The importance of international. Collaborations in rare diseases
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- Domenic Robertson
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1 The importance of international collaborations in rare diseases the EURAMOS model Matthew Sydes Senior Medical Statistician MRC Clinical Trials Unit, London
2 Overview Aim of presentation: 1 Introduce rationale for collaborations 2 Clarify central trial structures in EURAMOS model 3 Help understand how we fit together
3 Research & RCTs Wish to improve outcomes for all patients Common diseases Rare diseases Address right questions at right time RCTs provide systematic assessment Randomisation as basis for fair comparison
4 Osteosarcoma Rare disease eg 150 cases/year in UK Opportunity to improve outcomes based on risk stratification Two good questions 1. Good responders Maintenance therapy? 2. Poor responders Additional drugs?
5 Design Time Biopsy-proven diagnosis of resectable osteosarcoma 1400 patients REGISTER MAP (induction) 693 patients 567 patients Surgery Poor Histological response assessment Good RANDOMISE RANDOMISE MAP MAPIE MAP MAP-ifn
6 Typical rare disease Reliable answers require many patients Register 1400 patients Randomise 567 Good responders Randomise 693 Poor responders Could any single country do this? Clearly not
7 Typical rare disease Reliable answers and Reasonable time frame because Hopefully, further good questions will arise True in osteosarcoma questions appearing
8 Intergroups Collaborations to work together eg EOI European Osteosarcoma Intergroup formed 1982 mostly northern Europe but some wider trial participation (Chile, Argentina, S Arabia) leads to trials and improved recruitment totals
9 Intergroups 3 rd EOI trial (MRC BO06 / EORTC 80931) * second largest OS trial 504 pts over 9yrs from 11 countries 1 patient per week Could EOI-sized group answer our questions? Not quickly, if at all Sometimes Intergroups needs to go wider * Lewis, Nooij, Whelan et al. Improvement in Histologic Response But Not Survival in Osteosarcoma Patients Treated With Intensified Chemotherapy: A Randomized Phase III Trial of the European Osteosarcoma Intergroup.J.Natl.CancerInst. 99 (2): , 2007.
10 Large international Intergroups EURAMOS Intergroup EOI western Europe COSS central Europe SSG Scandinavia COG USA + Canada Aim for 400 patients/year 7 patients per week 350 patients per year 1400 patients over 4 years
11 Large international Intergroups Sounds easy Maybe, at sites, just like any other research Is it easy? No: many challenges Can Intergroups work? Yes With care, attention, patience, awareness EURAMOS as an example
12 What are the challenges? Funding Sponsorship Indemnity Knowledge Local processes and national regulations Buy-in from sites Different practices
13 Funding Key issue can t run trial without money
14 Infrastructure Requires: 1 Local knowledge & support 2 Central coordination Achieve through: 1 Data Centres & National Coordinators 2 Coordinating Data Centre
15 Infrastructure DCs Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland European Osteosarcoma Intergroup (EOI) Belgium, Netherlands, UK Scandinavian Sarcoma Group (SSG) Denmark, Finland, Iceland, Norway, Sweden
16 Infrastructure DC roles Appointing National Coordinators Identifying legal entity to receive Sponsor s delegated roles National applications & submissions Funding Regulatory Ethics Patient info sheets & consent forms Group-specific protocol appendices Collection of data from trial sites
17 Infrastructure - CDC Need central coordination like in single Group trials Lead on common aspects Organise collaboration Improve communication Decrease duplication of tasks
18 Infrastructure Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland Coordinating Data Centre European Osteosarcoma Intergroup (EOI) Belgium, Netherlands, UK Scandinavian Sarcoma Group (SSG) Denmark, Finland, Iceland, Norway, Sweden
19 CDC roles before start Coordinate Trial Management Group (TMG) Lead protocol development Protocol body Common appendices Sponsorship Registration on trial databases Trial website Lead agreements between Groups Lead negotiations & contracts with Pharma
