記述言語：英語   掲載種別：研究論文（学術雑誌）  

This paper discusses the effects of armed conflict, economic sanctions, and natural catastrophes on ongoing clinical trials. We suggest that • stopping the accrual of new patients in clinical trials under such extreme conditions is acceptable. • research participants already receiving trial medication in such disruptive situations are to be considered highly vulnerable due to their medical dependency for ongoing treatment according to the approved clinical study protocol. • based on the present experience in Ukraine and Russia, we conclude that finishing ongoing trial treatments according to approved or amended protocols should be considered to be an ethical obligation of trial sponsors irrespective whether trial disruption is due to war, economic sanctions, or natural catastrophes. • it is important to devote more attention to the ethical challenges raised by such fundamentally disruptive situations to clinical trials generally in any region of the world.

DOI： 10.3389/fmed.2022.950409

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

INTRODUCTION: Studies have not sufficiently clarified the differences in citation impact between funded and non-funded clinical research papers. Hence, this study seeks to evaluate the relation between research funding status and clinical research papers' citation impact in different research fields using multiple evaluation indices. METHODS: In this cross-sectional bibliometric study, clinical research papers published by core clinical research hospitals in Japan were compared retrospectively in terms of times cited (TC), category normalized citation impact (CNCI), citation percentile (CP), journal impact factor (JIF), the Software to Identify, Manage, and Analyze Scientific Publications (SIGAPS) category, and whether they were the funded clinical research. The association between research funding status or the SIGAPS category and CNCI ≥ 2 was analyzed using logistic regression analysis. RESULTS: 11 core clinical research hospitals published 553 clinical research papers, of which 120 were non-funded and 433 were funded (public institution-funded and industry-funded). The study found that funded clinical research papers (public institution-funded and industry-funded) had significantly higher TC, CNCI, CP, and JIF than non-funded ones [TC: 8 (3-17) vs. 14 (8-31), p < 0.001; CNCI: 0.53 (0.19-0.97) vs. 0.87 (0.45-1.85), p < 0.001; CP: 51.9 (24.48-70.42) vs. 66.7 (40.53-88.01), p < 0.001; JIF: 2.59 (1.90-3.84) vs. 2.93 (2.09-4.20) p = 0.008], while the proportion of A or B rank clinical research papers of the SIGAPS category was not significantly different between the two groups (30.0 vs. 34.9%, p = 0.318). In the logistic regression analysis, having a CNCI ≥ 2 was significantly associated with research funding (public institution-funded and industry-funded) and publication in A or B rank journals of the SIGAPS category [research funding: Estimate 2.169, 95% confidence interval (CI) 1.153-4.083, p = 0.016; SIGAPS category A/B: Estimate 6.126, 95% CI 3.889-9.651, p < 0.001]. CONCLUSION: Analysis via multiple indicators including CNCI and the SIGAPS category, which allows for a comparison of the papers' citation impact in different research fields, found a positive relation between research funding status and the citation impact of clinical research papers.

DOI： 10.3389/fmed.2022.978174

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.3389/fmed.2022.966220

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記述言語：日本語   掲載種別：研究論文（大学，研究機関等紀要）  

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その他リンク： http://id.ndl.go.jp/bib/031918035

記述言語：日本語   掲載種別：研究論文（大学，研究機関等紀要）  

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その他リンク： http://id.ndl.go.jp/bib/031918034

記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Under-recruitment in clinical trials is an issue worldwide. If the number of patients enrolled is lower than expected, based on the required sample size, then the reliability of the study results and their validation tend to be impaired. The current study therefore evaluated factors associated with accelerating patient enrollment using data from an ongoing multicenter prospective cohort study. The researchers encouraged research institutions to accelerate patient enrollment via e-mail, newsletters, telephone calls, and site visits. We analyzed the relationship between several potential factors associated with acceleration of patient enrollment including site visits and patient enrollment in a real clinical study. Data were collected from 106 research institutions that participated in a multicenter prospective cohort study. Results showed that the following parameters differed in terms of patient enrollment and non-enrollment: urban area (47.2 vs. 67.6%, p = 0.04), clinical research coordinator (CRC) participation in data input to electronic data capture (EDC) (41.7 vs. 11.8%, p < 0.01), and site visit (38.9 vs. 11.8%, p < 0.01). A multivariate analysis revealed that patient enrollment was significantly associated with urban area (odds ratio [OR] 0.33, 95% confidence interval [CI] 0.12-0.86, p = 0.02), CRC participation in data input to EDC (OR 5.02; 95% CI 1.49-16.8; p < 0.01), and site visit (OR 4.54, 95% CI 1.31-15.7, p = 0.01). In conclusion, site visits and CRC participation in data input to EDC had a significant effect on patient enrollment promotion. Moreover, hospitals in rural areas were more effective in promoting patient enrollment than those in urban areas.

