ghtfと hbdイニシアチブ · 2008-10-23 · drug eluting stents distal protection devices...

8th Kitasato University-Harvard School of Public Health

Symposium on Advanced and GlobalSymposium on Advanced and GlobalDrug Development Techniques

"Learning from Experience and New Challenges for the Future"Tuesday September 30 2008

Global Clinical Trials of Medical DevicesGlobal Clinical Trials of Medical Devices

Tuesday, September 30, 2008ANA Intercontinental Tokyo, Room "Prominence"

Global Clinical Trials of Medical DevicesGlobal Clinical Trials of Medical Devices--Complementary Approach with Global Harmonization Task Force (GHTF) Complementary Approach with Global Harmonization Task Force (GHTF)

and Harmonization by Doing (HBD)and Harmonization by Doing (HBD)--

医療機器治験における国際協調体制医療機器治験における国際協調体制医療機器治験における国際協調体制医療機器治験における国際協調体制－－GHTFGHTFととHBDHBDイニシアチブ－イニシアチブ－GHTFGHTFととHBDHBDイニシアチブイニシアチブ

Kazuhiro Sase, M.D., Ph.D Clinical Pharmacology Juntendo UniversityClinical Pharmacology, Juntendo University

順天堂大学臨床薬理学

佐瀬一洋佐瀬洋[email protected]

© 2007-8 Juntendo University. All rights reserved. Unauthorized use prohibited.

Global Clinical Trials of Medical DevicesGlobal Clinical Trials of Medical Devices-- Complementary Approach with Global Harmonization Task Force (GHTF) Complementary Approach with Global Harmonization Task Force (GHTF)

and Harmonization by Doing (HBD) and Harmonization by Doing (HBD) --

¤ Clinical Evaluation of Medical DevicesGHTF¤ GHTFGlobal Harmonization Task ForceGlobal Harmonization Task Force

¤ HBDHBDHarmonization by Doing

Juntendo University Medical School 2

8th Kitasato University - Harvard School of Public Health Symposium, September 30, 2008, Tokyo, Japan

Implantable Cardiac DefibrillatorImplantable Cardiac DefibrillatorAmiodarone or an Implantable Cardioverter-pDefibrillator for Congestive Heart Failure (SCD-HeFT)G.H. Bardy and others（N Engl J Med 2005; 352 : 225 - 37.）（ g ; ）

Bardy GH. N Engl J Med. 2005;352:225-237.

Overview of PAL RegulationP M k t Ph

GHTF Classes

Risk-based Classification

Pharm. Affairs Law. QMS- Pre-Market Phase -

Classes ClassificationClass Mkt.

Auth.Sales

Class A Extremely Low Risk(X-Ray films)

General NA NA

Class B Low Risk (MRI, digestive catheters)

Controlled 3rd. Party Certification

Regist-ration* Inspe

Class C Medium Risk(artificial bones, dialyzer)

Specially Controlled

MHLW’s Approval

License(Pre-fecture)

ection

dialyzer) fecture)Class D High Risk

(pacemaker, heart valve, VAS, ICD)

* Some exception

Diversity in the Regulation and A l f M di l D iApproval of Medical DevicesJapan: PAL & ICH-GCP

MHLW/PMDAClinical Trial NotificationPre-Market ApprovalPre Market ApprovalOrphan Device

US: Common Rules (45CFR46)

FDA (Food and Drug Administration)IDE: Investigational Device ExemptionPMA: Pre-Market Approvalpp510k Compassionate Use

Early ConsultationEarly ConsultationEU: ISO-14155 (Clinical investigation of medical devices for human subjects)

Conformity Assessment BodyConformity Assessment BodyCE-Marking

Global Harmonization Task Force (GHTF)

Steering CommitteeStudy Group 1Study Group 1

Regulatory systemsPre-market assessment

i i iEssential PrinciplesStudy Group 2

Vigilance reporting

www.ghtf.orgVigilance reportingMarket surveillance

Study Group 3Quality system requirementsQuality system requirements

Study Group 4Quality systems auditing

Study Group 5Clinical evaluation, Clinical EvidenceEvidenceIn-vitro Diagnosis

HBD: HBD: 実践と調和実践と調和Coordinating Government, Industry, and Academia. All for Patients.Coordinating Government, Industry, and Academia. All for Patients.

規制当局（PMDA, FDA)REGULATORY AUTHORITY

国際整合化会議実践と調和

REGULATORY AUTHORITY個人 individual国 national世界 global

共通の言葉は？Common

国際整合化会議Global HarmonizationTaskForce

実践と調和HarmonizationBy Doing

患者さんPatientsCommon Language ?

DSMB治験依頼者SPONSOR

痛み Pain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 IRB

治験

DSMBバイアス bias完全性 integrity遵守 compliance

スピード speedコスト cost質 quality

診療 practice教育 education研究 research

IRB科学 science倫理 ethics信頼 quality

治験 Clinical Investigation市販後報告 Post Marketing Surveillance治療ガイドラインTreatment Guideline / Quality Initiative

FDA Thi k T k S iFDA Think-Tank Session@CRT2005 (March 28, 2005 in Washington D.C.)

