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1 8th Kitasato University- Harvard School of Public Health Symposium on Advanced and Global Drug Development Techniques "Learning from Experience and New Challenges for the Future" Tuesday, September 30, 2008 ANA Intercontinental Tokyo, Room "Prominence" Global Clinical Trials of Medical Devices -Complementary Approach with Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD)- 医療機器治験における国際協調体制 -GHTF と HBD イニシアチブ - Kazuhiro Sase, M.D., Ph.D Clinical Pharmacology, Juntendo University 順天堂大学臨床薬理学 佐瀬 一洋 sase@skyblue.ocn.ne.jp Juntendo University. All rights reserved. Unauthorized use prohibited.

2 Global Clinical Trials of Medical Devices - Complementary Approach with Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD) - Clinical Evaluation of Medical Devices GHTF Global Harmonization Task Force HBD Harmonization by Doing Juntendo University Medical School 2 8th Kitasato University - Harvard School of Public Health Symposium, September 30, 2008, Tokyo, Japan

3 Implantable Cardiac Defibrillator Amiodarone or an Implantable Cardioverter- Defibrillator for Congestive Heart Failure (SCD-HeFT) G.H. Bardy and others (N Engl J Med 2005; 352 : ) ) Bardy GH. N Engl J Med. 2005;352:

4 Global Clinical Trials of Medical Devices - Complementary Approach with Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD) - Clinical Evaluation of Medical Devices GHTF Global Harmonization Task Force HBD Harmonization by Doing Juntendo University Medical School 4 8th Kitasato University - Harvard School of Public Health Symposium, September 30, 2008, Tokyo, Japan

5 GHTF Classes Class A Overview of PAL Regulation Risk-based Classification Extremely Low Risk (X-Ray films) - Pre-Market Phase - Pharm. Affairs Law. Class Mkt. Auth. General NA NA Sales QMS Class B Class C Class D Low Risk (MRI, digestive catheters) Medium Risk (artificial bones, dialyzer) High Risk (pacemaker, heart valve, VAS, ICD) Controlled Specially Controlled 3rd. Party Certificatio n MHLW s Approval Registration* License (Pre- fecture) Inspe ection * Some exception

6 Diversity in the Regulation and Approval of Medical Devices Japan: PAL & ICH-GCP MHLW/PMDA Clinical Trial Notification Pre-Market Approval Orphan Device US: Common Rules (45CFR46) FDA (Food and Drug Administration) IDE: Investigational Device Exemption PMA: Pre-Market Approval 510k Compassionate Use Early Consultation EU: ISO (Clinical investigation of medical devices for human subjects) Conformity Assessment Body CE-Marking

7 Global Harmonization Task Force (GHTF) Steering Committee Study Group 1 Regulatory systems Pre-market assessment Essential Principles i Study Group 2 Vigilance reporting Market surveillance Study Group 3 Quality system requirements Study Group 4 Quality systems auditing Study Group 5 Clinical evaluation, Clinical Evidence In-vitro Diagnosis

8 Global Clinical Trials of Medical Devices - Complementary Approach with Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD) - Clinical Evaluation of Medical Devices GHTF Global Harmonization Task Force HBD Harmonization by Doing Juntendo University Medical School 8 8th Kitasato University - Harvard School of Public Health Symposium, September 30, 2008, Tokyo, Japan

9 HBD: 実践と調和 Coordinating Government, Industry, and Academia. All for Patients. 国際整合化会議 Global Harmonization Task Force DSMB バイアス bias 完全性 integrity 遵守 compliance 治験依頼者 SPONSOR スピード speed コスト cost 質 quality 規制当局 (PMDA, FDA) REGULATORY AUTHORITY 個人国世界 individual national global 患者さん共通の言葉は Patients? Common 痛み Pain Language? 苦しみ Discomfort 良く生きたい QOL 長く生きたい Survival 治験責任医師 INVESTIGATOR 診療教育研究 治験 Clinical Investigation 市販後報告 Post Marketing Surveillance 治療ガイドラインTreatment Guideline / Quality Initiative 実践と調和 Harmonization By Doing practice education research IRB 科学倫理信頼 science ethics quality

10 FDA Think-Tank T k (March 28, 2005 in Washington D.C.) 10 Hot Topics in Devices Impact of the Critical Path Initiative Drug Eluting Stents Distal Protection Devices Percutaneous Valves Global Perspectives on Harmonization Pre- and Post-Market Device Evaluation International Pre-Market Evaluation International Post-Market Evaluation Juntendo University Medical School

11 日本における HBD Think Tank と Town Hall Meeting 2004 年 4 月日本循環器学会 2004 年 9 月京都 JACCT 2004 総会 2005 年 2 月倉敷ライブ 2005 倉敷 2005 年 4 月小倉ライブ小倉 2005 年 6 月 JSIC 2005 総会東京 2005 年 8 月 JACCT 2005 総会岐阜 2005 年 12 月 JCA 2005 総会大阪 2005 年 12 月 HBDシンクタンク東京 ( 非公開 ) 開催 2007 年 1 月第 1 回 HBD 公開シンクタンク ( 米国 ) 2008 年 7 月第 2 回 HBD 公開シンクタンク ( 日本 ) Juntendo University Medical School 11

