APG-4000...（2） グロウジェクター Lは皮下投与以外の目的には使用しないでください。（3） グロウジェクター L、A型専用注射針及び専用製剤は他の人と
薬剤疫学の任務とその目指すもの -...
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Clin Eval 29 （1）2001 －133 － 薬剤疫学の任務とその目指すもの 貞池 哲志 前田 直子 多田 春江 浜田知久馬 福島 雅典 京都大学大学院医学研究科薬剤疫学教室 Pharmacoepidemiology mission and goal － from new drug development to health care improvement Tetsuji Sadaike, Naoko Maeda, Harue Tada, Chikuma Hamada, Masanori Fukushima Kyoto University Graduate School of Medicine & Public Health, Department of Pharmacoepidemiolgy Abstract There has been a great social demand for using appropriate drugs, practising standard treatments, and preventing adverse drug reactions. The importance of pharmacoepidemiology as a practice of clinical science is now widely recognized. Pharmacoepidemiology is a science that describes, explains, controls, and predicts the uses and effects of drugs. The risk assessment of new drugs begins early in research and development, and continues throughout their life cycle. Pharmacoepidemiology is also the art of using science and tools of science to generate information on pharmaceutical outcomes, including adverse events, in post-marketing surveillance (PMS). Today, developments and approvals for new drugs are accelerated. In the accelerated drug approval program, surrogate endpoints are used to evaluate their efficacy. Being ahead of these new medical trends, systematic PMS is the most important challenge. Therefore, collaborative surveillance by pharmaceutical companies, academia, and regulatory agencies is indispensable to prevent serious adverse reactions. Here we present several case studies as examples of the regulatory decision-making for drug safety. We evaluated the history of drug disasters and propose a countermeasure to prevent such tragedies in the future. The case study on oral thiazolidinedion antihyperglycemic agent-pioglitazon underscores the necessity of complete registration of new drug users to detect very rare adverse events, and the necessity of early regulatory decision-making to prevent its serious adverse reactions. We also discuss further pharmacoepidemological approaches based on current trends of drug discovery and development, clinical trials, and pharmacovigilance in order to improve health care outcomes. Key words pharmacoepidemiology, drug development, clinical trial, pharmacovigilance, post-marketing surveillance Rinsho Hyoka（Clinical Evaluation）2001；29：133－45. 2市販後の安全性（研究者の取組み）
Transcript of 薬剤疫学の任務とその目指すもの -...
Clin Eval 29
－133－
薬剤疫学の任務とその目指すもの
貞池 哲志 前田 直子 多田 春江 浜田知久馬 福島 雅典京都大学大学院医学研究科薬剤疫学教室
Pharmacoepidemiology mission and goal－ from new drug development to health care improvement
Tetsuji Sadaike, Naoko Maeda, Harue Tada, Chikuma Hamada, Masanori FukushimaKyoto University Graduate School of Medicine & Public Health,
Department of Pharmacoepidemiolgy
Abstract There has been a great social demand for using appropriate drugs, practising standard treatments, and preventing adverse drug reactions. The importance of pharmacoepidemiology as a practice of clinical science is now widely recognized. Pharmacoepidemiology is a science that describes, explains, controls, and predicts the uses and effects of drugs. The risk assessment of new drugs begins early in research and development, and continues throughout their life cycle. Pharmacoepidemiology is also the art of using science and tools of science to generate information on pharmaceutical outcomes, including adverse events, in post-marketing surveillance (PMS). Today, developments and approvals for new drugs are accelerated. In the accelerated drug approval program, surrogate endpoints are used to evaluate their efficacy. Being ahead of these new medical trends, systematic PMS is the most important challenge. Therefore, collaborative surveillance by pharmaceutical companies, academia, and regulatory agencies is indispensable to prevent serious adverse reactions. Here we present several case studies as examples of the regulatory decision-making for drug safety. We evaluated the history of drug disasters and propose a countermeasure to prevent such tragedies in the future. The case study on oral thiazolidinedion antihyperglycemic agent-pioglitazon underscores the necessity of complete registration of new drug users to detect very rare adverse events, and the necessity of early regulatory decision-making to prevent its serious adverse reactions. We also discuss further pharmacoepidemological approaches based on current trends of drug discovery and development, clinical trials, and pharmacovigilance in order to improve health care outcomes.
Key wordspharmacoepidemiology, drug development, clinical trial, pharmacovigilance, post-marketing surveillance
Rinsho Hyoka Clinical Evaluation 29
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臨床評価
－134－
はじめに
1. 薬剤疫学の実務（～ 2001年）
1） irinotecan hydrochloride（塩酸イリノテカン）
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Table 1 Chronological representation of recommendations to regulatory agencies, and responses by theagencies as regulatory decision-making
recommendation Response
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2） G-CSF
3） インスリン抵抗性改善薬，pioglitazone
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4） NSAIDs
5） 新変異型クロイツフェルト ヤコブ病
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2. 薬剤疫学が目指すもの－医薬品の開発から施薬までの包括的な管理
1） 医薬品開発と治療学発展の基盤
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2） 深い臨床的洞察がよい臨床試験の鍵
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3） 戦略的医薬品開発のpitfall（落とし穴）
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4） 有効性・安全性の客観的証拠とは
5） 臨床試験，その論理と意思決定の原理
Fig. 1 Pharmacovigilance network
Pharm,Co.
Academic
Government Reg.A.
Private
PatientPhysicianPharmacistNurse
情報公開：リスク予見→回避
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6） 臨床試験の基盤とは何か
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AERA
Nature
NatureNature Medicine
臨床評価
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7） 予防と早期診断へのパラダイムシフト
おわりに
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文 献
120
New Engl J Med 340
Oncologia 6
56
11
28
Nature342
Nature Medi-cine 1
