CLINIQUES UNIVERSITAIRES SAINT-LUC, Brussels (BE) Ursula Morjaria Director Clinical Trial Center 13 October 2016 Clinical Trials Excellence Forum
OPERATIONAL EXCELLENCE FROM THE PERSPECTIVE OF AN ACADEMIC UNIVERSITY HOSPITAL CLINICAL TRIALS IN BELGIUM CLINIQUES UNIVERSITAIRES SAINT-LUC: FACTS & FIGURES CREATION OF THE CLINICAL TRIAL CENTER (CTC) CTC VISION & MISSION FOUS AREA Regulatory affairs Quality assurance Support to academic research Reporting Financial Ressources optimization 2
CLINICAL TRIALS IN BELGIUM Belgium historically holds a strong leadership position in clinical trials N 1 European country in terms of per capita participation in trials COMPETITIVE ADVANTAGES Short approval timelines and good predictability of these timelines Highly qualified clinical researchers & research centers Highly qualified competent authorities & ethics committees Biopharmaceutical ecosystem : i.e. a positive environment in which biopharmaceutical companies can work closely together with universities and other companies WORLD LEADER IN CLINICAL TRIALS Every year >170.000 Belgian patients participate in phase 2 and 3 trials Over the last 6 years >228.000 Belgian cancer patients participated to a clinical trial In 2014 >1.500 clinical trials ran in Belgium vs 1703 to date Top 4 domains: 21.0 % cancer; 13.0 % CVD; 8.3 % CNS; 7.6 % respiratory disease Source: Pharma.be, PWC report 2012 3
CLINICAL TRIALS IN BELGIUM NUMBER OF NEW CLINICAL TRIAL APPLICATION IN BELGIUM FROM 2011 TO 2015 (Source FAMHP) 4
CLINIQUES UNIVERSITAIRES SAINT-LUC, Brussels (BE) 5.796 employees * 60% full time 77% permanent position * 30/09/2014 One of the top private employers in Brussels 5
CLINIQUES UNIVERSITAIRES SAINT-LUC, Brussels (BE) Inpatient days (classical) 229.000 Inpatient days (medium term hospital care) 20.000 Surgeries 20.600 One-day clinic and dialysis 42.900 Consultations 540.000 Emergency admissions 72.500 Deliveries 1.840 Medium hospital-stay 6 days 2015 Figures 6
CLINICAL TRIAL CENTER 2014 Towards the creation of a Clinical Trial Center Legal and regulatory frameworks Europeandirective 2001/20/EC definesthe roles and responsibilities of sponsors and investigators, particularly in academic trials, The CTC ensuresthe Quality Management System is alignedwiththe 7 May 2004 lawas well applicable directives and standards governing cinical research. Coming in 2017-2018, the new European regulation(eu 536/2014), replacing the above, will set single entry portal for clinicaltrials submissions. The CTC prepares the institution to keep up competitiveness and adaptability. 7
CLINICAL TRIAL CENTER 2014 Towards the creation of a Clinical Trial Center Industry demand- Improve the positioning of Belgian sites & Operational excellence Creation of hospital and clinical research networks Creation of patients database Standardization/centralization of procedures, processes and ressources (dual model) Common tools Governance model: under the leadership of the Medical Director Head of medical departments Head of research institutes of the UCL University Support functions: finance, RA/QA 8
CTC MISSION & VISION MISSION To professionnalize clinicalresearch and coverall dimensions related to commercial and academic research, from an economic and scientific perspective VISION Center of excellence Centralized body Differentiated and attracting talent Encouraging best in class healthcare STRATEGY To developa clinical researchbasedon qualityand innovation; a quantitatively significant researchcontributingto the development of the institution in line with the patient care and the university program FOCUS AREA Regulatory/ quality Financial Support to Reporting HR academic research 9
ORGANIZATIONAL CHART CLINICAL TRIAL CENTER Director Clinical Trial Center Medical Director Manager RA/QA Reporting specialist Manager Contracts& Budget Manager Study Coordinators/flex. staffing AcademicTrials Coordinator Single Point of Entry Contracts Specialists Study Coordinators Dual structure: study coordinators 10
FOCUS AREA REGULATORY AFFAIRS Memberof the CHAB workinggroup on standardizationof Master Agreements for academic and industry sponsored trials Academic trials: support to the Investigators for the submissions to Competent Authorities Collaboration with the Ministry of Health and Famhp -Workinggroups on the impact of the new CTR - Measures to maintain Belgium competitiveness in attracting clinical trials QUALITY AAHRPP accreditation obtained in September 2015 Buildup and maintenance of the QMS Development of internal tools and systems: QMS, CTMS Training on GCP, applicable laws& regulations, SOP s: MANDATORY Audit program escalation plan 11
ACCREDITATION OF CLINICAL RESEARCH ACTIVITIES AAHRPP Accreditation: (Association for the Accreditation of Human Research Protection Program): September 2015: First hospital fully accredited in Europe Quality label Recognition that the hospital follows the standards of ethics and quality in the management of its clinical research activities Covers process and procedures, organizational management and patient protection Position the institution at the top in the eyes of healthcare professionals, regulatory authorities and the pharmaindustry from a Belgian and International stand point This is a project initiated in 2012 and sponsored by INNOVIRIS, the Brussels Institute for research and innovation. 12