DOI： 10.3389/fphar.2021.753067

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

DOI： 10.33611/trs.2021-009

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記述言語：英語  

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

The purpose of this study was to conduct a factual survey to evaluate the type of clinical research support offered by service providers (supporters) in Japanese academic research organizations (AROs). From September to October 2018, we conducted an online questionnaire targeting researchers and supporters of AROs, including individuals supporting research and development (R&D) planning, as well as those involved in study management, biostatistics, coordination, data management, monitoring, and auditing. The number of responses was tabulated for each survey item. For items with written descriptions, we compiled summaries using the inductive regression method of qualitative research. Responses were obtained from 124 researchers, 258 supporters, and 40 AROs. None of the institutions responded that they had a performance index for all types of service providers, whereas 47% of institutions had an index for 1-3 types of service providers, and 40% of institutions had no index. Many institutions responded that they had a performance index for coordinators and data management, but few responded that there was a performance index for individuals engaged in R&D and study management. Furthermore, for all evaluations of AROs and researchers, the level of supporter satisfaction was low at only 20%. There was a discrepancy between the levels of researcher expectations and the actual contribution of R&D in the process of research planning. Our survey revealed that there is currently no performance index for services supporting clinical research. In future studies, we need to examine a performance index that accurately reflects the researcher attitudes revealed in this study.

DOI： 10.1111/cts.12942

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記述言語：日本語   出版者・発行元：(一社)日本インターベンショナルラジオロジー学会  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Gene therapy orphan medicinal products constitute a unique group of new drugs which in case of hereditary diseases are usually administered only once at an early age, in the hope to provide sufficient gene product to last for the entire life of the patients. The combination of an exceptionally large single payment and the life-long clinical follow-up needed for understanding the long-term benefits and safety of gene therapy, represent new types of scientific, financial, social and ethical challenges for the pharmaceutical industry, regulators and society. With special consideration of the uniqueness and importance of gene therapy, the authors propose a three points plan for a close cooperation between the pharmaceutical industry and society to develop orphan gene therapy. (1) In fully transparent health technology negotiations a close and long-lasting, contractually fixed cooperation should be established between the manufacturers and local health-care stakeholders for sharing the medical and scientific benefits, the financial risks as well as the burdens of the post-authorization clinical and regulatory development. (2) The parties should agree on a fair, locally affordable drug price without the usually very high premium price calculated to compensate for the low number of patients. In case of high manufacturing costs, the companies should offer prolonged, 15-20 years long payment by installment with risk-sharing, especially considering that the late outcome of the treatment is unknown. Society should assist scientifically and financially organizing a specific patient registry, treatment in specialized hospitals and adequate long-term follow-up of patients, the coordinated management of financial transactions related to the risk sharing program. (3) The post-authorization treatment and prolonged observation of additional new cases coordinated by society should provide real world data needed for the modern complex regulatory evaluation of gene therapy products by the competent authorities. We assume that fair sharing of the benefits and risks as well as a well-organized cooperation of society with the industry in collecting real world evidence might result in better drug evaluation and improved accessibility due to lower prices. The outlined concept might support gene therapy more efficiently than the presently requested outstandingly high prices.

DOI： 10.3389/fmed.2020.608249

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Expansion of data-driven research in the 21st century has posed challenges in the evolution of the international agreed framework of research ethics. The World Medical Association (WMA)'s Declaration of Helsinki (DoH) has provided ethical principles for medical research involving humans since 1964, with the last update in 2013. To complement the DoH, WMA issued the Declaration of Taipei (DoT) in 2016 to provide additional principles for health databases and biobanks. However, the ethical principles for secondary use of data or material obtained in research remain unclear. With such a perspective, the Working Group on Ethics (WGE) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP) suggests a closer scientific linkage in the DoH to the (Declaration of Taipei) DoT focusing specifically on areas that will facilitate data-driven research, and to further strengthen the protection of research participants.

