Upload
informa-australia
View
177
Download
0
Tags:
Embed Size (px)
DESCRIPTION
Nik Zeps delivered the presentation at the 2014 Genomics in Healthcare Conference. The Genomics in Healthcare Conference 2014 explored the current uses of genomics and forecast the potential for the discipline. Supported by the Garvan Institute of Medical Research who aim to further the use of genomic information in healthcare, the conference covered the policy, economics, legal and social aspects of genomics. For more information about the event, please visit: http://bit.ly/genomics14
Citation preview
Oct 29th 2014
Adj Prof Nik ZepsDirector of Research, Subiaco Hospital
Managing the practical and regulatory issues at the interface between genomics research and practice
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
2
Why do Health and Medical Research?
Effective and efficient Healthcare is founded upon evidence created by research
Improvements in healthcare delivery can only be achieved through research
Research is therefore integral to healthcare delivery
4
$5 billion
Key Points
• Addressing the silent and prohibitively expensive epidemic of unwarranted variation in healthcare, is an urgent imperative for Governments and for the payers and providers of healthcare.
• The strategy to reduce unwarranted variation in healthcare must include the infrastructure necessary to systematically – IDENTIFY unwarranted variation– INTERPRET unwarranted variation– RESPOND to unwarranted variation
7
• The systematic identification, interpretation and response to unwarranted variation requires a ‘self-improving’ healthcare system. Such a system combines – - the accurate collection of treatment and outcome data, – - the capacity to analyse these data to provide meaningful
feedback to clinicians and providers, and – - the capacity to undertake robust clinical trials that
provide definitive answers to important clinical questions that arise from understanding these variations
Inter-disciplinary Approach
With permission- Steve Webb. Blood CRE
Research vs Clinical practice
Key elements to delivering genomics in healthcare
12
Insti
tutio
nal
Com
mitm
ent
Platforms
Workforce
Governance
R&D
Platforms• Pathology
– Which technologies?• More try to cover = more expensive
– Currently costs exceed revenue• What is practically useful?• Information Services
– Can’t cope with large file transfer and storage– Lack of informatics in service
• Dizzying number of ways to analyse the data even from targeted panels
Workforce
• Need skilled pathology workforce– Clinical and technical (bioinformatics)
• Ensure those requesting the tests do so properly
• How to interpret results clinically– Are they useful?
Governance
• Is genomics different?
• Already have a robust NPAAC/NATA/RCPA framework
Ethical issues
• Cost of test(s)– Personal and community
• Availability of any intervention• Counselling requirements
– Including extended family• Disclosure of incidental findings (ACMG)
Consent and ethical approvals
• Revision to NS 3.4 finalised December– 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
– Comments on pathology uses
TTR
• All elements of genomic medicine are an opportunity for TTR– How do we manage interface between clinical
practice and research? – Are all patients research patients?
• Yes
• Who can teach/supervise our medical graduates/undergraduates?
SJG HealthCare Strategic Objective
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?
comments
• “Well, it’s of no concern to me” (#18); “• . . . I don’t care . . . its not much good to me” (#16); • “. . . was a no brainer” (#15); • “. . . I couldn’t care less; it doesn’t bother me at all” (#14);• “. . . no problems, I didn’t blink” (#13); • “It didn’t worry me at all” (#12); • “. . . it wasn’t an issue” (#11); • “. . . I’m surprised they even asked” (#10); • “. . . they want it they can have it . . . its no good to me” (#5); • “I didn’t even think anymore about it” (#4);• “. . . I just went with the flow” (#3); • “. . . it was a routine thing . . . there’s no big deal . . . it was no skin off my
nose” (#1).
Health informatics
• Registries have existed for a long time• Genomics simply adds a new set of fields
(albeit complex)• Genomic Research is underpinned by excellent
clinical phenotyping
ACTA’s Membership
ACTA
Clinical Trials Networks
Clinical Quality Registries
Clinical Trial Coordinating
Centres
ACTA’s Vision
ñ That all patients who require treatment for which there is
uncertainty about the most effective therapy have the opportunity to participate in high quality clinical trials.
ñ That the best evidence informing optimal heath care is based on well conducted controlled trials of the effect of interventions on clinically relevant outcomes.
Genomics in health
• Is here• Is not exceptional• Must be managed within existing frameworks• Requires commitment by funders and policy
makers to implement properly