AAHRPP Earn the respect and meet the expectations of their peers. Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process. Play a leadership role in collaborative efforts. AAHRPP accreditation instills trust among research partners and, therefore, is becoming a requirement for collaboration. AAHRPP-accredited organizations often insist that accreditation status be a determining factor in decisions on external IRB review. Gain a competitive edge with sponsors and other funders, who recognize that AAHRPPaccredited organizations have more efficient operations, provide more comprehensive protections, and produce high-quality data. Virtually all sponsors require independent IRBs to be AAHRPP accredited. Some sponsors also consider accreditation status when choosing investigative sites. Reduce the risk of non-compliance. AAHRPP accreditation signifies that an organization has built the necessary infrastructure for a quality human research protection program (HRPP). AAHRPP-accredited organizations tend to have more streamlined, effective policies and procedures. These organizations also typically keep better records and are more likely to avoid costly shutdowns and problematic inspections. Benefit from a common commitment to continuous quality improvement. AAHRPPaccredited organizations share innovative practices and collect data to help establish benchmarks and assess quality improvement. AAHRPP compiles and distributes these data to aid organizations, sponsors, government agencies, and participants in identifying and promoting highquality practices. Source: AAHRPP website 13
AUDIT PLAN 2016 ETHICS COMMITTEE Commercial and non-commercial Annual reports CAPA management Pharmacogovilance INSTITUTION Commercial and non-commercial Annual reports CAPA management Pharmacogovilance SOP s Directives Regulations National laws GCP ISO 14155 CLINICAL TRIAL CENTER: Contracts& budgets 14
TRAININGS GCP TRAINING: valid 3 years Face to face training organized within the institution Online version available on Intranet FACE TO FACE TRAININGS ORGANIZED WITHIN THE MEDICAL DEPARTMENTS - INVESTIGATORS - STUDY COORDINATORS - ETHICS COMMITTEE FACE TO FACE TRAINING ON INTERNAL TOOLS AND SYSTEMS REGULATORY TRAININGS MANDATORY 15
INTRANET TOOLS AND SYSTEMS ENNOV Software for the quality management in clinical research(allows the filing, the document management (expiration, update, signature cycle, archiving with a user interface) All internal procedures and documents related to clinical research CLAIRE Institution software dedicated to clinical research: ensure traceability of clinical studiesand patients (link with Med Ex), accounting, ethics committee, pharmacy, study coordinators, investigators Access granted to people involved in clinical research within the institution TRAININGS (GCP, IATA ONLINE) WEBSITE: All procedures and documents for the submission to the Ethics Committee 16
FOCUS AREA SUPPORT TO ACADEMIC RESEARCH: inform/promote/facilitate Academic trial coordinator: Identification and quantification of support needed by the investigator: data management, statistics, medical writing, study coordination, pharmacovigilance Support to investigatorsfor submissionsto Ethics Committee and Competent Authorities Coaching of central study coordinators dedicated to academic research SINGLE POINT OF ENTRY Registration into internal clinical trial management system (CTMS) Validation of dossier before submission to Ethics Committee Registration into ClinicalTrials.gov 17
GUICHET UNIQUE/SINGLE POINT OF ENTRY Support to investigators for Ethics Committee submissions Reduction of administrative tasks FasterEC review Reception of all commercial and non-commercial trials Assessment of regulatory requirements per study type Advise Feasibility Help desk Registration into Clinicaltrials.gov 18
INFORMATION & REPORTING FOCUS AREA Increasedvisibilityof the CTC on CUSL website for a better reachto patients, industry, academic sponsors Development of Key Performance (Academic Research) Indicators Initiative on process improvements: e-signatures, electronic transfer of images Annual activity report FINANCIAL Preparation of contracts and budgets for all clinical trials Promote the use of Master Agreements Initiative for reduction of lead time for Clinical Trial Agreements 19
FOCUS AREA RESOURCES OPTIMIZATION Central hiring process for all study coordinators Flexible demand model Implementation of a flexible pool of study coordinators for resources optimization Onboarding before placemement into medical departments Mappingof existingcapacity, rolesand responsibilities, profiles, Sessions of best practice sharing 20
KCE TRIALS: GAP ASSESSMENT - Assessment of sponsor capacity at universities and hospitals -Publicly funded program of pragmatic practice-oriented trials, to build a network of clinical trial units which can take up the function of a clinical trial sponsor. The initial focus will be university hospitals since they are the most likely candidate sponsors for the clinical trials financed by the KCE under this program. -Scope and focus: ICH-GCP and sponsor processes necessary to be able to initiate, execute, manage and oversee multicentre pragmatic comparative effectiveness trials, including: - Overall Management System - Selection of sponsor staff involved in the management and oversight of study conduct and relevant training - Document Management processes - Quality processes, including audits, non-conformance/capa management, process improvement, quality management reviews - Study design, performance, analysis and reporting including, protocol development and medical oversight, site selection and oversight process 21
KCE TRIALS: GAP ASSESSMENT 22
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