DOI： 10.3389/fphar.2020.579714

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記述言語：英語  

[This corrects the article DOI: 10.3389/fphar.2020.579714.].

DOI： 10.3389/fphar.2020.637775

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

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掲載種別：研究論文（学術雑誌）  

© 2019 Life Science Publishing Co. Ltd. All rights reserved. Objectives Standard Operating Procedure (SOP) is needed to conduct investigator-initiated clinical trials. SOP templates for drug and medical device have been released on website, however, preparation processes for SOP depends on the institutions conducting a clinical trial. Moreover, no templates for regenerative medicine products are released. Here we created of SOP templates for regenerative medicine products, and also revised SOPs for drugs and medical devices. Methods First, we searched the notifications and guidelines relating investigator-initiated clinical trials. Then SOP templates for drug and medical device were updated to reflect the latest notifications and guidelines as of the end of March 2019. Then, based on them, SOP templates of regenerative medicine products were made. Results The drug and medical device SOP templates were updated according to the 18 notifications and 7 guidelines from December 2012 to March 2019, and a regenerative medicine product SOP templates were newly created according to the latest notifications and guidelines as of the end of March 2019. Conclusions The SOP templates for drugs, medical devices and regenerative medicine products were created and released on the JMACCT website. They can be browsed and used by clinical trial personnel. These SOP templates can also be used as an education and training.material. We hope that the proper use of these templates will help reduce or prevent deviations from GCP and regulations, and help achieve the quality control goals.

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Copyright © 2019 Ueda, Nishizaki, Homma, Sanada, Otsuka, Yasuno, Matsuyama, Yanagisawa, Nagao, Fujibayashi, Nojiri, Seo, Yamada, Devos and Daida. Background: The number of papers published by an institution is acknowledged as an easy-to-understand research outcome. However, the quantity as well as the quality of research papers needs to be assessed. Methods: To determine the relation between the number of published papers and paper quality, a survey was conducted to assess publications focusing on interventional clinical trials reported by 11 core clinical research hospitals. A score was calculated for each paper using Système d’interrogation, de gestionet d’analyse des publications scientifiques scoring system, allowing for a clinical paper quality assessment independent of the field. Paper quality was defined as the relative Journal impact factor (IF) total score/number of papers. Results: We surveyed 580 clinical trial papers. For each of the 11 medical institutions (a–k), respectively, the following was found: number of published papers: a:66, b:64, c:61, d:56, e:54, f:51, g:46, h:46, i:46, j:45, k:45 (median: 51, maximum: 66, minimum: 45); total Journal IF: a:204, b:252, c:207, d:225, e:257, f:164, g:216, h:190, i:156, j:179, k:219 (median: 207, maximum: 257, minimum: 156); relative Journal IF total score: a:244, b:272, c:260, d:299, e:268, f:215, g:225, h:208, i:189, j:223, k:218 (median: 225, maximum: 299, minimum: 189); and paper quality (relative Journal IF total score/ number of papers): a:3.70, b:4.25, c:4.26, d:5.34, e:4.96, f:4.22, g:4.89, h:4.52, i:4.11, j:4.96, k:4.84 (median: 4.52, maximum: 5.34, minimum: 3.70). Additionally, no significant relation was found between the number of published papers and paper quality (correlation coefficient, −0.33, P = 0.32). Conclusions: The number of published papers does not correspond to paper quality. When assessing an institution’s ability to perform clinical research, an assessment of paper quality should be included along with the number of published papers.

DOI： 10.3389/fphar.2019.01228

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掲載種別：研究論文（国際会議プロシーディングス）  

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掲載種別：研究論文（学術雑誌）  

Objectives: In a clinical trial-planning phase, to set the appropriate goal and to evaluate risks properly have major impacts on the success or failure of the clinical trial. Although check lists had been known such as SPIRIT statement and TransCelerate RACT (Risk Assessment Categorization Tool), these put emphases on the contents determined by the trial protocol such as data management, data analysis. Thus, we attempted to make a new risk assessment tool followed by quality by design to evaluate on the basis of research inherent risks and operational management process risks and also the risks originated from the trial design. Methods: We had created a new risk assessment tool with quality management plan template working group (WG) members consisted of researchers (medical doctors), ARO or CRO staffs, highly skilled R&D specialists in trial management and quality control operations in the pharmaceutical company. It should be noted that this WG supported as a commissioned project from the Center for Clinical Trial, Japan Medical Association. Results: We developed the risk assessment tool that will be able to assess the trial risks in terms of inherent risks and implementation system risks. We considered the risk assessment viewpoints in terms of study design, safety, research management and medical institutions. Conclusions: We supposed that this risk assessment tool will play the important role to conduct the clinical trial based on the quality management plan.

