国際共同治験 バイオロジクスフォーラム 2014/12/12 富永俊義
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1 国際共同治験 バイオロジクスフォーラム 2014/12/12 富永俊義
2 歴史的経緯 ICH 開始 1997 新 GCP 施行 1998 E5ガイドライン施行 2000 治験の空洞化が問題になる (2003 治験活性化 3 年計画 2007 五カ年計画 ) 2005 ドラッグラグ問題となる / ブリッジングスタディ主流 2007 国際共同治験に関する基本的考え方について 2011 早期探索臨床研究拠点 2012 日本主導型グローバル臨床研究体制整備事業 臨床研究 治験活性化 5カ年計画 2012 ( 治験 臨床試験の質 )
3 外国臨床データを受け入れる際に考慮すべき民族的要因について (ICH E5Gl) 欧米で承認取得に足りる臨床データ 国内で 吸収 分布 代謝 排泄 投与量設定に関する試験 比較臨床試験 1985 年以来要求 ( 局長通知 ) 1998 年に E5Gl に基づき新通知 欧米で承認取得に足りる臨床データ 国内で PK ブリッジング試験 ブリッジング試験 : 外国臨床データを新地域に外挿できるかどうかを評価するために必要な追加データのみを求める 3
4 E5 Implementation Working Group Questions & Answers (R1) (2006) Q11 ( 部分 ) It may be desirable in certain situations to achieve the goal of bridging by conducting a multi-regional trial under a common protocol that includes sufficient numbers of patients from each of multiple regions to reach a conclusion about the effect of the drug in all regions. Please provide points to consider in designing, analyzing and evaluating such a multi regional trial. A11( 部分 ) For a multi regional trial to serve as a bridging study for a particular region, it would need to have persuasive results in that region, because it is these regional results that can convince the regulators in that region that the drug is effective, and can "bridge" the results of trials in other regions in the registration application.
5 初回届出数 新 GCP 公布 722 E 治験届数 ( 医薬品 ) 初回治験届出数治験届出数 治験の空洞化 治験届出数
6 2000 年代前半 MRCT が急増 政策研ニュース 2008 年 12 月
7 韓国の MRCT の伸び
8 日本で承認される医薬品の根拠となった Global 治験の増加 Number of Approved Drugs Total Bridging GCT % of Bridging % of GCT % 0 FY2007 FY2008 FY2009 FY2010 FY2011 FY2012 FY2013 Year 0 8
9
10 MRCT に関する話題 民族差 開発戦略 ICH E17 ガイドライン 大阪市大病院での経験 日本の施設の MRCT における競争力
11 国際共同治験に関する基本的考え方について (2007) 総合科学技術会議報告書 科学技術の振興及び成果の社会への還元に向けた制度改革について ( 平成 18 年 12 月 ) においては 新規医薬品開発の効率化 迅速化の観点から外国との国際共同治験を推進すべき旨指摘しており また 厚生労働大臣の検討会報告書 有効で安全な医薬品を迅速に提供するための検討会報告書 ( 平成 19 年 7 月 ) においては ドラッグ ラグ ( 欧米で承認されている医薬品が我が国では未承認であって国民に提供されない状況 ) 解消のためには 国際共同治験の推進を図る必要があり 承認審査の観点から必要な国際共同治験実施に当たっての基本的考え方を明らかにする必要がある旨 指摘している
12 国際共同治験に関する基本的考え方について (2007) 方法 1 においては 全体の症例数の増加を適度に抑制しながら日本人症例数を最小としようとする場合 およそ 20 % の症例を確保することが必要になる また 方法 2 の場合には 全集団での検出力を 90 % として 3 地域で実施するのであれば 日本人症例数としておよそ 15 % 以上を確保することが必要になる 国際共同治験に関する基本的考え方 ( 参考事例 )(2012) 致死的でない疾患に対して長期投与が想定される医薬品については 十分に長期投与時の安全性を確認する必要があり 基本的には日本人で 1 年間投与された症例として 100 例程度以上の安全性データが収集できるよう計画すべきである なお これら事例は 現時点における科学的知見に基づいて述べたものであり 今後の状況の変化 科学技術の進歩や知見の集積等に応じて随時見直され 改訂されるべきものである 12
13 Clin Pharmacol Ther 94: , (2013 August)
14 Ethnic Difference FDA found Effective (mortality lowered) in ALL and non US pop ns, but not in US subjects, constituting 25% of total.
