Hitoshi Kanno

Dataset for "Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports the study entitled “Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan.” The dataset contains information extracted from publicly available review reports and related regulatory documents issued by the Pharmaceuticals and Medical Devices Agency in …

jp, us (code pays fourni par la source)

Dataset for "Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports the study entitled “Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan.” The dataset contains information extracted from publicly available review reports and related regulatory documents issued by the Pharmaceuticals and Medical Devices Agency in …

jp, us (code pays fourni par la source)

Dataset for "Linking Risk Management Plan Changes, Safety Labeling, and Regulatory Reassessment: A Safety Issue-Level Analysis of Antineoplastic Agents in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports a study examining the relationships among risk management plan changes, safety labeling, and regulatory reassessment of antineoplastic agents in Japan. The study was a retrospective observational analysis of publicly available re-examination reports and related regulatory documents published by the …

jp (code pays fourni par la source)

Dataset for "Linking Risk Management Plan Changes, Safety Labeling, and Regulatory Reassessment: A Safety Issue-Level Analysis of Antineoplastic Agents in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports a study examining the relationships among risk management plan changes, safety labeling, and regulatory reassessment of antineoplastic agents in Japan. The study was a retrospective observational analysis of publicly available re-examination reports and related regulatory documents published by the …

jp (code pays fourni par la source)

Dataset for "Linking Risk Management Plan Changes, Safety Labeling, and Regulatory Reassessment: A Safety Issue-Level Analysis of Antineoplastic Agents in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports a study examining the relationships among risk management plan changes, safety labeling, and regulatory reassessment of antineoplastic agents in Japan. The study was a retrospective observational analysis of publicly available re-examination reports and related regulatory documents published by the …

jp (code pays fourni par la source)

Dataset for "Linking Risk Management Plan Changes, Safety Labeling, and Regulatory Reassessment: A Safety Issue-Level Analysis of Antineoplastic Agents in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports a study examining the relationships among risk management plan changes, safety labeling, and regulatory reassessment of antineoplastic agents in Japan. The study was a retrospective observational analysis of publicly available re-examination reports and related regulatory documents published by the …

jp (code pays fourni par la source)

Comment on “Distribution of Splenic Arterial Flow and Segmental Spleen Volume for Partial Splenic Arterial Embolization”

Hitoshi Kanno

Arterial Embolization," presents important and insightful findings.

jp (code pays fourni par la source)

Dataset for "Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan"

Hitoshi Kanno, Kotone Matsuyama, Rei Ogawa

This dataset supports the study entitled “Traceability of Efficacy Benchmarks in Single-Arm Oncology Trials Supporting Drug Approvals in Japan.” The dataset contains information extracted from publicly available review reports and related regulatory documents issued by the Pharmaceuticals and Medical Devices Agency in …

jp, us (code pays fourni par la source)

Comment on “Usefulness of the Palliative Prognostic Index in Predicting Prognosis when Considering the Transition from Hospital to Home Care in Patients with Terminal Stage Cancer”

Hitoshi Kanno

jp (code pays fourni par la source)

Comment on “Predictive Postoperative Inflammatory Response Indicators of Infectious Complications Following Gastrectomy for Gastric Cancer”

Hitoshi Kanno

jp (code pays fourni par la source)

Analysis of Challenges to Implementation of Quality by Design: Insights from Focus Group Interviews with Researchers and Clinical Trial Professionals

Saori Hirota, Sachie Yoshida, Naoya Kamiyama, Kento Asano et autres

アカデミアで実施される臨床試験において，Quality by Design（QbD）—研究計画の初期段階から品質を組み込むことを強調する概念—の実装は，関係者の役割の多様性や組織的制約により，しばしば課題となる．本研究は，プロトコール作成および品質管理において中心的な役割を果たすアカデミア所属の研究者と臨床試験専門職（CTP）における，QbDに関連する認識と課題を明らかにすることを目的とした．両者に半構造化インタビューを実施し，得られたデータには質的テーマ分析を適用した．その結果，2つの主要な課題が明らかとなった．第一に，「質」の解釈における相違が認められた．研究者は，質を「望ましい研究成果の達成」と結び付けて捉える傾向があったのに対し，CTPは積極的な試験設計，リスクの早期特定，および継続的な品質監視の重要性を強調していた．第二に，研究者とCTPの間の協働および相互の対話は限られていた．研究者はCTPを科学的協働者というよりも事務スタッフと見なす傾向があり，CTPはプロトコール作成への主体的関与と責任感を欠いていた．これらの結果は，CTQ（Critical to Quality）要因に関する理解が不十分であり，試験初期段階における体系的な品質設計の実装が不十分であることを示唆している．QbDを効果的に実装するには，CTQ要因を初期段階から共有し，互いを専門的パートナーとして認識し，協働の枠組みを構築することが重要である．学際的な初期コミュニケーションと相互理解の促進は，科学的に厳密であり，かつ運用上実現可能な臨床試験の設計に寄与することが期待される．

jp, us (code pays fourni par la source)

Comment on “Causes and Management of Endoscopic Retrograde Cholangiopancreatography-Related Perforation: A Retrospective Study”

Hitoshi Kanno

jp (code pays fourni par la source)