CLINICAL TRIALS in AUSTRALIA

COSA 37TH

ANNUAL SCIENTIFIC MEETING

MELBOURNE –

10 November 2010

Professor Jim Bishop AOChief Medical Officer

Australian Government Department of Health and Ageing

Health Expenditure per capita, public and private expenditure, OECD countries, 2008 ($US PPP)

7538

5004

4627

42104079 4063 3970

3793 3737 3696 36773540 3470

3359 33533129 3060 3008 2902 2870

2729 2687 2683

2151

1801 1781 1737

14371213

999852 767

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

1. Refers to insured population rather than resident population. 2. Current expenditure. 3. 2006. 4. 2007. Source: OECD, OECD Health Data, June 2010

Public expenditure on health Private expenditure on health

OECD HEALTH DATA 2010How Does AUSTRALIA Compare

AUSTRALIA’S RANKING AMONGOECD COUNTRIES 1987-2006

Source: AIHW Australia’s Health 2010

Projected Burden of Major Disease Groups, 2010

Source: AIHW Australia’s Health 2010

ALL CANCER –

MORTALITY/INCIDENCE

ratios for selected countries -

2008

Source: IARC 2010.

0.0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1.0

Kenya

Nigeria

Egypt

Viet N

amTurk

eyInd

iaChinaRuss

iaSou

th Afric

aGreec

eBraz

ilJa

pan

Czech

Rep

ublic

Italy

United King

domCana

daGerm

any

Sweden

New Zealan

dUSA

Austra

liaM

orta

lity-

to-in

cide

nce

ratio

MalesFemales

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

0.0 2.0 4.0 6.0 8.0

Tobacco

Blood pressure

Overweight/obesity

Physical inactivity

Blood cholesterol

Alcohol

Fruit/vegetables

Illicit drugs

Air pollution

Unsafe sex

% DALYs

Total of 32%

Source: Table 4.1 AIHW Australia’s Health 2008

AUSTRALIA’S RANKING AMONGOECD COUNTRIES 1987-2006

Source: AIHW Australia’s Health 2010

OVERWEIGHT & OBESTITY

Source: AIHW: Australia’s Health 2008

Increased Risk Body Fatness OesophagusPancreasColorectalBreast (PM)Endometrum

Abnormal Fatness Colorectal

Reduced Risk Physical exercise Colon

Source:World

Cancer Research Fund: Food, nutrition, physical activity and prevention of cancer, 2007

OBESITY and CANCER

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)

Budget 2010-11

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 controlledelectronic 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)

SUPPORTS FOR CLINICAL DECISION MAKING

Evidence Base

Highest Impact

Range of best practice tools

Successful implementation methods

Monitor and report

CLINICAL GUIDELINES

CLINICAL GUIDELINESHighest 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

2050Program Grants

61

Fellowships

391Career Development

264

Early Career (Aust)

347Early Career (O/s)

211

At 168 Institutions

1273

Project Grants -

Success Rates

27%21%21%22%22%23%23%30%

27% 23%

3344

48%42%

40%36%34%34%36%37%

49%

58%

37%

39%

42%43%41%

33%

44%

25%24%

19%

0

400

800

1200

1600

2000

2400

2800

3200

3600

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010Year of Application

Num

ber o

f app

licat

ions

Not recommended for funding (score < 4)

Fundable, but not funded

Funded

NHMRC Supported

Research Workforce

0

2 0 0 0

4 0 0 0

6 0 0 0

8 0 0 0

1 0 0 0 0

NH

MR

C S

uppo

rted

Wor

kfor

ce

2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0

F ull Tim e P art 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

$0

$10

$20

$30

$40

$50

$60

$70

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Mill

ions

0

50

100

150

200

250

300

Total Expenditure Number of Grants

NHMRC Project Grants

Clinical Trials Expenditure

Harmonization of Multi-centredEthical Review (HoMER)

National Statement for Ethical Conduct of Human Research (2007)

Process supported by AHMAC conducted by NHMRC

Certification of ethical review processes –

first roundRoles, responsibilities, templates publishedNHMRC working with States and Territories

TGA: CTX and CTN

2007/08

27922008/09

2986

Clinical Trials –

Gov

Cancer and

922Australia

WHO International

Cancer and

721Australia

ANZCTR Cancer 588( Total 4592 : 13% cancer)

AUSTRALIAN CLINICAL TRIALS

CANCER PUBLICATIONS

Australia

Growth* World

AustralianShare

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 cancerResearch and research information will drive

improvement Integration of research findings into daily practice

is everybody’s businessRole 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