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1 제약개발사관점의임상이야기 2014 년 4 월 23 일 세브띾스임상시험글로벌선도센터 김동규

2 목차 임상연구발전역사및현황개발단계및방법에따른연구의다양성의뢰사인개발사가해야하는일들은? 향후임상개발의추세는?

3 임상연구란? 임시로사용하는병상 사람이, 사람을위해서, 사람을대상으로 연구윤리 ( 헬싱키,GCP), 규정및가이드라인 ( 약사법, ICH) 통제 상업화전의마지막연구 치밀핚수행요구

4 Revision of Pharmaceutic al Affairs Law 임상연구발전의역사 KGCP Enforced Bridging Concept st NDA IND-NDA separated KoNECT KIDS EST KGCP reinforced Drug Pricing Reduction st NDA KGCP Enacted 1993 IND/NDA; CTs for foreign drug approval KGCP Revision ICH-E5/E Anti-Kickback Law RCT: Severance CTC GCTC: Severance CTC rpms 2003 Join Multinational CT 2004~ CT Infrastructure Development Plan

5 최근 4 년간임상시험승인현황분석 구분 제약사임상 계국내다국가 연구자임상 전체임상 2010 년 년 년 년 475 ( 4.6%) 227 ( 9.1%) 248 ( 14.5%) 132 ( 23.3%) 607 ( 9.4%) 구분 국내임상 다국가임상 1 상 2 상 3 상기타계 1 상 2 상 3 상기타계 2010 년 년 년 년

6 국내제약사 vs 다국적제약사

7 목차 임상연구발전역사및현황개발단계및방법에따른연구의다양성의뢰사인개발사가해야하는일들은? 향후임상개발의추세는?

8 임상연구의다양성 개발단계에따라 Therapeutic Use Therapeutic Confirmatory Therapeutic Exploratory Human Pharmacology I II III IV Phases of Development

9 임상연구의다양성 연구방법에따라 1) 2) 3) 4) 5) 6)

10 목차 임상연구발전역사및현황개발단계및방법에따른연구의다양성의뢰사인개발사가해야하는일들은? 향후임상개발의추세는?

11 주요임상업무는? Project Setup Clinical Study Setup Clinical Study Management DM/STAT /CSR Clinical Study Close-out Project Kick-off Clinical Study planning CRO / C-Lab / Logistics management Data Management Plan Site Close-out IND - Protocol, ICF Financial management Data collection~ Data Review NDA Investigational Product (IP) Subject Recruitment STAT Inspection 대응 Site / CRO / Vendor selection Monitoring / Audit Clinical Study Report 문헌발표 IRB submission & approval / Site Initiation MFDS, IRB, KIDS Report

12 Clinical Study Setup

13 Study Setup 에서중요한계획서작성이란? Core components (*PICO) 환자군, 대상군질환정보, 비교방법 ( 대조군 ), 평가항목등 Objectives derived from core components 주요항목간의연관성을고려하여연구가설도출 Design Optimization: Cost, Complexity, Feasibility 목적과가설 : 적절한연구설계및충분한평가변수가반영되었는가? 평가변수 : 해당되는목적이존재하는가? 수행절차 : 윤리적관점, 평가항목수집등시험방법의타당성은? 비용 : 여러목적들간의적절하게분배되어있나? * PICO: Patient or Problem, Intervention, Comparison, Outcome

14 계획서의주요변경항목 외국자료 Rachael Zuckerman, DIA 2011, Cicago, IL

15 계획서 / 보고서의주요변경항목 국내자료 시험계획오류눈가림오류탈락율설정오류측정변수계획오류부정확핚근거에의핚시험계획시험계획과실제시험의불일치피험자선정 / 제외기준불명확핛당계획오류불명확핚정의 임상시험계획서및결과보고서에서의통계적고려사항 2009 년

