Sustainability of Canadian biorepositories: Status, needs and national initiatives
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1 Sustainability of Canadian biorepositories: Status, needs and national initiatives Dr. Brent Schacter Principal Investigator, CTRNet Professor, Department of Medicine, University of Manitoba/CancerCare Manitoba Dr. Peter Watson Co-investigator, CTRNet Director, BC Cancer Agency Tumour Tissue Repository and Professor & Director University of BC Office of Biobank Education & Research
2 I. Biorepository landscape in Canada
3 CTRNet s mission: To enhance the capacity and quality of biobanking through standardization and improvement of biobanking processes and frameworks Origins Established fall 2004 Six founding programs Funded by ICR-CIHR Focus Enhance access for research Promote national standards Provide education and training
4 Organizational structure Management Committee Dr. Brent Schacter Dr. Anne-Marie Mes-Masson Dr. Peter Watson Dr. John Bartlett Dr. Kathryn Graham Dr. Randy Johnston Dr. Leigh Murphy Dr. Lois Shepherd Dr. Suzanne Vercauteren Dr. Dominique Trudel External Advisory Committee Two Node Province Single Node Province
5 CTRNet priorities in phase I Standard Operating Procedures (SOPs) 46 SOPs and 10 policies for management and operation of biobanks (available in English and French). Over 15,000 file downloads from over 80 countries worldwide. Advanced Tissue Management (ATiM) software Development of a standardized tissue accessioning and annotation tool to strengthen individual banks and to enable creation of a virtual network. Web Catalogue & Portal Virtual stock catalogue to enhance research access ~4000 unique visitors logged annually worldwide. Interfaces with the ATiM software and the SOP and Policy archive, providing a single site for the entire research community
6 CTRNet node summary Node Biospecimen types (primary*, aliquots**, derived***) Projects supported annually Cases released annually Biospecimens released annually 1 All of the above Derived products All of the above Derived products Derived products 40 3, All of the above *Primary samples (e.g., plasma, buffy coat, whole tissue blocks) **Aliquots (e.g., tissue sections) ***Derived products (e.g., RNA, DNA, proteins)
7 Major financial contributors to CTRNet biorepositories Node Coverage by host institution Coverage by non-profit Foundation Coverage by grants Coverage by user fees 1 70% 24% - 6% 2 88% - 10% 2% 3 80% - 10% 10% 4 20% 78% - 2% 5 15% 30% 50% 5% 6 75% %
8 Canadian biorepositories are diverse in design and function focus participants designs Category Characteristics Total Biobanks Total Personnel Mono-user Collection related to single studies or research laboratories and intended for a single primary research question and sometimes stored for secondary questions. Usually small scale. 8,000 16,000 Oligo-user Collection related to research groups and intended for a series of primary research questions and also planned for secondary questions within the laboratory or group. 2,000 6,000 Poly-user Collection related to a formal biobank to support multiple research studies and intended for many and diverse research questions. Usually large scale Total ~10,000 ~22,400
9 Assessing the role of user fees Survey of the biobank community in fall 2013: To gain an understanding of the processes that Canadian biobanks were using when biospecimens and/or data are released to research users. To assess whether the principles in the related CTRNet Policies/SOPs are complete and to identify areas where there are needed improvements/updates. Electronic survey 15 questions Distributed to 45 individuals (PIs/Directors and Leaders/Managers)
10 Baseline results Length of operation More than 5 yrs 1 to 5 yrs Less than 1 yr Have you released biospecimens and/or data? Yes - more than 5 yrs Yes - 1 to 5 yrs Yes - less than 1 yr Not yet
11 The role of user fees in Canada Does your biobank have a set fee schedule or pricing guide for accessing materials? Yes, set prices or ranges are established No, fees are determined on a case by case basis Just shipping costs Not yet determined Does your biobank have different fees for Canadian vs. international applicants? Yes No Not applicable (Not yet determined; release is only to internal projects)
12 To what percentage do fees cover actual costs? 100% 50% to 75% 25% to 50% less than 25%
13 II. Needs and initiatives in Canada
14 Dimensions of sustainability Financial value Social acceptability Operational efficiency
15 Dimensions of sustainability Financial value Social acceptability Operational efficiency Biobank types Risks Stakeholders
16 Strategies for sustainability
17 CTRNet strategies and tools to address sustainability