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Purpose To assess the clinical efficacy of cultivated oral mucosal epithelial transplantation (COMET) for the treatment of persistent epithelial defect (PED). Methods We treated 10 eyes of nine patients with PED (Stevens-Johnson syndrome: three eyes; thermal/chemical injury: five eyes; ocular cicatricial pemphigoid: two eyes) with COMET at Kyoto Prefectural University of Medicine, Kyoto, Japan from 2002 to 2008. Results Preoperatively, PED existed on over more than 50% of the corneal surface in seven eyes. Severe ocular surface inflammation with fibrovascular tissue surrounded the PED in all 10 eyes. At 24-weeks postoperative, PED had improved in all cases except 1 in which the patient was unable to return to the hospital (95% CI, 55.5-99.7; Wilcoxon signed-rank test, p = 0.0078). The preoperative median of logarithmic minimum angle of resolution was 1.85 (range 0.15-2.70), and 1.85, 1.85, and 1.52 at the 4th, 12th, and 24th postoperative week, respectively. The mean total preoperative ocular surface grading score was 7.0 (range 4-17). At 4 and 12 weeks postoperative, the total ocular surface grading score had improved significantly (p = 0.0020, p = 0.0078), and at 24 weeks postoperative, it was 3.0 (range 2-12, p = 0.0234). During the follow-up period (median 23.3 months, range 5.6-39.7 months), no recurrence of PED was observed in any eye, and long-term ocular surface stability was obtained. Conclusion COMET enabled complete epithelialization of PED and stabilization of the ocular surface in patients with severe ocular surface disease, thus preventing end-stage cicatrization and vision loss at a later stage. © 2014 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

DOI： 10.1111/aos.12397

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Purpose: To report the effectiveness, disease-specific outcomes, and safety of cultivated oral mucosal epithelial sheet transplantation (COMET), with the primary objective of visual improvement. Design: Noncomparative, retrospective, interventional case series. Participants: This study involved 46 eyes in 40 patients with complete limbal stem cell deficiency (LSCD) who underwent COMET for visual improvement. These LSCD disorders fell into the following 4 categories: Stevens-Johnson syndrome (SJS; 21 eyes), ocular cicatricial pemphigoid (OCP; 10 eyes), thermal or chemical injury (7 eyes), or other diseases (8 eyes). Methods: Best-corrected visual acuity (BCVA) and ocular surface grading score were examined before surgery; at the 4th, 12th, and 24th postoperative week; and at the last follow-up. Data on COMET-related adverse events and postoperative management were collected. The outcomes in each disease category were evaluated separately. Main Outcome Measures: The primary outcome was the change in median logarithm of the minimum angle of resolution (logMAR) BCVA at the 24th postoperative week. The secondary outcome was the ocular surface grading score. Results: Median logMAR BCVA at baseline was 2.40 (range, 1.10 to 3.00). In SJS, logMAR BCVA improved significantly during the 24 weeks after surgery. In contrast, the BCVA in OCP was improved significantly only at the 4th postoperative week. In 6 of the 7 thermal or chemical injury cases, logMAR BCVA improved after planned penetrating keratoplasty or deep lamellar keratoplasty. Grading scores of ocular surface abnormalities improved in all categories. Of 31 patients with vision loss (logMAR BCVA, >2) at baseline, COMET produced improvement (logMAR BCVA, ≤2) in 15 patients (48%). Visual improvement was maintained with long-term follow-up (median, 28.7 months). Multivariate stepwise logistic regression analysis showed that corneal neovascularization and symblepharon were correlated significantly with logMAR BCVA improvement at the 24th postoperative week (P = 0.0023 and P = 0.0173, respectively). Although postoperative persistent epithelial defects and slight to moderate corneal infection occurred in the eyes of 16 and 2 patients, respectively, all were treated successfully with no eye perforation. Conclusions: Long-term visual improvement was achievable in cases of complete LSCD. Cultivated oral mucosal epithelial sheet transplantation offered substantial visual improvement even for patients with end-stage severe ocular surface disorders accompanying severe tear deficiency. Patients with corneal blindness such as SJS benefited from critical improvement of visual acuity. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in anymaterials discussed in this article. © 2013 American Academy of Ophthalmology.

