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CLINICAL TRIALS in AUSTRALIA



  COSA 37TH ANNUAL SCIENTIFIC MEETING


        MELBOURNE – 10 November 2010

                Professor Jim Bishop AO
                  Chief Medical Officer
 Australian Government Department of Health and Ageing
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
AUSTRALIA’S RANKING AMONG
  OECD COUNTRIES 1987-2006




                Source: AIHW Australia’s Health 2010
Projected Burden of
                                       Major Disease Groups, 2010




Source: AIHW Australia’s Health 2010
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.
                                    ge
                                      ria
                                  Eg
                                     yp
                              Vi        t
                                 et
                                    Na
                                       m
                                 Tu
                                   rk
                                     ey
                                   In
                                      di
                                          a
                                  Ch
                                      in
                                          a
                                 Ru
                         So         ss
                             ut         ia
                                h
                                  Af
                                     ric
                                          a
                                G
                                  re
                                     ec
                                          e
                                  Br
                                     az
                                          il
                     Cz           Ja
                        ec           pa
                            h             n
                              Re
                                  pu
                                      bl
                                         ic
                     Un
                        ite         Ita
                           d             ly
                              Ki
                                 ng
                                   do
                                        m
                                Ca
                                   na
                                       da
                              G
                                er
                                   m
                                     an
                               Sw y
                         Ne        ed
                             w         en
                                Ze
                                   al
                                      an
                                          d
                                    US
                               Au      A
                                                                                                                               ratios for selected countries - 2008




                                 st
                                    ra
                                         lia
                                                                                                                 Males
                                                                                                       Females
                                                                                                                           ALL CANCER – MORTALITY/INCIDENCE
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 – Cancer Institute NSW
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
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 Australia’s Health 2008
AUSTRALIA’S RANKING AMONG
  OECD COUNTRIES 1987-2006




               Source: AIHW Australia’s Health 2010
OVERWEIGHT & OBESTITY




            Source: AIHW: Australia’s Health 2008
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
Budget 2010-11

Anti-smoking campaigns ($27.8m)

COAG agreed
• Increased tobacco excise
• Plain packaging
• Restricting internet advertising of tobacco products
• Further funding for National Binge Drinking Strategy
  ($50m)
• Survey of Australia’s Health ($54m)

   National Preventative Health Agency (Spring Session)
NATIONAL PREVENTATIVE
                                         HEALTH AGENCY


• Builds on the National Partnership Agreement on
  Preventative Health ($872.1m over 6 years)
• Establishment and operational by early 2011 ($17.6m)
• 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)
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
Commonwealth Government Health and
 Hospital expenditure under the NHHN




           Source: Commonwealth Budget Papers, DOHA and PMC Analysis
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 – multi disciplinary teams
    (100% Federal Funds)
BUDGET 2010-11


e-Health – connecting patients, providers and information
   systems

The Government will establish a personally controlled
electronic health record system ($466.7m)

The system will:
• Enable people – 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.
• Allow people to register online to establish a personally
  controlled electronic health record from 2012-13
• Rigorous governance
• Privacy maintained
HEALTH REFORM


        KEY NEW STRUCTURES


   National Performance Authority
   Independent Hospital Pricing Authority
   Expanded Australian Commission of
    Safety and Quality in Health Care
    (ACSQHC)
CLINICAL GUIDELINES

    SUPPORTS FOR CLINICAL
      DECISION MAKING


   Evidence Base
   Highest Impact
   Range of best practice tools
   Successful implementation methods
   Monitor and report
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
NON-COMMERCIAL CANCER
RESEARCH EXPENDITURE, 2004
      (A$ per CAPITAL)




             Source: Eckhouse et al (2007), ABS
NHMRC STRAGEGIC PLAN
       2010 -12
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
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
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
NHMRC Support for National
  Health Priorities Areas
Percentage of Expenditure by Broad
   Research Area (2000 and 2010)
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
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
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
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 – first round
 Roles, responsibilities, templates published
 NHMRC working with States and Territories
AUSTRALIAN CLINICAL TRIALS




TGA: CTX and CTN        2007/08           2792
                        2008/09           2986

Clinical Trials – Gov   Cancer and         922
                         Australia

WHO International       Cancer and          721
                         Australia

ANZCTR                  Cancer              588
                        ( Total 4592 : 13% cancer)
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
CANCER CARE IN THE FUTURE
 Increasing burden of cancer
 Research and research information will drive
  improvement
 Integration of research findings into daily practice
  is everybody’s business
 Role delineation, sizing enterprises for function
  and multidisciplinary research interactions
  remain a major challenge
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

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Clinical Trials in Australia

  • 1. CLINICAL TRIALS in AUSTRALIA COSA 37TH ANNUAL SCIENTIFIC MEETING MELBOURNE – 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
  • 3. AUSTRALIA’S RANKING AMONG OECD COUNTRIES 1987-2006 Source: AIHW Australia’s Health 2010
  • 4. Projected Burden of Major Disease Groups, 2010 Source: AIHW Australia’s 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. ge ria Eg yp Vi t et Na m Tu rk ey In di a Ch in a Ru So ss ut ia h Af ric a G re ec e Br az il Cz Ja ec pa h n Re pu bl ic Un ite Ita d ly Ki ng do m Ca na da G er m an Sw y Ne ed w en Ze al an d US Au A ratios for selected countries - 2008 st ra lia Males Females ALL CANCER – 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 – 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 Australia’s Health 2008
  • 9. AUSTRALIA’S RANKING AMONG OECD COUNTRIES 1987-2006 Source: AIHW Australia’s Health 2010
  • 10. OVERWEIGHT & OBESTITY Source: AIHW: Australia’s 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 • Increased tobacco excise • Plain packaging • Restricting internet advertising of tobacco products • Further funding for National Binge Drinking Strategy ($50m) • Survey of Australia’s Health ($54m) National Preventative Health Agency (Spring Session)
  • 13. NATIONAL PREVENTATIVE HEALTH AGENCY • Builds on the National Partnership Agreement on Preventative Health ($872.1m over 6 years) • Establishment and operational by early 2011 ($17.6m) • 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 – multi disciplinary teams (100% Federal Funds)
  • 17. BUDGET 2010-11 e-Health – connecting patients, providers and information systems The Government will establish a personally controlled electronic health record system ($466.7m) The system will: • Enable people – and their chosen health provider - to access online their key health information when and where it is needed, for their care across the health system. • Allow people to register online to establish a personally controlled electronic health record from 2012-13 • Rigorous governance • Privacy maintained
  • 18. HEALTH REFORM KEY NEW STRUCTURES  National Performance Authority  Independent Hospital Pricing Authority  Expanded Australian Commission of Safety and Quality in Health Care (ACSQHC)
  • 19. CLINICAL GUIDELINES SUPPORTS FOR CLINICAL DECISION MAKING  Evidence Base  Highest Impact  Range of best practice tools  Successful implementation methods  Monitor and report
  • 20. CLINICAL GUIDELINES Highest Impact  Greatest Burden of disease  Greatest harm from poor practice  Greatest demonstrated need: - New Standard of Care - Proven variation in practice  Greatest time spent/cost to health system
  • 21. NON-COMMERCIAL CANCER RESEARCH EXPENDITURE, 2004 (A$ per CAPITAL) Source: Eckhouse et al (2007), ABS
  • 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
  • 26. NHMRC Support for National Health Priorities Areas
  • 27. Percentage of Expenditure by Broad Research Area (2000 and 2010)
  • 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 – 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 – 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 everybody’s 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