REACTA Forum 2014 참가후기 2014.11.21 세브란스병원 연구원 최청암 Outline • REACTA Forum 2014 • Collaboration in industry (NonTransCelerate) • 제약회사 (Daiichi Sankyo) • 임상시험 센터 (삼성서울병원 CTC) • CRO (INC Research Korea) REACTA (REgional Asian Clinical Trial Association) • CTC (주로 Asia 지역)의 모임 – Korea, Japan, Taiwan, HK, US, and Malaysia • REACTA Forum 2014 부산 동아대에서 개최 2014.11.6-7 • Guiding purpose – 상호 협력 – 교육 – Regulatory harmonization 1. Yoon-Duk Han, TransCelerate OPTIMIZING THE CLINICAL TRIAL PROCESS THROUGH COLLABORATION TransCelerate • A non-profit organization focused on advancing innovation in – R&D – Improving patient safety – Delivering more high quality medicines • Discusses issues facing the industry and solution for addressing common challenges • Support of the original 10 founding biopharmaceutical company members Source: TransCelerate, 2014 ARCS Scientific Congress Source: TransCelerate, 2014 ARCS Scientific Congress Source: TransCelerate, 2014 ARCS Scientific Congress Source: TransCelerate, 2014 ARCS Scientific Congress Source: TransCelerate, 2014 ARCS Scientific Congress Source: TransCelerate, 2014 ARCS Scientific Congress 2. Koichi Miyazaki, Daichi Sankyo Co., Ltd EFFICIENT MULTINATIONAL CLINICAL TRIALS FOR PATIENTS IN ASIA Increasing trend of clinical trial activity in Asia Source: REACTA Forum 2014 The number of studies per 100 M people Sufficient capacity available in Asia for increased demend Source: REACTA Forum 2014 Protocol deviation (deviation/patient) Source: REACTA Forum 2014 Proposed investigator grant for completed case Clinical trial in Asia is cost effective Source: REACTA Forum 2014 Enrollment speed (enrollment/sites) Source: REACTA Forum 2014 Clinical trial by phase Source: REACTA Forum 2014 Contribution from each region • … small region should contribute at least 21.3% of the patients… • …guarantee reasonable power of … at least 20% Asian authorities may request more data from Asia Source: REACTA Forum 2014 Development strategy (past) Source: REACTA Forum 2014 Development strategy Source: REACTA Forum 2014 Clinical study in Asia • Quality, cost and speed of Asia study are competitive • Asia should be involved from early stage trial to consider ethnic differences • Ideally, each region should contribute at lease 20% of the patients to ensure the consistency across regions Source: REACTA Forum 2014 3. YoungSuk Park, SAMSUNG Medical Center CTC SAMSUNG MEDICAL CENTER CLINICAL TRIAL CENTER SMC CTC Introduction • 1995 1상 임상시험 실시기 • 2008 보건복지부 지역임상 관 지정 시험센터 및 3개부문 지정 • 2001 美보건아시아 최초로 • 2010 미래의학센터 설립 실시기관 및 IRB등록 • 2006 AAHRPP 전면인증 • 2007 Pfizer CORE Research Site 지정 • 2012 BMS Oncology Center of Excellence Sanofi Premier Site 지정 • 2013 보건복지부 연구중심 병원 지정 Source: 삼성서울병원 임상시험센터 website SMC CTC Introduction 1400 1200 1000 800 600 303 SIT 238 400 200 310 261 299 585 895 729 781 809 2010 2011 2012 2013 25 75 113 56 20 76 112 56 30 71 119 50 0 2009 Phase Phase Phase Phase Source: REACTA Forum 2014 1 2 3 4 IIT Phase 1 Unit Team at CTC □ Technology for early phase trials □ Member Researcher Number Pharmacologist 6 Pharmacist 2 Operation 1 CRC Oncology 6 • – – – – 2 PK 6 Source: REACTA Forum 2014 Single ascending dose Multiple ascending dose Drug-Drug Interaction BA/BE • Proof of Concept Study with New Biomarkers • Through QT/QTc Study • Multi Omics (Genomics/Proteomics/Metabolomics) • PK/PD M&S • New Statistical Tools for Innovative Design Healthy Volunteer 6 Nurse Phase 1 Study Personalized Tx Clinical at ICMI Source: REACTA Forum 2014 SMC & Industry Collaboration Cases Source: REACTA Forum 2014 Translational CRO Functions Source: REACTA Forum 2014 3. Hailey Chae, INC Research Korea SITE SELECTION Site Selection Process • • • • Potential Investigators Evaluate Criteria Feasibility Study Pre-study Visit Source: REACTA Forum 2014 Identifying Potential Investigators • • • • • • Literature Review Medical Society Directories Investigator Database Reference from Investigator Professional Colleagues Regulatory Lists Source: REACTA Forum 2014 Site Evaluation • Experience with similar trials • Interest Level (Prompt response for feasibility & any queries) • Patient pool • Competing trials • Resources (study coordinator/Sub-I/Rater) • EC (SOP/approval timeline/contract process) Source: REACTA Forum 2014 Site Evaluation • Staff – Study coordinator/Sub-I/Rater – General interest & attitude – Training • Facility – Storage for study supplies – Archiving practices: study documents – Device calibration: Freezer/Blood pressure Source: REACTA Forum 2014 Certification Competition Compliance Contract Cost Expertise Experience Equipment Ethics committee Local lab Logistics Language Source: REACTA Forum 2014 Time Training Criteria Subject Staff Space & storage Selection of site is both the Art and Science of Investigating Investigator Source: REACTA Forum 2014 Factors influencing clinical trial site selection in Europe • Applications to run clinical trials in Europe fell 25% between 2007 and 2011 • 19 factors explored: across investigator-driven, hospital-driven and environment-driven criteria, and costs. It also surveyed perceptions of the European trial environment • Investigator-dependent, environment-dependent and hospitaldependent factors were rated highly important, costs being less important • Within environment-driven criteria, pool of eligible patients, speed of approvals and presence of disease-management networks were significantly more important than costs or government financial incentives Source: REACTA Forum 2014 Investigator-driven criteria in the selection of phase II-III trial sites Criteria Mean Investigator recruitment/retention track record 27.3 Investigator experience in previous trials 22.7 Investigator interest 22.4 Investigator concurrent workload 17.2 Investigator publication track record 10.4 Source: REACTA Forum 2014 Environment-driven criteria in the selection of phase II-III trial sites Criteria Mean Size of marketing/eligible patients in a region 23.8 Speed of MoH/Ethics committees approval 23.4 Disease management system/networks 18.9 Cost of running trial 15.2 Presence of country on ‘core country list’ 11.8 Source: REACTA Forum 2014 Hospital-driven criteria in the selection of phase II-III trial sites Criteria Mean Site personnel experience and training 22.0 Previous experience with site 20.0 Facilities/equipment required by trial 19.7 Hospital approval/contracting system 17.4 Site personnel language proficiency 10.8 Source: REACTA Forum 2014 Source: REACTA Forum 2014 Institutional Considerations to procure more projects • Expand experience and qualified investigator pool by active involvement of sub-investigator group • Establish and maintain qualified and welltrained study coordinator resource via clinical trial center • Update regular trial experience and patient pool (Web-based/Newsletter) • Streamline and control feasibility process • Obtain regular feedback from industry Source: REACTA Forum 2014 끝! 감사합니다.