Publications by authors named "Kotone Matsuyama"
Article Synopsis
- * The paper explores key aspects, including ethical reforms for including vulnerable participants to ensure diversity and the necessity of social value, especially for those in need.
- * It also discusses the requirements for promoting the inclusion of vulnerable groups, such as reevaluating placebo-controlled trial norms and post-trial access, and suggests directions for reforming research ethics to enhance social value and global health equity.
Background: Failure-free survival (FFS) rates of low-risk patients with rhabdomyosarcoma improved in Intergroup Rhabdomyosarcoma Study IV after the escalation of cyclophosphamide total dose to 26.4 g/m. However, this dose may increase the risk of adverse events, including infertility, in some patients.
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- All life science and medical research involving human subjects must adhere to the Declaration of Helsinki and relevant laws to ensure ethical compliance.
- Research proposals need to undergo review by qualified committees to ensure their scientific and ethical suitability before starting.
- The report details the ethical review processes established by the Nippon Medical School Foundation to help researchers stay informed about current regulations and guidelines.
The World Medical Association's Declaration of Helsinki is in the process of being revised. The following amendments are recommended to be incorporated in pursuit of the common goal of promoting health for all. 1.
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- Researchers studied apolipoprotein A2-isoforms (apoA2-is) as potential biomarkers for early-stage pancreatic cancer and developed a new diagnostic assay for them.
- The study included 2732 plasma samples and showed that apoA2-ATQ/AT has a higher ability to distinguish pancreatic cancer from healthy controls compared to the traditional biomarker CA19-9.
- ApoA2-ATQ/AT also demonstrated better sensitivity for detecting early-stage pancreatic cancers, and using it in combination with CA19-9 boosted detection rates significantly.
Article Synopsis
- The KEYNOTE-407 trial established pembrolizumab plus platinum-based chemotherapy as the standard treatment for advanced squamous non-small-cell lung cancer (NSCLC), and this study will evaluate the drug ubenimex when combined with this regimen.
- Conducted as a phase II clinical trial, patients will receive ubenimex along with pembrolizumab, nab-paclitaxel, and carboplatin, with a focus on establishing safety and efficacy through systematic dose escalation.
- This trial represents the first investigation of ubenimex in this combination treatment, and its findings could inform future therapeutic approaches for patients with advanced squamous NSCLC.
Advances in genomic research have significantly enhanced modern drug development. However, equitable benefit sharing of the results of scientific advancement has not always been achieved. This paper shows how molecular biology has modified medicines development while also leaving open significant challenges for benefit sharing.
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- Platinum-based combination therapy with PD-1/PD-L1 inhibitors is standard for stage IV non-small cell lung cancer, but necitumumab is specifically used with gemcitabine and cisplatin for squamous cell lung cancer (SqCLC).
- A new phase I/II study aims to evaluate the safety and efficacy of necitumumab combined with pembrolizumab and chemotherapy (nab-paclitaxel and carboplatin) for patients with untreated SqCLC.
- The study will assess tolerability and recommended doses in phase I, and the overall response rate, along with secondary outcomes like survival rates and safety, in phase II involving 42 patients.
Principal investigators (PIs) play a key role in clinical research, and must thus understand the role of clinical research support staff to conduct successful and appropriate clinical research. This study evaluates clinical research capabilities by examining the clinical research knowledge of PIs and clinical research support staff. The participants of this cross-sectional study were academic researchers and clinical research support staff from Japanese universities and research institutions.
View Article and Find Full Text PDFIntroduction: 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 ethical responsibility to continue investigational treatments of research participants in situation of armed conflicts, economic sanctions or natural catastrophes.
Front Med (Lausanne)
August 2022
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.
View Article and Find Full Text PDFUnder-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.
View Article and Find Full Text PDFGene 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.
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- The expansion of data-driven research in the 21st century has identified gaps in the existing ethical frameworks for research, particularly in the use of secondary data.
- The World Medical Association's Declaration of Helsinki, which outlines ethical principles for medical research, was last updated in 2013, and the Declaration of Taipei was introduced in 2016 to address health databases and biobanks.
- The International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine recommends enhancing the connection between these two declarations to better support data-driven research and protect participants' rights.
Article Synopsis
- * A total of 124 researchers, 258 supporters, and 40 AROs responded, revealing that 47% of institutions had performance indices for only a few types of service providers, with a notable lack of index for crucial roles like R&D and study management.
- * The findings indicated low satisfaction levels (20%) among supporters and a disconnect between researcher expectations and the actual research support provided, concluding that a performance index reflecting these attitudes should be developed in future studies.
Article Synopsis
- The study investigates the relationship between the quantity and quality of clinical trial papers published by 11 core research hospitals, showing that simply counting publications is not enough to measure research effectiveness.
- A scoring system was used to evaluate the quality of 580 surveyed papers based on their journal impact factor relative to the number of publications.
- Results indicated no significant correlation between the number of papers and their quality, suggesting that institutions should assess both quality and quantity when evaluating clinical research performance.
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.
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.
Article Synopsis
- The study aimed to evaluate how effective capecitabine and trastuzumab are in treating HER2-overexpressing metastatic breast cancer patients who are resistant to other chemotherapy drugs, specifically anthracyclines and taxanes.
- A total of 40 patients participated, and those who completed the treatment showed a median overall survival of 22.3 months and a progression-free survival of 4.1 months, with an overall response rate of 18.4%.
- The treatment was found to be effective and well-tolerated, with some manageable hematological side effects but no treatment-related deaths reported.
Suppressive effects of Perilla frutescens on IgA nephropathy in HIGA mice.
Nephrol Dial Transplant
March 2003
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.