18 Biobank certification processes Mono Founded on education program with a focus on the why best practices and SOPs Scaled & applicable to all entities conducting biobanking Targeted to address biospecimen quality (standards) and governance (risk) Poly CTRNet CAP ISO Oligo Launched spring 2013: >54 biobanks enrolled
19 CTRNet Biobank Resource Center Certification programs Other biobanks in Canada International biobanks Education materials Online modules Online training demos Workshops Services & Tools Consulting services: business & operational plans Templates: governance, operations, facilities etc. Tools: biospecimen reporting and User fee calculator Strategies: Patient engagement/enrolment program Patient Engagement Strategy
20 Patient engagement in clinical research strategy Feasibility tested >10,000 patients enrolled Operating costs established ($1 - $20 per PTC) Pre-procedure/ intervention Diagnosis Procedure and Therapies Follow-up Permission to Contact Post-procedure/ intervention Research Programs Multiple benefits established Acceptability (broad opportunity engages patients and health staff) Efficiency (reduces research costs and accelerates projects) Enrolment (proven staff & training value and expanded public support) Preliminary interview Consent interview Pathology 1. Permission to Contact Preliminary interview Consent interview Clinical studies Biobank Broad value of PTC recognized Provincial business plan under development National program under consideration with clinical trials initiative 2. Collection of a minimal set of personal data to allow future contact 3. Access to health records for the limited purpose of prescreening for eligibility
21 Biobank user fee calculator: the model Goals Establish ethically based user fees Educate on total costs Harmonize user fees
22 Biobank user fee calculator: the model Observations Estimates show wide variation Calculated user fees are always higher Calculated user fees show convergence
23 What does sustainability really look like? people BC Cancer Agency Tumor Tissue Repository Clinic / Diagnosis ( large, polyuser, institutional biobank) Retrospective questions Research Hospital / Surgery Open access BCCA Clinic Chart / Follow-up Prospective questions SOP driven processes Expert team people
24 $ (thousands) Ideal/anticipated scenario Setup Building Maintenance 1, Program operating costs Core biobank support Services
25 $ (thousands).. Real Life Setup Building Maintenance 1, Program operating costs Core biobank support Services
26 $ (thousands) & # consents Primary focus in years 1-2 Increase accrual 1, Program operating costs Core biobank support consents
27 $ (thousands) & # consents Primary focus by years 3-5 Increase Internal efficiency 1, Program operating costs Core biobank support consents
28 $ (thousands) & # consents Primary focus by years 6-7 Increase enrollment efficiency and increase release 1, Program operating costs Core biobank support consents Services
29 $ (thousands) & # consents Primary focus by years 8-9 Establish targets, protect accrual capability, generate new services 1, Program operating costs Core biobank support consents Services
30 $ (thousands) & # consents Primary focus by years Develop and Expand services 1, Program operating costs Core biobank support consents Services
31 TTR Services The BC Cancer Agency's Tumor Tissue Repository (TTR) & UBC Office of Biobank Education and Research (OBER) Dr. Peter Watson Director Sheila O Donoghue Project Manager/ Biobank Leader BCCA-TTR Lise Matzke Project Manager/ Biobank Design Stefanie Cheah Project Manager/ Permission to Contact Candace Carter Project Manager/ Advisor Simon Dee IT Analyst Jodi LeBlanc Consent Nurse Sindy Babinszky Biobank Lab Supervisor Services Case release (biospecimens & data) Tissue analysis (IHC & TMA scoring) Prospective study support (consenting & accrual) Permission to contact release (PTC) Biobank services (local training, IT and biobank support, etc.)
32 Accrual Internal metrics Stock RNA quality 100% 80% 60% 40% Mod Exc 20% 0% #1 #2 #3 #4 #5 #6 #7 #8 #9
33 External metrics Metrics & Benchmarking TTR Total Applications >35 TTR 2012 Other 2012 Biospecimens released 3720 Data records compiled 2514 Studies supported Cases distributed Publications supported
34 External metrics TTR Total Applications >35 Response time 60 days Biospecimens released 3720 Patients engaged >10,000 Data records compiled 2514 Services provided >20 Metrics & Benchmarking TTR 2012 Other 2012 Studies supported Cases distributed % of Inventory used 22% 10% 8% Publications supported Cum 5 yr Impact Factor
35 Overall impact Knowledge gained Patient Engagement Public Impact clinical scien fic pa ent societal Personnel trained Studies supported Publications generated Patients enrolled Research donor support Research opportunities enabled Impact on practice societal recognition
36 Contacts CTRNet main site CTRNet Biobank Resource Centre Funders Partners
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