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Clinical Trials in Australia
1. CLINICAL TRIALS in AUSTRALIA
COSA 37TH ANNUAL SCIENTIFIC MEETING
MELBOURNE โ 10 November 2010
Professor Jim Bishop AO
Chief Medical Officer
Australian Government Department of Health and Ageing
2. OECD HEALTH DATA 2010
How Does AUSTRALIA Compare
Health Expenditure per capita, public and private expenditure, OECD countries, 2008 ($US PPP)
8,000
7538
7,000
6,000
5004
5,000 4627
4210
4079 4063
3970
4,000 3793 3737
3696 3677
3540 3470
3359 3353
3129 3060
3008
2902 2870
3,000 2729 2687 2683
2151
2,000 1801 1781 1737
1437
1213
999
852
1,000 767
0
1 Refers to insured po pulatio n rather than resident po pulatio n. 2. Current expenditure. 3. 2006. 4. 2007. So urce: OECD, OECD Health Data, June 201
. 0
Public expenditure on health Private expenditure on health
4. Projected Burden of
Major Disease Groups, 2010
Source: AIHW Australiaโs Health 2010
5. Mortality-to-incidence ratio
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Ke
ny
a
Ni
Source: IARC 2010.
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Br
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Cz Ja
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Ca
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Sw y
Ne ed
w en
Ze
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US
Au A
ratios for selected countries - 2008
st
ra
lia
Males
Females
ALL CANCER โ MORTALITY/INCIDENCE
6. 5 YEAR SURVIVAL RATES 2004
NSW SEER
Non small cell lung 13% 14%
Colon 65% 67%
Rectum 66% 69%
Breast Cancer 89% 90%
Lymphoma (DL) 53% 53%
Source: Tracey et al โ Cancer Institute NSW
7. MILESTONES IN
CANCER CONTROL
๏ Public health measures in smoking reduction,
screening breast, cervix, bowel, health literacy
๏ Adjuvant treatment of breast, lung and bowel cancer
๏ New anti-cancer drugs and symptom control drugs
๏ Cancer research translated into practice
๏ Cancer registries, data linkage and analysis
8. THE KEYS TO PREVENTION
Tobacco
Blood pressure
Overweight/obesity
Physical inactivity
Blood cholesterol
Alcohol
Fruit/vegetables
Illicit drugs
Air pollution Total of 32%
Unsafe sex
0.0 2.0 4.0 6.0 8.0
% DALYs
Source: Table 4.1 AIHW Australiaโs Health 2008
11. OBESITY and CANCER
Increased Risk Body Fatness Oesophagus
Pancreas
Colorectal
Breast (PM)
Endometrum
Abnormal Fatness Colorectal
Reduced Risk Physical exercise Colon
Source:World Cancer Research Fund: Food, nutrition, physical activity and prevention of cancer, 2007
12. Budget 2010-11
Anti-smoking campaigns ($27.8m)
COAG agreed
โข Increased tobacco excise
โข Plain packaging
โข Restricting internet advertising of tobacco products
โข Further funding for National Binge Drinking Strategy
($50m)
โข Survey of Australiaโs Health ($54m)
National Preventative Health Agency (Spring Session)
13. NATIONAL PREVENTATIVE
HEALTH AGENCY
โข Builds on the National Partnership Agreement on
Preventative Health ($872.1m over 6 years)
โข Establishment and operational by early 2011 ($17.6m)
โข Specific responsibilities:
- National Social Marketing ($102m over 4 years)
- Preventative Health Research fund ($13.1m
over 4 years)
- Preventative Health Workforce audits and
strategy ($0.5m over 2 years)
14. REGIONAL CANCER CENTRE PRINCIPLES
๏ Demonstrated need/impact
๏ Align with Cancer Services
๏ Link to Comprehensive Cancer Care
๏ Provide equitable and affordable access
๏ Address sustainability and workforce
๏ Support Clinical Research Networks
๏ Monitor and evaluate performance
15. Commonwealth Government Health and
Hospital expenditure under the NHHN
Source: Commonwealth Budget Papers, DOHA and PMC Analysis
16. HEALTH REFORM
๏ Increasing expenditure to $15 billion 2010/11
๏ Additional $7.3 billion over 4 years
๏ Local Hospital Networks (LHN) 60% Federal
Funds (60% of research and teaching)
๏ Medicare locals (100% Federal funds)
๏ GP Superclinics โ multi disciplinary teams
(100% Federal Funds)
17. BUDGET 2010-11
e-Health โ connecting patients, providers and information
systems
The Government will establish a personally controlled
electronic health record system ($466.7m)
The system will:
โข Enable people โ and their chosen health provider - to
access online their key health information when and where
it is needed, for their care across the health system.
