Clinical Trials – Looking Forward

Clive Morris Head, Research Group

National Health and Medical Research Council

Largest single funder of Australian health and

medical Research, and the major funder of

cancer research, including research into

gynaecological cancers.

Research Funding

2009-10 2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 $-

$100,000.00

$200,000.00

$300,000.00

$400,000.00

$500,000.00

$600,000.00

$700,000.00

$800,000.00

$900,000.00

$703,065.00 $715,479.00 $746,075.00 $760,463.00 $774,227.00 $788,958.00 $804,165.00

Forward Estimates

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012$0

$20,000,000

$40,000,000

$60,000,000

$80,000,000

$100,000,000

$120,000,000

Clinical Trials Grant Funding

Project Grants 2000-2012

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 20120

400

800

1200

1600

2000

2400

2800

3200

3600

4000

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

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

42% 48% 49%

58%46%

52% 52%

33%41% 43% 44% 42%

39%

37%

25%24%

19% 30%

25%27%

Year of Application

Nu

mb

er o

f A

pp

licat

ion

s

Not fundable

Fundable, but not funded

Funded

Research expenditure in priority areas

Harmonisation of Multicentre Ethical Review

(HoMER)

– 43 Human Research Ethics Committees certified

– Governance and Monitoring handbooks

– Common forms and templates

– Guidance, policies and performance benchmarks

– http://hrep.nhmrc.gov.au/

National approach to single ethical

review

– Implementation of HoMER across states

and territories.

– Listing standard clinical trials items – now

with IHPA for pricing.

– www.australianclinicicaltrials.gov.au

– Clinical trials networks listed

Clinical Trials Action Group (CTAG)

Future Activities

• Last month the Australian Government announced a new initiative to build on the

previous CTAG-related work

• NHMRC role in supporting initiatives to improve clinical trial start up and

recruitment.

– Development of a clinical trials web portal

– Education and training across all sectors

– Improving research governance processes

• Better support for clinical trials networks

• NHMRC will continue to promote single ethical review via the National Approach to

Single Ethical Review (formerly ‘HoMER’)

Clinical Trials

http://www.australianclinicaltrials.gov.au/http://hrep.nhmrc.gov.au/