Clinical Trials Management - Fit For Health 2.0
Clinical trials managementin Horizon 2020 projects22.01.2015 Brussels, BelgiumClaudia Schacht Eurice GmbH
22.01.2015Clinical trials managementBrussels, BelgiumWhat is a ‘clinical trial’ in H2020?‘Template for essential information to be provided for proposals includingclinical trials / studies / investigations’ DEFINITION:A ‘clinical study’ is defined for the purpose [of this template] is any clinicalresearch involving a substantial amount of work related to the observationof, data collection from, or diagnostic or therapeutic intervention onmultiple or individual patients. It includes but is not limited to clinical trialsin the sense of the EU Clinical Trials Directive (2001/20/EC). Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumCharacteristics of these clinical studies work with patients collect data from patients special part of your project with certain characteristics that are different from restof your project / ‚classical‘ collaborative project Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumChallenges of these clinical studies .around patient recruitment and management .around data collection and management Integration into rest of the project Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumWhy clinical trials?The implementation of clinical trials in a collaborative, transnational approach has aclear European added value: easier to reach sufficient patient numbers (especially in the case of rare diseasesand stratified treatment groups) faster recruitment rates consolidated expertiseIn addition, clinical trials are the ultimate validation step for any innovation in clinicalHealth Research, bringing innovations to markets and patients – one of the mainobjectives of Horizon 2020. Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumTypical challengesProject extensions Communication by the EC on “Restrictions on extensions to the duration of grantagreements, and respect of reporting deadlines“ (June 2014)[ ] recent experience has shown that nearly 50% of grants are not completed in thetimescale set out in the Grant Agreement, but are extended through an amendment. Thislevel of amendments shows that it is no longerthe exceptional procedure that it was intended tobe, but has become a common practice in the 7thFramework Programme. For this reason, theCommission services will, in future, more closelyexamine each request for an extension to theduration of the project to ensure that they are onlygiven where there is a clear added value for theproject, or where external events (not reasonablyforeseeable at the point of signing the grant)mean that it is impossible to complete the work inthe agreed timeframe.
22.01.2015Clinical trials managementBrussels, BelgiumTypical challengesEven among ‘regular’ FP7 projects: 50% of grants were not completed in time & had to be extended through an amendmentClinical trials are known to be particularly complex literature: up to 85% of clinical trials in general are not completed in time most common reasons for delays: site initiation and patient recruitment often leading to cost increase Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumTypical challengesH2020 project clinical trial ‘double challenge’BUT maximum EC contribution per project is fixedtimely completion of projects / quick translation of research results into application is adeclared goal under Horizon 2020To help overcome these challenges, the European Commission provides clear guidance on howto optimally plan and describe your study in the proposal phase, and has adapted theirfinancial rules in appreciation of the special requirements of clinical trials. Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues1. Before start of study Protocol development Ethical approval2. During study implementation: Patient recruitment Patient availability / recruitment delaysFinancing issuesData collection CRFsData entry/integration, QC3. Conclusions & useful links and reference documents Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues1. Before start of study Protocol development Ethical approval Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: site initiationProtocol development- Harmonized study protocol across sites needed to start the work- Only outline of protocol required in proposalEthical approval- Not required for proposal submission, but indispensable for uptake of activities- H2020: very short time to grant!If not in place already: Designate one person in charge who will drive protocol developmentand ethics applications instantly. (Note that costs for related activities can only be reimbursed ifthey occur during project duration.)Final protocol & ethics approval mandatory deliverables Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues1. Before start of study Protocol development Ethical approval2. During study implementation: Patient recruitment Patient availability / recruitment delaysFinancing issuesData collection CRFsData entry/integration, QC Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: patient recruitmentPatient availability / recruitment delays- Estimates based on thorough feasibility analyses- Common challenges: higher than expected drop-outs, new competing studies, changes inlegislation, changes related to personnel conducting the work.- Upcoming challenges MUST be reported quickly and fully Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: patient recruitmentPatient availability / recruitment delays- Estimates based on thorough feasibility analyses- Common challenges: higher than expected drop-outs, new competing studies, changes inlegislation, changes related to personnel conducting the work.