  池原　由美

  PRIZE studyのモニタリングから医師主導臨床試験の品質管理を考える  2015.04  -  2015.04 

Preferred joint research theme 【 display / non-display 】

Preferred joint research theme 【 display / non-display 】

• Quality management in Clinical Reseach