15 Similar views b/w USFDA & PMDA Accumulating more scientific data on ethnic factors may clear the way for international harmonization of these efforts (regulatory standards regarding GCT data) PMDA Much additional work is needed to improve the design and conduct of MRCT, as well as the assessment and analyses of data from MRCT. FDA Regulatory challenges in the Review of Data from Global Clinical Trials: the PMDA Perspective Regulatory and Scientific Issues Regarding Use of Foreign Data in Support of New Drug Applications in the United Stated: An FDA Perspective Clin Pharmacol Ther 94: , (2013 August)
16 Kristina Dunder MD, PhD Medical Products Agency, Sweden Kitasato Harvard Symposium 2009
17 Yoshiaki Uyama, PMDA, DIA Annual Conference (2012)
18 Yoshiaki Uyama, PMDA, DIA Annual Conference (2012)
19 Yoshiaki Uyama, PMDA, DIA Annual Conference (2012)
20 Frequencies of mutation by background Asian, non smoking females adenocarcinoma Japan Lung Cancer Society: On EGFR mutation test for lung cancer patients (2009) Mitsudomi T, Yatabe Y. Cancer Sci 2007;98:
21 Efficacy and the locus of mutation EGFR Gene Frequency Efficacy (%) Japan Lung Cancer Society Guideline, Mitsudomi T, Yatabe Y. Cancer Sci 2007;98:
22 MRCT と医薬品開発戦略
23 医薬品の日米欧同時開発の傾向 (1) 1. 従来 P I P II P III Phase IV 海外日本 or Non clinical Non clinical P I Review P bridge II P I P II P Review III Review Phase IV Phase IV 2. 最近 海外 日本 global P I P II P III Phase IV P I P II join Review Review Phase IV 23 河野典厚日本製薬工業協会シンポジウム2012
24 医薬品の日米欧同時開発の傾向 (2) 3. 今後?! FIH 試験を国際共同で実施する時代に?! Phase I Phase II 海外 日本 Non clinical Phase I Global Phase II Phase II Review Review Phase IV Phase IV 国際共同治験に関する基本的考え方について ( 平成 19 年 9 月 28 日薬食審査発第 号 ) Q2: 日本はいつからグローバル開発に参加すべきか? A2: 世界的に進行している臨床開発について できるだけ早期に参加することが望ましい このため 遅くとも用量反応性を探索的に検討する段階の試験から参加できるよう予め検討しておくことが重要である 24 河野典厚日本製薬工業協会シンポジウム 2012
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26 Local Global Clinical Trial and Drug Lag Bridging Global CT Ueno T et al. Clin Pharmacol Ther
27 E17: General principle on planning/designing Multi Regional Clinical Trials (Nov ) Issues to be Resolved Issues in planning MRCTs Usefulness of MRCTs in drug developments Essential points for conducting MRCTs (GCP etc) Importance of ethnic factors evaluation on drug efficacy/safety in MRCTs etc. Issues in designing MRCTs Points to consider in dose determination for MRCT (exploratory and confirmatory) How to control various concomitant medications in each country Consideration on definition of a population and methods of sample size estimation for a population/region etc. Others Encouraging a parallel scientific consultation with multiple regulatory agencies in advance
