Coordination Center For Clinical Studies KKS Charité

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Coordination Center for ClinicalStudiesKKS CharitéUNIVERSITY MEDICINE B E R L I N1

Quality management in clinicalresearchHow could a network facilitate qualitymanagement of an academic sponsor?Rita Pilgerrita.pilger@charite.deUNIVERSITY MEDICINE B E R L I N2

KKS* / ZKS** - History1990ies and ICH GCP: Increasing complexity for clinical trials and decreasing numbers ofnon-commercial clinical trails Insufficient quality of clinical trials results (data and timelines) Insufficient knowledge of methods for clinical trials in the academiccommunity Within the framework of a funding programme of the German FederalMinistry of Education and Research (Bundesministerium für Bildungund Forschung BMBF) in 1999/2000 and 2002– 12 Coordinating Centres for Clinical Trials at the medicalfaculties of university hospitals.– Implement a nationwide quality campaign at academic sites– Establish the same standards all over Germany. KKS Network, allowing a harmonised approach and the effective use*KKS: Koordiationszentrum für Klinische Studien Coordination Center for clinical Studiesof synergies** ZKS: Zentrum für Klinische Studien Center for clinical StudiesUNIVERSITY MEDICINE B E R L I N3

KKS NetworkUNIVERSITY MEDICINE B E R L I N 17 Members: Centres for Clinical Trials inuniversity hospitals throughout Germany(approximately 600 staff members) Independent institutions, connected to theiruniversities Support for all types of clinical trials (withmedicinal products, medical devices, orepidemiological studies) in phases I to IV onall medical indications All relevant services, from study design topreparing the final trial report Partner of ECRIN in Germany Cooperation among the members in severalprojects (e.g. monitoring)4

Coordination Center for Clinical StudiesKKS Charitéfunded by the Federal Ministry of Education andResearch from 2002 to 2008part of the Charité Center for Therapy and ResearchServices: project mangement, regulatory affairs, studyplanning, biostatistic, data management, QA/QC,monitoring, study nurses, (pharmco)vigilance, reportingUNIVERSITY MEDICINE B E R L I N5

Legally required activities depending on thestudy typeStudy typeExampleRegulatoryAffairsBiometrypCRF/ eCRFDatamanagementMonitoringVigilanceStudy NurseCoordinationLegally requiredInterventional- Drugs1 (Phase I – IV)- Medical devices- BiomarkerAMG/ MPGIRB /CA Noninterventional- Epidemiological2- PMS3, PASS4- Therapy studies5- Observational Studies- Registry- Diagnosticsnon-AMG/non-MPGIRB6 7 7 Regulatoryframework1also ATMPs, biotechnologically produced drugs, tissue preparations, etc.2Case-Control-Studies, Cohort Studies3Post-Marketing Studies4Post Authorization Safety Studies5non interventional67Scope of performance depends i.a.:-study type/ duration-number of sites/ patientsif necessary notification only-data volumeif compliant with ICH-GCP, but not legally required for non-interventional studies- UNIVERSITY MEDICINE B E R L I N

Quality in a clinical trialQuality in clinical research may be defined as. Reliability and credibility of information providingan answer to a scientific question Compliance of the trial process with definedrequirements (ICH-GCP, national regulations)UNIVERSITY MEDICINE B E R L I N7

Project management: Quality PlanningStudy C/CAOutlineStaffInitiation ofstudyLogisticProtocolCo-SponsorStartSelection ofpartnersStudyconductStudyAnalysisData management DatamanagementSurviellence (PhV)StatisticalLogisticevaluationStudy reportreport/publipublicationcationMedical writingScientific BoardContractingQA / OPsStudy sFacilitiesSOPsUNIVERSITY MEDICINE B E R L I N8

Aim: Quality improvement Cooperation between the KKS but which standards have to be applied? Implementation of concerted SOPs within a federal structure All members of the KKS-Network committed themselves to implementthe concerted SOPs unchanged into each QM system. Working Group QM: Representatives of each KKS developed acollection of harmonized SOPs. Harmonization process of the SOPs improves the cooperationwithin the CTC network considerably especially for mulitcenter trialsUNIVERSITY MEDICINE B E R L I N9

SOP SystemModular structureAll SOPs developed by the CTC network are accessible on the TMFhomepage for all interested parties free of chargeUNIVERSITY MEDICINE B E R L I N10

Problems and gaps Variabel QM systems and infrastructure Increasing topics and issues Issues concerning sponsor overallresponsibilities (delegation gap) Processes during study conduct at studysites Maintainance of SOP systemUNIVERSITY MEDICINE B E R L I N11

Various QM systems and infrastructure introducingdesignated paragraphs intended for localspecification Processes during study conduct at study sites SOPtemplates dealing with all operational processesduring clinical trials at study sites/SMOs.UNIVERSITY MEDICINE B E R L I N12

Increasing topics and issuesGood SOPs are prerequesites but notsufficient Expert panels with the mission: Development of standardsSOPsSupportDiscussion on impact of regulations andlawsUNIVERSITY MEDICINE B E R L I N13

Expert panels in the KKS network Training programmsContens of training programms, curricula Data managementData management processes BiostatisticProcesses for biostatistics, methods Quality managementSOPs, quality standards Site managementStudy conduct, organisation of sites ITIT infrastructure VigilanceSAE Mangement, (pharmaco)vigilance infrastructure, processes Project managementStudy preparing, study documents, CTA, archiving MonitoringStandards, ADAMON,UNIVERSITY MEDICINE B E R L I N14

Working Group Sponsor responsibilities– Issues concerning sponsor overall responsibilities(delegation gap) Working group sponsorresponsibilities– ICH –GCP: 5.7 Allocation of ResponsibilitiesPrior to initiating a trial, the sponsor should define,establish, and allocate all trial-related duties andfunctions. Organisation of an academic sponsor SUPERVISION OF DELGATED TASKSUNIVERSITY MEDICINE B E R L I N15

Sharing experienceReliability and credibility of informationproviding an answer to a scientific question Documentation and data quality Data generation standards Data center certification program (ECRIN) Software supervision of siteperformance; central monitoringUNIVERSITY MEDICINE B E R L I N16

Problems More or less acceptance of KKS by theiruniversity hospitals Economic pressure Competition among KKS (funding of projects) Various infrastructure (comparability ofsystems) Maintainance of developed SOPsUNIVERSITY MEDICINE B E R L I N17

KKS Network and his impact on quality Development of standards Impact through lobbying: discussion on new legalregulation (e.g. EU regulation) and their feasibilityin non commercial clinical trials Improvement of the understanding of potentialrisks and problems in clinical trials Think tank expertise and quality improvementUNIVERSITY MEDICINE B E R L I N18

Thank you for your attentionetMerci beaucouppour l‘invitationContact:Rita PilgerKKS Charitéwww.kks-charite.dePhone: 49 30 450 553 872eMail: rita.pilger@charite.deUNIVERSITY MEDICINE B E R L I N19

UNIVERSITY MEDICINE B E R L I N KKS* / ZKS** - History 1990ies and ICH GCP: Increasing complexity for clinical trials and decreasing numbers of non-commercial clinical trails Insufficient quality of clinical trials results (data and timelines) Insufficient knowledge of methods for clinical trials in the academic community With

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