Barriers and Facilitators to Clinical Trial Research in Australia Google images 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 Courtesy J Simes

4 Cancer trials in Australia: 2006 – 2102 Industry vs. non-industry trials Number of new trials registered each year with Australian sites Courtesy J Simes

5 Cancer trials in Australia: 2006 – 2102 Small versus larger trials Number of new trials registered each year with Australian sites 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 Review What 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 $ 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