โข Allow people to register online to establish a personally
controlled electronic health record from 2012-13
โข Rigorous governance
โข Privacy maintained
18. HEALTH REFORM
KEY NEW STRUCTURES
๏ National Performance Authority
๏ Independent Hospital Pricing Authority
๏ Expanded Australian Commission of
Safety and Quality in Health Care
(ACSQHC)
19. CLINICAL GUIDELINES
SUPPORTS FOR CLINICAL
DECISION MAKING
๏ Evidence Base
๏ Highest Impact
๏ Range of best practice tools
๏ Successful implementation methods
๏ Monitor and report
20. CLINICAL GUIDELINES
Highest Impact
๏ Greatest Burden of disease
๏ Greatest harm from poor practice
๏ Greatest demonstrated need:
- New Standard of Care
- Proven variation in practice
๏ Greatest time spent/cost to health system
23. NHMRC 2010
Project Grants 2050
Program Grants 61
Fellowships 391
Career Development 264
1273
Early Career (Aust) 347
Early Career (O/s) 211
At 168 Institutions
24. Project Grants - Success Rates
3600
3200
Number of applications
2800
19% Not recommended for
funding (score < 4)
2400 37%
24%
25%
2000
39% 3344
1600 58%
42% Fundable, but
44%
41% 43% not funded
48% 49%
33%
1200 42%
40%
800 37% 36%
36% 34% 34%
400 27% 27% 23%
21%
30% 23% 23% 22% 22% 21% Funded
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year of Application
25. NHMRC Supported
Research Workforce
10000
NHMRC Supported Workforce
8000
6000
4000
2000
0
2003 2004 2005 2006 2007 2008 2009 2010
F u ll Tim e P a rt Tim e
28. NHMRC Clinical Research
Total Expenditure 2008-2010
2008 2009 2010
Clinical Research No. Expend. No. Expend. No. Expend.
Scholarship,
Fellowships 300 $14.1M 294 $14.5M 283 $16.0M
Research (projects,
Programs) 552 $129.7 624 $156.9 655 $169.7
Total 852 $143.8 918 $170.5 938 $185.7
29. NHMRC Support for
Translational Research
Translational funding mechanisms
๏ Partnership Projects for Better Health
๏ Partnership Centres for Better Health
๏ Centres of Clinical Research Excellence
๏ Centres of Research Excellence in Population Health
Research, & Health Services Research
๏ National Health Research Enabling Capabilities Scheme
๏ Industry Development awards
30. NHMRC Project Grants
Clinical Trials Expenditure
$70 300
Millions
$60
250
$50
200
$40
150
$30
100
$20
50
$10
$0 0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Total Expenditure Number of Grants
31. Harmonization of Multi-centred
Ethical Review (HoMER)
๏ National Statement for Ethical Conduct of Human
Research (2007)
๏ Process supported by AHMAC conducted by
NHMRC
๏ Certification of ethical review processes โ first round
๏ Roles, responsibilities, templates published
๏ NHMRC working with States and Territories
32. AUSTRALIAN CLINICAL TRIALS
TGA: CTX and CTN 2007/08 2792
2008/09 2986
Clinical Trials โ Gov Cancer and 922
Australia
WHO International Cancer and 721
Australia
ANZCTR Cancer 588
( Total 4592 : 13% cancer)
33. CANCER PUBLICATIONS
Australia Growth* World Australian
Share
2000 1,881 5.6% 88,604 2.0%
2002 2,000 3.5% 97,035 2.1%
2004 2,514 19.0% 110.390 2.3%
2006 3,035 14.1% 125,934 2.4%
__________________________________________________________________
8 year period 17,917 70.4% 822,768 2.2%
__________________________________________________________________
* From pervious year
Source: Cancer Institute NSW 2008
34. CANCER CARE IN THE FUTURE
๏ Increasing burden of cancer
๏ Research and research information will drive
improvement
๏ Integration of research findings into daily practice
is everybodyโs business
๏ Role delineation, sizing enterprises for function
and multidisciplinary research interactions
remain a major challenge
35. CONCLUSIONS
๏ New health expenditure provides
opportunities for clinical trials
๏ New reform structures need evidence for
optimal interventions and guidelines
๏ HoMER supports further efficiency in trials
๏ Clinician and patient awareness of clinical
trials requires ongoing development