DOI： 10.1016/j.ophtha.2012.07.053

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掲載種別：研究論文（国際会議プロシーディングス）  

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Purpose: The purpose of this study was to investigate the activity of capecitabine and trastuzumab in patients with HER2-overexpressing metastatic breast caner resistant to both anthracyclines and taxanes. Method: From June 2003 and May 2006, 40 female patients with measurable or assessable metastatic breast cancer were enrolled and data from 38 patients were reviewed extramurally and analyzed. Patients were treated with weekly trastuzumab given at a dose of 2 mg/kg/day over 90 min (4 mg/kg/day on the first infusion) and capecitabine given at a dose 1,657 mg/m2/day during 21 days with a subsequent pause of 7 days. This cycle was repeated every 28 days. The primary endpoint was overall survival and secondary endpoints were progression-free survival and response rate. Result: A median of 4.5 cycles (range 1-9 cycles) were delivered. The median age was 53 (range 30-69 years). Median overall survival and progression-free survival was 22.3 and 4.1 months, respectively. Survival rate at 1 and 2 year was 81.6 and 47.4%, respectively. Response rate was 18.4% (95% CI, 7.7-34.3%). All evaluable patients have responded with two CR (5.3%), 5 PR (13.2%), 20 SD (52.6%), 8 PD (21.1%) and 3 NE (7.9%). Regarding the hematological toxicities, grade 1/2/3 neutropenia, grade 1/2 anemia, grade 1 thrombocytopenia and grade 1/2 liver dysfunction were also common. No treatment-related death was reported. Conclusion: The combination of capecitabine and trastuzumab is active and well-tolerated in patients with HER2-overexpressing breast caner resistant to both anthracyclines and taxanes.

DOI： 10.1007/s00280-008-0882-8

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掲載種別：研究論文（国際会議プロシーディングス）  

In this paper we introduce an editing support system for medical information, Which we developed. The system has three features to support collaborative works when professionals edit documents, Such as articles for magazines, Papers, And protocols together. One is "data reconstitution" That enables users to edit asynchronously at a distance. The second is "adaptive representation" That makes different representation for user classes. The last is "access control" That protects data from miss operation and maintains the independency of data. Using this system we have operate cancer information publication on the Web since October 2003. Now we provide treatment information based on PDQ® (Physician Data Query from National Cancer Institute), Drug information, Clinical trial information, And treatment result information. Each item of content is and will be stored into database independently and users who have responsibility for each item of content only edit or update each database and coordination between different specialists is virtually not needed.

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background. Perilla frutescens (perilla) is a herbal medicine used in Japanese traditional Kampo medicine. The present study was conducted to evaluate the anti-nephritic effects of perilla in HIGA mice that spontaneously develop high levels of serum immunoglobulin A (IgA) along with mesangial IgA deposition. Methods. A perilla decoction and its major active constituent, rosmarinic acid (RsA), were orally administrated to 10-week-old HIGA mice for 16 weeks. At study completion, we measured proteinuria and serum IgA levels and generated histological scores from kidney specimens. In addition, we measured concentrations of IgA in culture media of intestinal Peyer's patch cells and spleen cells obtained from the HIGA mice. Results. Perilla suppressed proteinuria, proliferation of glomerular cells, serum levels of IgA, glomerular IgA and IgG depositions in HIGA mice. Cultured Peyer's patch cells and spleen cells from perilla-treated mice produced significantly less IgA than controls. Rosmarinic acid, by itself, suppressed serum IgA levels and glomerular IgA deposition in HIGA mice. Cultured spleen cells from RsA-treated mice produced less IgA than controls. Conclusions. The perilla decoction may suppress IgA nephropathy, in part, through modulation of the intestinal mucosal immune system. These effects were caused by RsA acting synergistically with other constituents.

