Report on the forum on a national approach to clinical trials

24 Jul 2006

The Forum brought together a broad cross-section of stakeholders involved in conducting clinical trials, including those agencies already working on a national approach, industry, researchers, ethics committee representatives, a patient group advocate and industry/state development departments. The aim of the Forum was to enhance the environment for clinical research in Australia, through supporting the development of a streamlined, national approach to clinical research.

The Pharmaceutical Industry Action Agenda (PIAA) Research and Development Taskforce (RDTF) presented the Forum with a “four pillar” model for analysing the global attractiveness of the clinical trial environment in Australia and identifying opportunities to improve it. The four pillars were quality, timeliness, value and capacity. The importance of maintaining the perceived quality of clinical research in Australia was discussed and stressed as clinical trials quality improves around the world and, in particular, in the fast growing markets in Asia, Europe and South America. Improvements in timeliness are crucial and efforts to streamline the ethical review process Australia are a very high priority. Value is a critical consideration for global decision makers and is more than just the direct the cost of the trial in Australia. Of great importance in considering value is the commercial environment for the resulting marketed drug and, to a lesser extent, government incentives for industry investment. Capacity includes both the absolute capacity to recruit patients and the relative capacity to produce data in niche areas, such as early phase clinical studies and hard-to-find study subjects.

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