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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
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