DOI： 10.1093/ndt/18.3.484

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：日本医科大学医学会  

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その他リンク： https://search-tp.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2022&ichushi_jid=J04260&link_issn=&doc_id=20220831380004&doc_link_id=10.1272%2Fmanms.18.252&url=https%3A%2F%2Fdoi.org%2F10.1272%2Fmanms.18.252&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_3.gif

記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

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記述言語：日本語   出版者・発行元：日本医療企画  

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記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

日本生命倫理学会COVID-19タスクフォースとブラジル生命倫理学会の共催によるWebinarシリーズ「COVID-19と生命倫理」のPart 3「パンデミックと研究倫理:民主主義、プラセボ、そして試験終了後アクセス」を、日本製薬医学会(JAPhMed)・国際製薬医学会(IFAPP)の後援により、2021年6月4日・11日の両日開催する。本稿ではこのWebinarに先立ち、COVID-19ワクチン緊急使用承認(EUA)下の「プラセボ対照試験」「試験終了後アクセス」について検討する。いくつかのCOVID-19予防mRNAワクチンは中間解析で高い有効率を示しEUAが与えられ、地球的規模の接種が進められている。しかし、当初計画された2年間の有効性及び次シーズンの接種時期、さらには長期的な安全性という重要課題の検証が困難な状況となっている。現在、EUAを取得したmRNAワクチンのプラセボ対照試験は、プラセボ群の参加者が実薬群にスイッチできるという試験デザインの変更が行われて継続されている。WHO専門委員会はこの試験デザインの科学的・倫理的妥当性を認めているが、一方でワクチンへのアクセスが困難又は不可能な地域でのプラセボ対照試験を容認する見解を示している。これは世界医師会による「ヘルシンキ宣言」や国際医学団体協議会(CIOMS)による倫理指針に反し、倫理的に許容できない。一方、日本やいくつかのアジア諸国のようにCOVID-19の有病率・死亡率が低い地域の研究者が大規模プラセボ対照グローバル試験に参加することは倫理的に許容しうる。感染が深刻な地域でのプラセボ対照試験の結果による恩恵を受けながら、自国はプラセボ対照の検証的試験に参加せず、他地域で有効性が証明されたワクチンを全国民分確保するという日本政府の対応は生命倫理の「正義」の原則に反する。しかしながら実際には、大規模接種が開始された後に日本でプラセボ対照検証的試験を行うことに国内でコンセンサスを得ることは困難であろう。このため、証明力は限定的とならざるを得ないが、全国民を登録する前向き症例登録コホート研究によって、被接種群と未接種群のリアルワールド・データ(RWD)により長期的有効性のエビデンスを得るための政府主導のイニシアチブや、地域規模の観察研究を推進することが必要である。さらには、mRNAワクチンの長期的安全性に関する基礎・非臨床研究において日本が貢献しうる領域があると考える。(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本臨床救急医学会  

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記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

日本生命倫理学会COVID-19タスクフォースとブラジル生命倫理学会の共催によるWebinarシリーズ「COVID-19と生命倫理」のPart 3「パンデミックと研究倫理:民主主義、プラセボ、そして試験終了後アクセス」を、日本製薬医学会(JAPhMed)・国際製薬医学会(IFAPP)の後援により、2021年6月4日・11日の両日開催する。本稿ではこのWebinarに先立ち、COVID-19ワクチン緊急使用承認(EUA)下の「プラセボ対照試験」「試験終了後アクセス」について検討する。いくつかのCOVID-19予防mRNAワクチンは中間解析で高い有効率を示しEUAが与えられ、地球的規模の接種が進められている。しかし、当初計画された2年間の有効性及び次シーズンの接種時期、さらには長期的な安全性という重要課題の検証が困難な状況となっている。現在、EUAを取得したmRNAワクチンのプラセボ対照試験は、プラセボ群の参加者が実薬群にスイッチできるという試験デザインの変更が行われて継続されている。WHO専門委員会はこの試験デザインの科学的・倫理的妥当性を認めているが、一方でワクチンへのアクセスが困難又は不可能な地域でのプラセボ対照試験を容認する見解を示している。これは世界医師会による「ヘルシンキ宣言」や国際医学団体協議会(CIOMS)による倫理指針に反し、倫理的に許容できない。一方、日本やいくつかのアジア諸国のようにCOVID-19の有病率・死亡率が低い地域の研究者が大規模プラセボ対照グローバル試験に参加することは倫理的に許容しうる。感染が深刻な地域でのプラセボ対照試験の結果による恩恵を受けながら、自国はプラセボ対照の検証的試験に参加せず、他地域で有効性が証明されたワクチンを全国民分確保するという日本政府の対応は生命倫理の「正義」の原則に反する。しかしながら実際には、大規模接種が開始された後に日本でプラセボ対照検証的試験を行うことに国内でコンセンサスを得ることは困難であろう。このため、証明力は限定的とならざるを得ないが、全国民を登録する前向き症例登録コホート研究によって、被接種群と未接種群のリアルワールド・データ(RWD)により長期的有効性のエビデンスを得るための政府主導のイニシアチブや、地域規模の観察研究を推進することが必要である。さらには、mRNAワクチンの長期的安全性に関する基礎・非臨床研究において日本が貢献しうる領域があると考える。(著者抄録)

