A3 – Streamlining Clinical Trials – The ARO perspective

This session explores the challenges today and in the future of conducting large randomised clinical trials and the value of the Academic Research Organisation (ARO) in this new environment including collaboration and partnership opportunities within the sector.

Australia and New Zealand have made major contributions to randomised clinical trials in cardiovascular medicine since the late 1980’s. Over this period, there has been major change in cardiac care globally. We have seen randomised clinical trials expand into Eastern Europe and more recently many parts of Asia. Australia and New Zealand contributed 10% or more of the global enrolment for large CV Phase 111 mega-trials and often boasted of sites listed in the top 10 for global recruitment. Our success was based in part on truly collaborative global partnerships and national networks of Investigators. Trial design was simple, with well thought out academic leadership developing both the protocol and trial methodology. More recently, with financial pressure on Industry we have seen a decline of large randomised clinical trials conducted in our region. Industry has looked to regions that are more cost efficient. In addition there is no growth in the number of trials conducted by Pharma globally. Containing and decreasing the total cost has been a major focus. The electronic CRF with data linkage to e-health records and large registries and efforts around risk based monitoring models show promise in other parts of the world. We are recognised for our relatively easy regulatory approval process. However Australia in particular has struggled with bureaucratic and administrative issues at the site level with lengthy delays to start up and FPI. Efforts have been made at the ethics review and approval level and significant efforts continue to be made at the governance level. Still more needs to be done. We wish to explore the challenges today and into the future of conducting large scale randomised clinical trials and the value of the Academic Research Organisation in this new environment including collaboration and partnership opportunities within the industry.

Chairpersons:Professor Phil Aylward, Flinders Medical Centre & Professor Ralph Stewart, GLCC Research