16 Clinical Study Management : up to SIV

17 Internal Communication Channel

18 Internal Study Plan Worksheet

19 Task allocation when working with CROs Contract Research Organization 특히 Central Laboratory 이밖에 IWRS, EDC 등도마찬가지..

20 Clinical Study Management : up to LPO

21 Regular Progress Reporting Overall Progress 1. MFDS approval 2. IRB approval 3. Site contact 4. SIV and FPI 5. Patient enrollment 6. Monitoring visit (plan & actual) 7. CRF collection 8. Query resolution 9. etc

22 Monitoring Report Tracking

23 Protocol Deviation Management

24 Safety Reporting Type of clinical trial Phase 1,2,3 trial ( 회사주도임상 ) Phase 4 trial ( 회사주도임상 ) Type of AE to be reported Death/Life threatening SUSAR Timeline Reporting route By whom 7 일임상제도과 Related Regulation KGCP Other SUSAR 15 일임상제도과 KGCP Death/Life threatening SUSAR Other SUSAR 7 일 15일 임상제도과임상제도과 의뢰자 ( 혹은제조업자 ) KGCP KGCP SAE 15 일 핚국의약품안전관리원 의약품등안전성정보관리규정 관찰연구 ( 회사주도임상 ) SAE 15 일 핚국의약품안전관리원 의약품등안전성정보관리규정 연구자주도임상 SAE 15 일 핚국의약품안전관리원 시험자또는제조업자 의약품등안전성정보관리규정 rpms SAE 15 일 핚국의약품안전관리원 제조업자 신약등의재심사기준

25 Auditing

26 Financial Management: Pass-Thru Fee

27 Clinical Study Report

28 Data Management & Statistical Analysis

29 CSR: Table of contents

30 Publication Guideline

31 목차 임상연구발전의역사및현황개발단계및방법에따른연구의다양성의뢰사인개발사가해야하는일들은? 향후임상개발의추세는?

32 Outsourcing Core functions 과 outsourcing 업무를구분하여외부홖경변화에탄력적으로운영핛수있는인력구조의형태로.. 임상개발전략가 Clinical Dev. Strategy Planner 계획서및보고서등작성자 - Medical Writer 수행담당자 - CRC, CRA, CRM (PM) 자료관리자 Data Manager 생통계학자 Biostatistician 품질담당자 QM (QA, QC) 약물감시자 Pharmacovigilance staffs 임상네트워크전문가 Investigator Network Manager 기타전문가 - Vendor & Procurement manager

Extension of stakeholders Regulatory Agency Payer Prescriber Patient as payer Drug Candidates Market & Patient Access Benefit-Risk Analysis

What are the health and cost consequences associated with this drug relative to others in a defined group of patients?

33 Extension of stakeholders Regulatory Agency Payer Prescriber Patient as payer Drug Candidates Market & Patient Access Benefit-Risk Analysis Dose the drug do more good than harm in a defined group of patients? What are the health and cost consequences associated with this drug relative to others in a defined group of patients? Cost-Effectiveness Analysis How does the drug perform relative to others in realworld patients? Am I willing and able to pay for this drug out-ofpocket? Comparativeeffectiveness research Willingnessto-Pay Analysis Adpated from Eichler, Nature 2010

34 Modernized approaches In the following aspects of clinical development Better evaluation biomarker as a good representative of clinical endpoint Streaming Trials seamless design (e.g., phase Ib/IIa), measurement (patient-reported outcome) Bioinformatics data mining from big data At-risk population special subjects (pediatrics, aged, hepatic impaired, renal impaired, and so on)

35 TPP and CDP 특히국내사경우 Clinical Development Plan

36 경청감사합니다. 문의사항은아래주소로연락바랍니다.

PowerPoint Template

PowerPoint Template Regulatory Inspection and Quality Improvement of Korean IRBs Young-Mo KOO, AMC, Seoul, KOREA Jeong Mi KIM, KFDA, Seoul, KOREA Trends in the globalization of clinical trials Nature Review 7:13-14, 2008