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記述言語：日本語   出版者・発行元：(一社)日本臨床救急医学会  

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記述言語：英語   出版者・発行元：(一社)日本インターベンショナルラジオロジー学会  

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記述言語：日本語   出版者・発行元：(一社)日本インターベンショナルラジオロジー学会  

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記述言語：日本語   出版者・発行元：(一社)日本インターベンショナルラジオロジー学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本インターベンショナルラジオロジー学会  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：(一社)日本医療機器学会  

DOI： 10.4286/jjmi.89.388

CiNii Books

CiNii Research

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その他リンク： https://search.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2019&ichushi_jid=J05123&link_issn=&doc_id=20190815030009&doc_link_id=%2Fca6medin%2F2019%2F008904%2F010%2F0388-0395%26dl%3D0&url=http%3A%2F%2Fwww.medicalonline.jp%2Fjamas.php%3FGoodsID%3D%2Fca6medin%2F2019%2F008904%2F010%2F0388-0395%26dl%3D0&type=MedicalOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00004_2.gif

記述言語：日本語   出版者・発行元：技術情報協会  

CiNii Books

CiNii Research

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記述言語：日本語   出版者・発行元：(株)メディカル・パブリケーションズ  

CiNii Books

CiNii Research

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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記述言語：日本語   出版者・発行元：(株)臨床医薬研究協会  

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記述言語：日本語   出版者・発行元：(株)臨床医薬研究協会  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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その他リンク： https://search.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2017&ichushi_jid=J01471&link_issn=&doc_id=20171016210006&doc_link_id=issn%3D0386-3603%26volume%3D45%26issue%3D9%26spage%3D1433&url=http%3A%2F%2Fwww.pieronline.jp%2Fopenurl%3Fissn%3D0386-3603%26volume%3D45%26issue%3D9%26spage%3D1433&type=PierOnline&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00005_2.gif

記述言語：日本語   出版者・発行元：(株)メディカル・パブリケーションズ  

CiNii Books

CiNii Research

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記述言語：日本語   出版者・発行元：(株)メディカル・パブリケーションズ  

CiNii Books

CiNii Research

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

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担当区分：筆頭著者,　責任著者   記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(公財)日本眼科学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

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記述言語：英語   掲載種別：研究発表ペーパー・要旨（国際会議）   出版者・発行元：WILEY-BLACKWELL  

Web of Science

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：大道学館出版部  

CiNii Books

CiNii Research

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その他リンク： https://search.jamas.or.jp/link/ui/2011174596

記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本癌治療学会  

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記述言語：日本語   出版者・発行元：ライフサイエンス出版(株)  

臨床研究情報センター(TRI)は、文部科学省と神戸市により、全国のトランスレーショナルリサーチ(TR)を推進・支援するための拠点として2002年に設置された。TRIでは、臨床研究の体系的な基盤整備を目的として、がん、脳卒中、冠動脈疾患、再生医療分野、PET検診や遺伝子解析研究等の幅広い分野で、現在53試験、累計約110試験を包括的に推進・管理している。2004年以降文部科学省がんトランスレーショナルリサーチ事業に採択された11課題で、綿密な進捗管理を実施し、2つの治験実施に至っている。2008年から現在まで、文部科学省「橋渡し研究支援推進プログラム」において、全国の橋渡し研究の支援を行う7拠点機関の整備や拠点間のネットワーク形成をサポートする機関としての役割を任っており、本プログラム期間内に各拠点で少なくとも2つの医師主導治験を開始できることを目標にしている。2009年12月現在、すでに1拠点では1治験が進行中であり、別の拠点でも治験届が提出された(2010年6月現在、3拠点で各1治験進行中)。TRIでは従来のプロトコル作成支援、データセンター業務だけでなく、特許戦略、資金、研究組織、成果発表等のさまざまな観点でチームによる支援を実施してきた。これらの成果をふまえ、今日はTRIの活動を報告するとともに、今後の展望について述べる。(著者抄録)

