Barriers and Facilitators to Clinical Trial Research in Australia

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Michael Friedlander

Background• Health care expenditure is growing faster than GDP $72 billion to $120 billion over last 10 years• Costs projected to triple over next 30 years

largely related to costs of treatment• Since 2008 the number of phase 3 trials have

reduced by 30-50%• Failure to recognise the potential cost savings

associated with clinical trials

3

Cancer trials in Australia: 2006 – 2012

Number of new trials registered each year with Australian sites

2006 2007 2008 2009 2010 2011 20120

50

100

150

200

250

CT.gov

ANZCTR

Trial Numbers

Courtesy J Simes

4

Cancer trials in Australia: 2006 – 2102Industry vs. non-industry trials

Number of new trials registered each year with Australian sites

1 2 3 4 5 6 70

20

40

60

80

100

120

Industry

Non Ind

Courtesy J Simes

5

Cancer trials in Australia: 2006 – 2102Small versus larger trials

Number of new trials registered each year with Australian sites

2006 2007 2008 2009 2010 2011 20120

50

100

150

200

250

Total

<100

100-500

>500

Courtesy J Simes

Disease Categories

Where are trials carried out?

Source of Funds

Set up in to recommend a 10 year health and medical research plan

McKeon ReviewWhat will it do for clinical trials ?

• Recommends embedding research in the health system and need to improve translational research

• Recommends streamlining clinical trial research- accelerate CTAG recommendations; standardise clinical trial pricing; improve recruitment

• Recommends an additional $50-100 million dollars p.a for non commercial trials which is great but clearly insufficient to improve level 1 evidence across all areas of medicine

Barriers

• Inadequate funding/resources• Failure by government-Federal and State to appreciate

the benefit of clinical trials to the country – cost savings as well as quality of care

• Pittance allocated to research and development when compared to Industry

• Low participation rates in clinical trials 5%• Withdrawal of funding for data manager/CTN in

regional/rural• Private hospitals and regional/rural centres

Barriers

• Funding mechanisms – annual grant – outcome 9 months later

• Lottery of the funding system- BMJ “Randomness in Funding”

• Competition with areas of basic research with more immediate results

• Grants 2- 5 years max.- don’t cover true costs• Per patient/site payments – collaborative vs. pharma• Ethics- HOMER- still only adopted in some states but not

all sites signed on and few private hospitals• Long delays in trial approval and initiation at sites- few

weeks to 6+months

Facilitators

• Allocate fixed % of NHMRC funding to clinical trials• Allocate % of health budget to comparativeness effectiveness

research• Support for infrastructure costs for Collaborative Groups• Increase trials capacity in public /private hospitals-link to KPI• Streamline ethics, governance and contracts• Improve timelines for approval• Smarter strategies of drug approval- approve use within a RCT

while further evidence obtained• Evolution of the peer review model /lottery• Adopt the NIHR model of funding from UK

“If clinical trials are the engine for change, the engine needs fuel and maintenance if it is going to continue to deliver improvement in care”

Professor John Zalcberg OAM