Australian government to overhaul clinical trials

The way clinical trials are approved and run will change with the federal government indicating it will accept the recommendations of the Clinical Trials Action Group released today.

According to the report, which was commissioned in October 2009, clinical trials are worth around $1 billion to the Australian economy each year, including around $450 million of foreign investment with Australia attracting trials from around the world.

However, the very increase in popularity of trials has placed a heavy burden on the infrastructure to approve, manage and monitor trials.

The report makes several key recommendations to improve the speed at which trials are approved, how they're monitored and how patients can be informed about current trials.

Minister for Health and Ageing Nicola Roxon and Innovation Minister Senator Kim Carr both voiced support of the report, and said the federal government has accepted the report's recommendations.

The report recommends a streamlined and nationally standardised ethical approval process that based on the National Health and Medical Research Council's (NHMRC) Harmonisation of Multi-centre Ethical Review (HoMER) scheme.

This scheme means a trial conducted at multiple locations only needs a single ethical approval rather than requiring ethical approval from each institution involved, even across multiple states.

The industry has sought a single ethical review for multi-location clinical trials for some time.

The report also makes a commitment to a single nationalised standard for how clinical trials receive governance approval according to NHMRC guidelines.

To expedite approvals, trial operators can pay an additional fee to have trials approved within 30 calendar days, with a standard maximum of 60 days for governance and ethical approvals.

Approvals for governance and ethics can also be conducted concurrently rather than contiguously as at present.

The cost of clinical trial approval will also be standardised across private and public organisations with the fee based on cost recovery principles rather than a blanket higher fee for privately run trials.

The government will also make an effort to better integrate clinical trials with e-health technologies, including patient records and data collection.

The report also recommends a new central web portal along the lines of the US's clinicaltrials.gov website for prospective trial patients to find out information about all trials being run in Australia and better facilitating patient recruitment.

The NHMRC will also work to improve communication and collaboration between institutions, academia and trial providers to help promote trials that serve an unmet medical need.

Other recommendations include better monitoring of the trials approval process and how these individual initiatives are being rolled out.

The Clinical Trials Action Group is an initiative of the Pharmaceutical Industry Working Group which is co-chaired by Ms Roxon and Senator Carr.