20 CDC roles before + during Randomisation lists and systems Accrual and data reports Monitoring of data Monitoring of trial sites Pharmacovigilance
21 CDC roles during + after Lead on data collection Define common dataset Produce data flow protocol Centrally compile data from Data Centres Coordinate oversight committees Trial Management Group (TMG) Trial Steering Committee (TSC) Independent Data Monitoring Committee (IDMC) Lead on analyses
22 EURAMOS groups + structure USA Canada Australia Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland Germany Hungary Switzerland Austria New Zealand Czech Rep Coordinating Data Centre: MRC Clinical Trials Unit, UK UK Denmark Belgium European Osteosarcoma Intergroup (EOI) Scandinavian Sarcoma Group (SSG) Finland Netherlands Belgium, Netherlands, UK Denmark, Finland, Iceland, Norway, Sweden Norway Eire Sweden
23 Infrastructure & Delegation EU Sponsor can delegate some roles CDC can delegate some roles
24 EURAMOS groups + structure USA Canada Australia Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland Germany Hungary Switzerland Austria New Zealand Czech Rep Quality of Life Centre: Düsseldorf Germany Coordinating Data Centre: MRC Clinical Trials Unit, UK Intergroup Safety Desk: KKS Münster Germany UK Denmark Belgium European Osteosarcoma Intergroup (EOI) Scandinavian Sarcoma Group (SSG) Finland Netherlands Belgium, Netherlands, UK Denmark, Finland, Iceland, Norway, Sweden Norway Eire Sweden
25 EURAMOS groups + structure USA Canada Australia Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland Germany Hungary Switzerland Austria New Zealand Czech Rep Quality of Life Centre: Düsseldorf Germany Coordinating Data Centre: MRC Clinical Trials Unit, UK Intergroup Safety Desk: KKS Münster Germany UK Denmark Belgium European Osteosarcoma Intergroup (EOI) Scandinavian Sarcoma Group (SSG) Finland Netherlands Belgium, Netherlands, UK Denmark, Finland, Iceland, Norway, Sweden Norway Eire Sweden
26 Sponsorship and agreements Intergroups as collaborations If no legal existence can t sponsor or sign contract Assigning Sponsor MRC (UK) for EU COG (USA) for North America Confirmation of Sponsor Development of agreements Planned for Sponsor in each country Legal entity in place as local delegate
27 Major agreements & contracts MRC 4 COG (European Sponsor) (North American Sponsor) 1 2 Schering Plough 3 (Integrated Therapeutics Group Inc) European countries + DCs + safety desk + QL centre (EURAMOS framework agreement) European Trial Framework Agreement
28 EURAMOS groups + structure USA Canada Australia Children s Oncology Group (COG) USA & Canada Cooperative Osteosarcoma Study Group (COSS) Austria, Germany, Hungary, Switzerland Germany Hungary Switzerland Austria New Zealand Czech Rep Quality of Life Centre: Düsseldorf Germany Coordinating Data Centre: MRC Clinical Trials Unit, UK Intergroup Safety Desk: KKS Münster Germany UK Denmark Belgium European Osteosarcoma Intergroup (EOI) Scandinavian Sarcoma Group (SSG) Finland Netherlands Belgium, Netherlands, UK Denmark, Finland, Iceland, Norway, Sweden Norway Eire Sweden
29 Funding How to ensure fair and representative funding for central and local infrastructure? EURAMOS funded through ESF Part of ECT-EUROCORES Distributed funding National funders Central support ESF
30 Oversight bodies Trial Management Group TMG Day-to-day running Trial Steering Committee TSC Oversight Independent Data Monitoring Committee IDMC Review of accruing data
31 Sponsors Funder DMC: Data Monitoring Committee DMC feedback to TSC & TSC response to DMC via CDC TSC: Trial Steering Committee Report from Trials Unit Report from Trials Unit Question & Feedback CDC [EISD] [DC] Question & Feedback TMG: Trial Management Group = Trial expert panels = Data Centres = National Coordinators = Participating Centres
32 International collaborations RCTs are feasible in rare diseases Requires collaboration Collaboration is achievable EURAMOS is one model
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