28 バイオ医薬品と MRCT ケミカル医薬品とバイオ医薬品のMRCT( の必要性など ) の差? 承認されたバイオ医薬品においてMRCTを行っている割合は ケミカル医薬品と比べて高いか低いか? データはないのですが 臨床開発のモードとして MRCT を採用するかどうかは 抗体薬はターゲットが狭いので MRCT をやらないと症例数が集まらない といった事情で決まる話で バイオだからか ケミカルだからか で決まるものではないようです
29 Recently approved oncology drugs using multi national clinical data package including Japanese patient FY name CT design Target 2012 Proportion of Japanese in CT database regorafenib RCT Colon & rectal cancer 13% ofatumumab SAT CLL 90% paclitaxel proteinbound particles for RCT NSCLC 14% injectable suspension everolimus RCT nodular sclerosis 9% pazopanib RCT soft part sarcoma 13% Axitinib RCT renal cancer 7% xalkori SAT NSCLC 13% 2011 denosumab RCT Breast cancer 7% Dasatinib RCT CML 10% Our experience will be contributed to East Asian drug review In particular, for Asian specific diseases, e.g. stomach cancer, ATL, HCC,. 29
30 阪市 治験センターでの経験など
31 新規治験受託内訳 ( 件 ) 年度 21 年度 22 年度 23 年度 24 年度 10 月末時点 初回治験計画届件数のうち国際共同治験関係 平成 20 年度平成 21 年度平成 22 年度平成 23 年度平成 24 年度平成 25 年度 国内治験 国際共同治験 医師主導治験 n 回治験計画届件数のうち国際共同治験関係 治験計画届出件数全数 ( 初回 +n 回 ) に占める国際共同治験に係る届出の割合 (%) 日本平均は 23% 阪市 学医学部附属病院 2014/05/20
32 ( 国内治験に比べて )MRCT が実施施設 ( 治験コーディネーター (CRC)) にとってしんどいこと 1. 準備が多い 紙の量が多い バインダーが厚い 2. 日本での実施者 ( 多国籍製薬会社日本支社 CRO) が いちいちグローバ ルHQsに伺いを立てるので 問い合わせ一つとっても時間がかかる 3. 被験者登録を世界規模で運用されるウエブサイトで行う これの使い勝手 が一般に悪く 面倒 4. 原資料に求められるクオリティが厳密である 5. 特に提出しなければならないMonitoring Visit Log Training Logが多い 6. 他国の症例で目標症例数に達した場合には 症例登録が打ち切られる 7. 英語での報告 疑義照会等が面倒
33 日本の治験 ( 施設 ) の MRCT に関する競争力
34 国際共同治験 Phase Ⅱ 進捗状況 ( 自社データー ) (accumulated) 最終割付症例数 : 中国 投与期間 : 2 年 Key Open 2013 年 9 月 韓国 日本 大冢制药研发 ( 北京 ) 有限公司満志偉第 33 回臨床薬理学会学術総会
35 1 施設当たり症例数 ( 第 2,3 相 ) ( ) NMEs Median 6.57 (n=174) 頻度 大阪市大病院実施症例数 ( 件 ) 次の級 データ区間 頻度 JPMA 政策研ニュース No. 36 (2012)
36 日本の治験データの 質 の高さ Placebo Drop Outs JP vs US Good Compliance to Protocol Good Management Teshirogi, Kitasato Harvard Symposium (2011) Business performance data derived from Novartis Oncology global clinical trials Japan Japan Uden, Kitasato Harvard Symposium (2011)
37 医療機関の治験費用の現状 JPMA News Letter No.143(2011/05)
38 Risk based Definition (Ann Meeker O Connell, 元 FDA 査察官 ) 日本のセールスポイントの治験データの質の再定義とその追求が鍵ではないかと思います
39 ご静聴ありがとうございました
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PMDA 国際共同治験ワークショップ 国際共同治験 ~ 医薬品開発において日本ができること ~ 国際共同治験開始前の日本人での第 Ⅰ 相試験の実施に関する基本的考え方について 概要と留意点について 浅野邦仁 ( 独 ) 医薬品医療機器総合機構新薬審査第一部国際共同治験プロジェクトチーム (PMDA) 1 本日の内容 国際共同治験の現状とこれまでに発出された国際共同治験に関する通知について 国際共同治験に関する基本的考え方について
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