- Upcoming challenges MUST be reported quickly and fully-Management- must establish a trustful and close relationship with each site- must know and optimize workflows, and reduce admin challenges to a minimum- should be ready and able to react promptly- should ensure a close monitoring of recruitment numbers at all sites- must have strategies in place to compensate for lower than expected patient numbers,reaching the original targets in the original timeframe with the fixed budget Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: patient recruitmentFinancing issues- sites may not be aware of or experienced with the principle ofreimbursement/instalments/negative cashflow- high workload, large number of individuals involved per site, continuity must be ensured- shifting of activities related to patient recruitment is common- if leading to a decrease in patient numbers: prepayment exceeding max funding? Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: patient recruitmentFinancing issues- sites may not be aware of or experienced with the principle ofreimbursement/instalments/negative cashflow- high workload, large number of individuals involved per site, continuity must be ensured- shifting of activities related to patient recruitment is common- if leading to a decrease in patient numbers: prepayment exceeding max funding? Reduce riskby opting for instalment option in CA- unit costs or subcontract option were created to increase flexibility- know the system and typical challenges to minimize risk & optimize your project- provide close support to recruiting centers Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: data collectionCRFs- paper and/or electronic version (PC vs mobile devices)- established vs new system- amendments during the project difficult/impossibleData entry/integration, QC- key to secure generated data and ensure their usability- only data that are in the database can be processed bottleneck- option: dedicated data entry clerk Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues: data collectionCRFs- paper and/or electronic version (PC vs mobile devices)- established vs new system- amendments during the project difficult/impossible- ensure sufficient training of personnel who will be filling out the CRFsData entry/integration, QC- key to secure generated data and ensure their usability- only data that are in the database can be processed bottleneck- option: dedicated data entry clerk- ensure sufficient training of personnel who will be entering the data- implement continuous monitoring/control mechanisms- keep an eye on the time needed for completion of following tasks to determine data entrydeadlines Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumManagement issues3.Conclusions & useful links and reference documents Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumConcluding remarksTimely completing of planned work is particularly challenging in clinical studiesTips for Minimizing Delays1. Start work immediately to ensure timely site initiation2. Revisit site assessment regularly – Review/obtain key operational criteria and information onadministrative capacity to optimize calculations of expected patient distribution (continuousprocess)3. Adapt your project management approach - Structures and activities need to acknowledgethe inherent variability of the process and allow for quick identification of difficulties, andprompt changes/adaptations during implementation4. Build relationships – the responsible project management team must create an authentic,responsive relationship with each of the sites. Site visits early on often pay off in the course ofthe project. Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumInfo and supportSources of advice and support: National Contact Points FAQs concerning the H2020 societal challenge “Health, demographic change and /1620101-2014 2015 -2014 07 31 sc1 h2020 faq en.pdf EU IPR helpdesk: www.iprhelpdesk.eu FFH 2.0 CT factsheet FFH 2.0 support Fit for Health 2.0, 2015
22.01.2015Clinical trials managementBrussels, BelgiumThank you!Claudia Schacht Eurice GmbHc.schacht@eurice.eu www.eurice.eu
22.01.2015 Brussels, Belgium Clinical trials management Typical challenges Even among ‘regular’ FP7 projects: 50% of grants were not completed in time & had to be extended through an amendment Clinical trials are known to be particularly complex literature: up to 85% of clinical trials in general are not completed in time most common reasons for delays: site
Bruksanvisning för bilstereo . Bruksanvisning for bilstereo . Instrukcja obsługi samochodowego odtwarzacza stereo . Operating Instructions for Car Stereo . 610-104 . SV . Bruksanvisning i original
IT9358 Good Clinical Practices (GCP) 1.8 IT9387 Clinical Trials Monitoring 1.8 IT9388 Clinical Trials Design 1.8 IT9359 Clinical Data Management 1.8 IT9386 Biostatistics 1.8 IT9531 Introduction to Regulatory Affairs (US) 1.2 IT9539 Safety Monitoring 1.2 IT9351 Clinical Project Management I 1.8 IT9354 Clinical Project Management II 1.8
Ebbinghaus’s Forgetting Curve For example, if Ebbinghaus took 12 trials to learn a list and 9 trials to relearn it several days later, his savings score for that elapsed time would be 25 percent (12 trials – 9 trials 3 trials; 3 trials 12 trials 0.25, or 25 percent). Using savings as his measure,
50 practice-changing clinical trials whose results were announced between 2014 and December 2020. The trials are presented under the CTEP-supported clinical trials program in which they were conducted. Studies Conducted by the National Clinical Trials Network (NCTN) o RxPonder (SWOG S1007)—The Rx for Positive Node, Endocrine Responsive Breast
Clinical Trials and CAM Introduction Clinical trials are an important part of medical research. They help scientists find better ways to prevent, detect, and treat diseases and medical conditions. This fact sheet provides an introduction to clinical trials in general and also to trials involving compl
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