By Deb Borfitz
April 19, 2010 | Australia is in the process of reforming itself to better accommodate the clinical trials industry amidst competition from emerging markets in Eastern Europe, Latin America, and Asia. “In order to meet this challenge, we need to become more agile, particularly in study initiation and start-up,” says Joanne Andrews, project officer for the R&D Task Force (RDTF) of the Pharmaceuticals Industry Council, an umbrella organization with representation from industry associations and the Commonwealth Government.
The overarching goal of the RDTF is to “enhance the clinical trials industry…by influencing the external environment,” says Andrews. It is working in parallel with the government’s Clinical Trials Action Group that will formally recommend reforms to the Australian Government Ministers for Health and Innovation by the end of this month.
Performance measures for clinical trials, streamlined ethics approvals systems, national patient referral networks, and a strategic plan for the use of information and communications technology are among the areas expected to be addressed.
The situation, at present, is in no way dire. Australia has a solid pool of experienced clinical investigators, top-notch health care delivery and facilities, and a supportive government. Along with the U.S. and Europe, it is also at the forefront of technology, says Katie Viviers, general manager of Clinitec, which has an active R&D program in the area. Phase I-IV trials contribute $450 million annually to the national economy.
“In 2009, 7.8% of all industry-funded phase III trials registered on clinicaltrials.gov were conducted in part in Australia,” says Andrews. “We also have a healthy biotech sector focused on discovery and innovation.” The number of trials conducted here has stabilized and the number of investigative sites has increased. A study is underway to determine if Australia’s share of the global clinical trials industry has changed.
GlaxoSmithKline supported 80 clinical studies in Australia last year and in February made numerous recommendations to the Clinical Trials Action Group, including:
● Address the lack of educational opportunities for clinical research staff, which has resulted in a “poor rate of exposure in Australia to the latest advances in clinical trial and adaptive trial designs [that] have been adopted internationally.” Further workforce challenges include shortages of statisticians and trial coordinators.
● Establish a federal government body to support clinical research, applying lessons learned from initiatives in the United Kingdom and Korea. Another good practice example can be found in New South Wales, where a government initiative links sponsors, investigators and investors. Finland provides access to de-identified patient data from government sources for large scale phase IV trials.
● Standardize overhead costs and costs associated with clinical trial staff and trial coordination and better coordinate efforts to support clinical trials. Consider adoption of a “bank” nurse model of coordinators/investigators able to go where needed.
● Increase the capacity to do ethics reviews as well as the number of qualified scientific reviewers.
● Strategies to increase patient recruitment should incorporate a clinical trial awareness campaign, government encouragement of general practitioners to participate in trials or refer patients to them, nationally coordinated opt-in database for would-be trial participants, and support of peer support networks and not-for-profit, disease-specific groups. Further, the government could support trial participation by borrowing concepts utilized by the U.S.-based Center for Information and Study on Clinical Research Participation.
Pillars of activity by RDTF work groups are directed at quality, timeliness, value, and capacity, says Marisa Petersen, CEO of professional development association ARCS Australia Ltd and a member of the RDTF. The e-records group, for example, is tasked with ensuring that new developments in electronic health records meet the needs of clinical trials, including protocol feasibility and patient recruitment. “Opportunities are also being explored to establish a remote monitoring capability.”