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記述言語：日本語   出版者・発行元：(NPO)日本小児がん学会  

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記述言語：日本語   出版者・発行元：(NPO)日本小児がん学会  

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記述言語：日本語   出版者・発行元：(一社)日本神経学会  

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記述言語：日本語   出版者・発行元：(NPO)日本小児がん学会  

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記述言語：日本語   出版者・発行元：(株)篠原出版新社  

CiNii Books

CiNii Research

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その他リンク： https://search.jamas.or.jp/link/ui/2007224525

記述言語：日本語   出版者・発行元：(一社)日本脳卒中学会  

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記述言語：日本語   出版者・発行元：(一社)日本脳卒中学会  

本研究は大規模臨床試験(脳血管疾患の再発に対する高脂血症治療薬HMG-CoA還元酵素阻害薬の予防効果に関する研究)をモデルに効率的かつ高品質な電子的データ収集の仕組みの構築及び医師主導ランダム化比較試験(目標3000例・登録3年・追跡5年・主要エンドポイント;脳卒中再発)基盤の構築を行うことにある。まず、モデルの大規模臨床試験に即し、被験者の適格性判定と薬剤のランダム割付を瞬時に可能とするWeb登録・追跡システムを開発し、2006年3月現在、本システムを通じて730例が登録され、追跡データも集積しておりデータマネージメント作業が進行中である。症例報告書(CRF)予告・督促・問い合わせメール配信システムの運用により医師のCRF提出忘れは大幅に減少した。以上より本研究によって電子データ収集技術を利用した効率的かつ高品質なランダム化比較試験の実務基盤は整備され、この整備された基盤は脳卒中領域のみならず日本における臨床研究の水準向上と確固たる臨床的エビデンスの創生に寄与する可能性があるものと考えられた。

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記述言語：日本語   出版者・発行元：(一社)日本医療情報学会  

臨床研究における症例報告書(CRF)の収集業務に伴う負担を解消し、低コストで効率的に臨床研究データを遠隔収集するためのシステム構築について検討した。このシステムで使用するCRFは、Adobe Acrobat Professionalを用いてデータ入力項目と適切な論理チェックを行い、医師が入力した段階で論理チェックが行えるようにした。電子CRFからのデータ抽出は一括してXML形式で行い、これらを用いて臨床研究データ遠隔収集システムを構築した。このシステムにより、低コストで効率的な臨床研究遠隔収集システムの構築が実現し、複数の臨床研究に適用している。このシステムを検証するため、CRFの項目数が約40,収集症例数が約1000例の臨床研究をモデルとし、症例を登録中である。このシステムを適用すれば、低予算の臨床研究も実施可能になると思われた。

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記述言語：日本語   出版者・発行元：日本小児血液学会  

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記述言語：日本語   出版者・発行元：(一社)日本癌治療学会  

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記述言語：日本語   出版者・発行元：(一社)日本脳卒中学会  

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記述言語：日本語   出版者・発行元：(一社)日本脳卒中学会  

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記述言語：日本語   出版者・発行元：がんの子供を守る会  

CiNii Books

CiNii Research

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その他リンク： https://projects.repo.nii.ac.jp/?action=repository_uri&item_id=262620

記述言語：日本語   出版者・発行元：(一社)日本医療情報学会  

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記述言語：日本語   出版者・発行元：(一社)日本癌治療学会  

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記述言語：日本語   出版者・発行元：(株)臨床評価刊行会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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記述言語：日本語   出版者・発行元：(一社)日本臨床薬理学会  

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その他リンク： https://search-tp.jamas.or.jp/index.php?module=Default&action=Link&pub_year=2004&ichushi_jid=J01568&link_issn=&doc_id=20040301340067&doc_link_id=10.3999%2Fjscpt.35.68S&url=https%3A%2F%2Fdoi.org%2F10.3999%2Fjscpt.35.68S&type=J-STAGE&icon=https%3A%2F%2Fjk04.jamas.or.jp%2Ficon%2F00007_2.gif

記述言語：日本語   出版者・発行元：(一社)和漢医薬学会  

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記述言語：日本語   出版者・発行元：(公社)日本薬学会  

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J-GLOBAL

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J-GLOBAL

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