12 (3) Harmonization by Doing Japanese Circulation Society - April 2004 Japanese Coronary Association - December 2005 Think Tank in Tokyo - December 2005 FDA, MHLW, Japanese academia discuss scientific concerns and regulatory issues July 2006 Steering Committee Initial Working Groups Review by FDA and MHLW FDA MHLW/PMDA DCRI Guidance/Suggestion JAG AdvaMed JFMDA 1. Global Cardiovascular Device Trials Report/Request 2. Study on Post Market Registry (Artificial Heart) 3. Clinical Trials Infrastructure/ Methodology 4. Regulatory Convergence/Communication 12

13 Harmonization by Doing (HBD) Parallel development, application, submission i and review Developing clinical infrastructure for the simultaneous/parallel clinical trials in US and JP Those actions are for the aim of HBD, that is... Parallel approval and access to brand-new medical devices for US/JP patients t benefit!

14 Harmonization Byy Doing (HBD) プロジェクトの推進 - 日本と米国の患者さんのために - 米国 FDA との協力 連携による審査の迅速化 日米規制当局間の交流 情報交換を活性化させ 医療上のニーズの高い医療機器について 国際共同治験を推進するとともに 密接な情報交換のもとに協力して審査を実施する体制を構築し 効率的かつ迅速な審査を進めるための施策の検討を行い 医療機器の承認におけるタイムラグの改善を図る 米国 FDAとの心臓血管系領域の医療機器を事例として 意見交換を進めている Juntendo University Medical School 14

15 (1) INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support NHLBI Contract #HHSN C Prospective NIH funded registry Provides Enhanced Surveillance: AEs, Device Malfunctions QOL Survival Develops clinical Best Practices (reducing complications) Provides means for designing i & conducting postapproval studies in cost efficient way Allows manufacturers to obtain data from INTERMACs to fulfill post-market requirements 15

16 (2)-3 Next-Generation Medical Devices project FY Inter-agency Committee for the Guideline Development MHLW NIHS National Institute of Health Sciences METI AIST National Institute of Advanced Industrial Science and Technology Navigation Surgery WG Drug Delivery System WG Prosthetic Implants WG Active Implants WG Regenerative Medicine WG Japan Society for Thoracic Surgery Japan Society for Artificial Organs

17 HBD-WG2 Early Discussions July 2006 FDA encourages INTERMACS to begin discussions with Japan on collecting Japanese post-market MCSD data October 2006 MHLW and Japanese academia visit INTERMACs headquarters at UAB October 2006 Working Group 2 (Industry, Regulators, and Academia) discuss the potential of INTERMACs January 2007 HBDW West tthink ktank October 2007 Japanese Society of Artificial Organs (1) INTERMACS July 22, 2008 (3) HBD (2) Japanese PMS LVAS Registry Next-Generation ti MDs WG2 17

18 Accomplishments Safety Division of PMDA has decided to support activities to develop a Japanese version of INTERMACS to collect, analyze, and provide information pertaining to post-market safety of MCSDs set up a steering committee and a working group to discuss the issues in detail July 22,

19 Development of a system to collect and evaluate data for medical devices that require tracking (Draft) (Provisional Translation) Contributions to Safety Measures Incorporated Administrative Agency - Pharmaceuticals and Medical Devices Agency (PMDA) Midterm Plan No2. 2 (2) d. For high-risk implantable medical devices that require tracking, such as pacemakers, the Agency, by the end of the Midterm Targets period, shall develop a system to collect and evaluate data regarding the operational status of medical devices as well as failure rates over time. Steering committee PMDA PMDA s committee Report Working Group Advise DB International registry Cooperation Academic Societies Japanese Society for Artificial Organs Japanese Association for Clinical Ventricular Assist Systems The Japanese Association for Thoracic Surgery The Japanese Society of Cardiovascular Surgery The Japanese Circulation Society The Japanese Heart Failure Society The Japanese College of Cardiology Case Report s on Med ical device ma alfunctions Data Industries Access Report Contract Data coordinating center DB (Japanese Registry for VAD) Project manager, Data manager Biostatistician, Monitor etc. Data access (own company s) Investigation Information Data access (own site s) Harmonization by Doing (HBD)-US Registry (Japan -US) (INTERMACS) International INTERMACS ISHLT:MCSD ISHLT Registry Hospital Enrollment Follow-up (Data entry) Participating institutions Hospital Hospital Local principal Investigator, Site administrator, CRC etc.

20 Next steps Develop the protocol for the Japanese registry Discuss with safety division of PMDA to decide on data fields that should be capture by the Japanese registry Discuss the structure and interface of the Japanese registry Discuss dataset structure, programs for data extraction ti and analysis Ensure that the requirements for post-market studies in Japan are established Discuss how data can be used globally with INTERMACS INTERMACS July 22,

21 Strategy of HBD Doing is Key! On the Job Training on Projects Proof-of-Concept Projects Achievable Steps Build on Success Additional Sites Multiple Projects Drugs and Devices Other Therapeutic Areas

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24 Global Clinical Trials of Medical Devices - Complementary Approach with Global Harmonization Task Force (GHTF) and Harmonization by Doing (HBD) - Clinical Evaluation of Medical Devices GHTF Global Harmonization Task Force HBD Harmonization by Doing Juntendo University Medical School 24 8th Kitasato University - Harvard School of Public Health Symposium, September 30, 2008, Tokyo, Japan