Conducting Academic Trials Under EU Law The EBMT Experience. Zoë Doran Director, Clinical Trials Operations EBMT
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1 Conducting Academic Trials Under EU Law The EBMT Experience Zoë Doran Director, Clinical Trials Operations EBMT
2 Sponsorship Major Challenges The Approval Process Monitoring/Quality Assurance Support Infrastructure
3 Sponsorship The Problem? Requirement for Overall Sponsor
4 Sponsorship Potential Solutions 1. Funded Studies Sponsor academic group Sponsor national body Sponsor university Sponsor lead institution
5 Non funded studies: a creative approach Lyon, March 2007
6 Sponsorship Potential Solution 1. Non - Funded Studies A sponsor may delegate any or all of his trial-related related functions to an individual, a company, an institution or an organisation. However, in such cases, the sponsor shall remain responsible for ensuring compliance
7 Delegation by Contract Delegates ALL sponsorship obligations to each centre Sign-off EBMT highest level MUST be signed by institutional Representative (written( documentation of authority) ) as well as PI responsibilities institutional and intra- departmental
8 The Contract Insurance Translations Submissions Data Management Pharmacovigilance Monitoring
9 But remember! EBMT figurehead.but legally responsible Participating Institutions in reality self sponsored.but legally not responsible
10 The Approval Process The Problem? What? When? To whom? How many? Translate? The paperwork maze
11 National Approval Approval at an Institutional Level
12 The Paperwork Maze Local requirements Local government Institution local ethics, R&D, pharmacy, agreements Language barriers information/required submission documents
13 Potential Strategies Process in parallel Personal communication Ethics / CA Institutional Governance No extra costs to institution Pharmacy Legal additional liability protocol focussed
14 Potential Strategies Provide documentation for the most conservative If in doubt submit let the authorities make the decision (e.g. IMP or not) Grey Area get it in writing Ensure that academic status clear Compile central files of requirements based on available info, updated by experience
15 Potential Strategies Bank information CA/EC addresses CVs Lab norms Centre information
16 Monitoring/Quality Assurance Monitoring Obligations Initiation, During, Close What and by whom not specified Tailor to resources checking of data quality (QA) safety
17 Potential Strategies Use of teleconferences supported by slides to initiate Monitoring CROs, Inter/intra departmental, remote Focus on safety and protocol compliance Keep it simple and standardise CRFs Patient files
18 Potential Strategies Quality Assurance/End Point Review Investigator review endpoints Institution Overall Central review Lab data Digital scans
19 Current Support Infrastructure London Director, CTO PCT Op Mgr Coordinators 2FTE Supervisor 1 FTE Database manager 0.5 FTE Leiden Coordinators 1.5FTE Data manager 1FTE IT support 8hrs/week Leipzig Monitor 1FTE
20 Current Infrastructure Relatively small team Language issues Reliance on Country leads Institutional resources End Result Deceased control/takes longer
21 The Ideal The Future Central support administration to submit and support centres Vital in the EU era Needs Investment
22 Stop Gap for Today Consider Chose country leads with care Ethical committee Local resources Give maximum support centrally EudraCT/CTA applications Templates Minimal number of countries/institutions
23 Conclusions Academic Research is no longer a weekend activity Requires greater commitment from participating centres Be creative, explore your options/resources Adapt The more you do the better you get Not easy but nor is it impossible!
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