The governance of clinical trials in Australia is currently the matter of a major debate being coordinated by a subcommittee of the Pharmaceutical Industry Working Group, the Clinical Trials Action Group, co-chaired by the Hon. Richard Marles MP, Parliamentary Secretary for Innovation and Industry, and the Hon. Mark Butler MP, Parliamentary Secretary for Health. The Action Group has called for submissions related to improving the operating environment of clinical trials in Australia.

A major area of concern for the Action Group is the continued practice of duplication of ethical review of clinical trials being conducted across multiple sites. Significant inroads into reducing this problem have been made by individual states and the National Health and Medical Research Council (NHMRC) has commissioned the Harmonisation of Multicentre Ethical Review (HoMER) project in order to address this issue at a national level.

Despite progress there remains a significant concern that in pursuing a set of standards to be implemented at the state level that there will be insufficient incentive, and local funding, to maintain a nationally coordinated system. It is also unclear as to whether the HoMER system will manage to reform regulatory barriers that exist between the public health systems, Universities and the private healthcare sector. The latter has been a particular deficit of the implementation of single ethical review in New South Wales.

A second failing of the NSW single ethical review program has been insufficient allocation of resources to resolve issues related to uniform research governance. This problem has possibly resulted in longer rather than shorter overall time to approval for the conduct of clinical trials. This outcome has been heavily criticised in the medical press, however there must be acknowledgement that prior to the need for formal governance assessments much clinical research in Australia was conducted without the adequate legal and financial oversight required by the NHMRC and the Therapeutic Goods Administration (TGA). This issue is being addressed at the state level and by HoMER.

The greatest risk for the plans of the Action Group come from stakeholders that reject the proposed centralising reforms on the basis that the main lobbyists and beneficiary is the pharmaceutical industry. These stakeholders contend that existing systems are adequate and that more centralised ethical review processes reduce the protection of study participants.

The European Union (including the United Kingdom), the United States, New Zealand and several other countries have, or are developing, more centralised processes with no demonstrable reduction in ethical oversight of research. The HoMER system would incorporate accreditation of human research ethics committees, a process that should in time lead to minimal standards of oversight.

Harmonisation and centralisation of ethics and governance processes may allow saved resources to be mobilised for proper audit of trials activities; thus increasing participant protection.

The aims pursued by the Clinical Trials Action Group will benefit the pharmaceutical industry and the Australian economy, but these will not be the only benefits.

Improving equity of access to novel treatments for many diseases, whilst maintaining the highest ethical standards and scientific rigour should lead to improved healthcare for Australians.

The health of the clinical trials industry reflects that of the healthcare system: both can be reformed to mutual benefit.