Nikolajs Zeps - St John of God HealthCare - How close are we to a Nationally Sustainable Model?

HOW CLOSE ARE WE TO A

NATIONALLY SUSTAINABLE

BIOBANKING MODEL?

A/Prof Nik Zeps

Disclosures

• Employer:

– St John of God HealthCare (Not for Profit)

– Department of Health of West Australia

– Department of Health of Australia • National Health and Medical Research Council

• Office of the Gene Technology Regulator

• Cancer Australia

• Received funds from

– Roche, Astra Zeneca, Pfizer, Merck Serono, CSL

• Member of

– ACTA, AGITG, COSA, ABNA, ISBER, ASMR, ICGC

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What is a biobank?

• A human biobank (also commonly referred to as a biorepository, repository, or tissue bank) is a collection of human biospecimens and their associated ‘annotating’ data.

• Are widely variable in respect to scale, activity and purpose.

– Databanks?

Developing a Strategy

• Who are the biobanks?

• What do they do?

• Who is responsible for running them?

• Who is responsible for funding them?

– How will they be funded?

• What does the research community need?

• What does the community want?

• What are the measures of success?

Issues Is there a shortage of specimens or is the issue one of knowing what is stored and being able to access them?

• Is all biobanking needed?

– That is, does a biobanking proposal meet a real medical need or is it simply a form of research that appeals to the proponent?

– How do we measure the benefits of biobanking? • BRIF?

• Grizzlism (Prof Pathology Alabama)

– Empty biobank a good biobank

– A firestorm is coming and we better brace for a change

Funding

• How should biobanks be funded?

– Block grant or provide funds through DRC?

• Can process change be equivalent to giving a grant?

– Evidence based processes

– Proportionate Risk based consent and ethics processes

– Informatics solutions?

Measures of success defined by NHMRC working group of funding agencies

• Number of samples accrued and distributed per year? – an output measure rather than an outcome measure

– poor indicator of the value of biobanking and should not be used.

• Primary outcome was improved healthcare/survival/wellbeing of the community – difficult to measure in a time frame that biobanks could report on.

• The utilisation of the biobank by researchers for quality research a clear output measure.

• Identify the outcomes measures of biobanks early and use to define baseline to evaluate effectiveness of the strategy

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Ownership/Access

McKeon Review

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Pathology services • Primary role is diagnosis

– Surgical resections – Biopsies – ‘Waste’ blood – Mortuary

• Legislated to keep samples for QA • Performance management means no money for

biobanking – Research not part of the new culture

• No consent • Academic pathology in decline • Often regarded as a ‘larder’ by researchers

Can we integrate into routine care?

• Yes

– SJOGHC since 2008

• Gynae, Breast and colorectal

• Part of the MDT

• Significant cost savings

• Governance more clear

• Clear mechanisms for maintaining relationships with donors

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Pathology Labs: Concerns

• Is there spare tissue?

– Early diagnosis

– Treatment

– Future need

• Can you have access to diagnostic samples?

– Who owns tissue?

– What are legal obligations?

Consent and ethical approvals

• Australia has well developed and sensible guidelines

– Revision to NS 3.4 will be finalised this year

– Sets out consent requirements

– Permits

• Broad consent

• Waiver of consent

• Low risk activity (including pathology QA/QC)

– Clearly defines

• Return of Result requirements

• Import/export

I have read the brochure entitled “WA Colorectal

Research Group”, and give my voluntary consent to the use of

my biological specimens and health information for medical

research as described therein.

Agree/Disagree (delete as appropriate)

Signed ________________

Name (printed)________________

Date ________________

• Written by consumers

• Donors interviewed generally

state “get on with it”

• What are barriers to use?

Consent for access to your medical records

• In addition to asking your permission to utilise some of your blood and tissue for research, we also need to ask your permission for access to identified health information kept about you that is relevant to medical research. Such medical records may originate from hospitals, General Practice records, diagnoses by private specialists you have seen in the past, and information that is held on you by the Department of Health or by the Commonwealth.

Confidentiality

• Your health information will be held in strict confidence at all times and will only be seen by authorized persons. Biospecimens will be identified by code only and it will not be possible for researchers using them to link this to your personal information themselves. The WACRG abide by all state and Federal Privacy legislation at all times.

• It is important to note that there may be circumstances where your medical information kept by the WACRG could be obtained through legal processes (such as a court order).

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Clinical data and follow up

• How comprehensive is it?

• How reliable is it?

• How long is follow up?

• Time to recurrence outside of a clinical trial is mythology

Databases

• Don’t need one master system

• Need Standardised data dictionaries

• Interoperability vs linkage

• Define reporting tools

• High level endorsement and support

• Compliance with Privacy regulations

What kind of plan can Australia adopt?

• Centralised

– Collect from local sites and send to hub

• Distributed

– Local nodes manage collection, processing and storage until required

• Networks

– Of independent biobanks

– Can only work if have informatic solutions

Don’t reinvent the wheel

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The Future (Said to CINSW 1st Dec 2010)

• Biobank consent should be routine for all new diagnoses of cancer

– Mandatory for clinical trials

• Work with pathology practices/RCPA to implement routine banking

• Re-engage pathology as equal partner in biobanking.

RCPA

• Developing a framework for biobanking that recognises the central role of pathology

– Molecular analysis increasing as part of diagnosis

– Will there be ‘spare’ tissue?

– Costs have not been traditionally covered for pathology services

– Need to harmonise consent/ethics for storage and use of biospecimens across practices