Hot Topics in DevicesImpact of the Critical Path Initiative

Drug Eluting StentsDistal Protection DevicesPercutaneous Valves

Global Perspectives on Harmonization

Pre- and Post-Market Device EvaluationInternational Pre-Market Evaluation

Juntendo University Medical School10International Post-Market Evaluation

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 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）• 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

(3) Harmonization by Doing(3) Harmonization by Doing• Japanese Circulation Society - April 2004

J C A i ti D b 2005• Japanese Coronary Association - December 2005• Think Tank in Tokyo - December 2005• FDA, MHLW, Japanese academia discuss scientific

concerns and regulatory issues – July 2006

Review by FDA and MHLW

FDA MHLW/PMDA DCRISteering

C i JAG AdvaMed JFMDAFDA MHLW/PMDA DCRICommittee

1 Global Cardiovascular Device TrialsGuidance/Suggestion Report/Request

JAG AdvaMed JFMDA

1. Global Cardiovascular Device Trials2. Study on Post Market Registry (Artificial Heart)

3. Clinical Trials Infrastructure/ Methodology

Initial WorkingGroups

124. Regulatory Convergence/Communication

Harmonization by Doing (HBD)Parallel development, application,

i i isubmission and reviewDeveloping clinical infrastructure for the simultaneous/parallel clinical trials in US and JP

Those actions are for the aim of HBD, that is...a s...

Parallel approval and access to brand-new di l d i f US/JP ti t b fit !medical devices for US/JP patients benefit !

「Harmonization Bｙ Doing」ｙ g（HBD）プロジェクトの推進

日本と米国の患者さんのために－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、密情報換も協審施体構築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。


交換を進めてる。

(1) INTERMACS( )Interagency Registry for Mechanically Assisted Circulatory Support

NHLBI Contract #HHSN268200548198C www.intermacs.org

• Prospective NIH funded registryP id E h d S ill• Provides Enhanced Surveillance:• AEs, Device Malfunctions

QOL• QOL• Survival

Develops clinical “Best Practices” (reducing• Develops clinical Best Practices (reducing complications)P id f d i i & d ti t• Provides means for designing & conducting post-approval studies in cost efficient wayAll f t t bt i d t f

15

• Allows manufacturers to obtain data from INTERMACs to fulfill post-market requirements

(2)-3 “Next-Generation Medical Devices project” ( ) p jFY2005-2007

Inter-agency Committee for the Guideline Development

METIMHLW

NIHS AIST

METIMHLW

National Institute of Health Sciences

National Institute of Advanced Industrial

Science and Technology

Active Implants WG

Navigation Surgery WG

Drug Delivery System WG

Prosthetic Implants WG

Regenerative Medicine WG

Japan Society for Artificial Organs

Japan Society for Thoracic Surgery

HBD-WG2 Early Discussions• July 2006

– FDA encourages INTERMACS to begin discussions with Japan on collecting Japanese post market MCSD dataJapan 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)Working Group 2 (Industry, Regulators, and Academia) discuss the potential of INTERMACs

• January 2007HBD W t Thi k T k– HBD West Think Tank

• October 2007– Japanese Society of Artificial Organs p y g

(1) INTERMACS(2) Japanese PMS

LVAS RegistryN t G ti MD

July 22, 200817

Next-Generation MDs(3) HBD WG2

AccomplishmentsAccomplishments

• Safety Division of PMDA has – decided to support activities to develop a pp p

Japanese version of INTERMACS to collect, analyze, and provide information pertaining to y , p p gpost-market safety of MCSDs

– set up a steering committee and a workingset up a steering committee and a working group to discuss the issues in detail

July 22, 2008 18

Development of a system to collect and evaluate data for medical devices that require tracking (Draft) (Provisional Translation）

Incorporated Administrative Agency - Pharmaceuticals and Medical Devices Agency (PMDA) Midterm Plan h // d j / li h/ b / df/ k ik k dfhttp://www.pmda.go.jp/english/about/pdf/e-keikaku.pdf

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.

PMDAContributions to Safety

DB

PMDA’s committeeReport Advise

Measures Steering committee

International registryWorking Group

Contract

Med Report

AccessCooperation

・Harmonization by Doing (HBD)－US Registry（Japan －US）（INTERMACS）

International INTERMACS・ISHLT：MCSD →→ ISHLT Registry

Data coordinating center

Japanese Society for Artificial OrgansJapanese Association for Clinical

Case R

eportical device m

a

Academic Societies

DB(Japanese Registry for VAD） Enrollment

Follow-upProject manager,D

Japanese Association for Clinical Ventricular Assist Systems

The Japanese Association for Thoracic SurgeryThe Japanese Society of Cardiovascular Surgery

The Japanese Circulation SocietyThe Japanese Heart Failure Society

s on alfunctions

Data p（Data entry）

Participating institutions

Data managerBiostatistician, Monitor etc.

Industries

The Japanese College of Cardiology

Data access(own company’s)

Data

Investigation

Data access(own site’s)

HospitalHospitalHospital …IndustriesInformation

Local principal Investigator, Site administrator, CRC etc.

Next stepsNext 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 J i tJapanese registry

• Discuss the structure and interface of the J i tJapanese registry

• Discuss dataset structure, programs for data t ti d l iextraction and analysis

• Ensure that the requirements for post-market t di i J t bli h dstudies in Japan are established

• Discuss how data can be used globally with INTERMACS

July 22, 2008 20INTERMACS

Strategy of HBDDoing is Key!

On the Job Training on ProjectsOn the Job Training on ProjectsProof-of-Concept ProjectsAchievable Steps

Build on SuccessAdditional SitesMultiple ProjectsMultiple ProjectsDrugs and DevicesOther Therapeutic AreasOther Therapeutic Areas

ghtfと hbdイニシアチブ · 2008-10-23 · drug eluting stents distal protection devices...

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