Singapore, Jan 11, 2010: For the enhancement of Australia’s position as a preferred destination for clinical trials, on November 30, 2009, the Rudd Government’s Clinical Trials Action Group in Australia released discussion papers which will help to look for reforms to keep these trials in Australia against the emerging competition.
Public submissions are being sought by Clinical Trials Action Group that comprises Richard Marles, Parliamentary Secretary for Innovation and Industry and Mr Mark Butler, Parliamentary Secretary for Health, who co-chaired the Action Group. Other members of the Action Group, established by Kim Carr, Science Minister and Nicola Roxon, health minister on October 27, 2009, include: Professor Jim Bishop AO, Chief Medical Officer for the Australian Government, Dr Tim Dyke, Executive Director of the HoMER (Harmonization of Multicenter Ethical Review) project at the National Health and Medical Research Council, Mr Mitch Kirkman of Novartis Pharmaceuticals Australia and member of the former Pharmaceuticals Industry Strategy Group.
The Action Group’s discussion paper focuses on five key areas: (a) developing a clinical trials roadmap, developing key performance measures for clinical trials, (b) ensuring the rapid uptake of streamlined ethics, c. scientific and governance review processes, (d) strategies to improve patient recruitment and developing an information and (e) communications technology strategic plan for clinical trials.
Reacting to the release of the discussion papers, Ms Jennie Anderson, CEO, Evado said, “Many researchers in Australia have no awareness of what clinical trials technology can do. Unfortunately, there has been little industry education on the many benefits of electronic solutions versus paper or home-made databases for data collection.”
This is mainly because the National Health and Medical Research Council (NHMRC) in Australia at present do not allocate money for the purchase of clinical trial software associated with funded projects. This is a significant barrier to the uptake of electronic software solutions for NHMRC- funded trials and studies. Although federal and state funding is available for e-health applications, however, no funds are allocated for commercial sponsors or research institutes who wish to improve their productivity by implementing electronic clinical trial solutions.
Clinical trials software is seen as an expensive capital cost which lies outside the purview of grant funding. In reality, the purchase of EDC software would provide organizations with a technology platform for future trials and studies. It would also promote the use of information technology in clinical trials and studies, improvement of staff productivity and the quality of trial data.
There is a lack of awareness about new information and communications technology (ICT) and its benefits. Ms Anderson says, “Australia is falling behind the rest of the world in the uptake of electronic solutions for clinical trials. We are now losing the competitive edge in this billion-dollar global industry to countries that run trials at a lower cost with electronic data collection (EDC). Countries like the US, Korea and Singapore have embraced electronic data collection and management. Policy makers and researchers in these countries fully appreciate the productivity improvements and return on their investment.”
Sharing his views on the release of the discussion paper, Mr Mario Pennisi, CEO, Queensland Clinical Trials Network (QCTN), an independent association of entities involved in conducting clinical trials in Queensland says, “There is great interest in the recently announced forum, and of course, its eventual outcomes. Unfortunately, QCTN was not asked to be involved in this activity, and we believe that the constitution of the stakeholders involved in the group is limited, and heavily biased to ‘big pharma’ and as such will tend to only see the issues in that light. And whilst that is important, I believe it reflects lack of acknowledgement of where the Australian industry is at—and where it fits in the global sense.”
“We acknowledge that particularly for later phase studies, there is a strong case for the use of technologies such as EDC—this is a fairly straight forward argument that in order to keep better management control over the many and varied sites across the world—then appropriate management tools such as, EDC need to be considered. However, in our members’ experiences, when they are involved in the big late phase, multi-site studies, the multinational sponsors and their chosen CRO do have a technology solution in place (often this is a problem for the sites as they have to juggle multiple solutions/technologies for different sponsors/CROs/studies) – so we don’t subscribe to the argument that we are falling behind the rest of the world—we are keeping pace,” observes Mr Pennisi.
Ms Maria Chiam, Marketing Manager, Nucleus Network Limited, Australia’s leading clinical research organization for the conduct of Early Phase Clinical Trials says “Australia may be behind some parts of the world in the uptake of electronic solutions for clinical trials. I do not believe it is losing dollars to other countries in the CRO business, either due to EDC adoption or other factors. The industry has grown substantially over the recent number of years. The gap between technology innovation and successful implementation is growing again, and this may be the cause of inertia towards the adoption of EDC in Australia.”
Speaking for Novotech’s portfolio of global clinical trials, Mr Alek Safarian, CEO, Novotech (Australia), opines, “I don’t agree that Australia is falling behind the rest of the world in uptake of EDC, or that it is losing dollars to other countries. It is true that Australia does not have homegrown EDC technology of its own with worldwide acceptance, but this is true of most countries in the world. As far as actual uptake of EDC technology in commercially sponsored research, the investment is often borne by CROs or sponsors. Most commercial research done in Australia is sponsored by overseas interests. From a site perspective, the principal infrastructure requirement is having a reliable broadband internet service, and this is universally the case in Australia. To date, in our own experience, we have not encountered any resistance from sites in uptake of EDC when this has been proposed for a trial. ”
He further says, “One of the key focus areas in the Australian Government’s Clinical Trials Action Group recently set up concerns the development of a strategic plan for clinical trials in relation to information and communications technology (ICT). It remains to be seen whether the Action Group will focus on EDC specifically in tackling this area. From Novotech’s perspective, EDC uptake in Australia is not an area of concern.”
However, Mr Pennisi says, “We do see opportunities for tools that better assist with the site project management needs of sites, and to the extent that those tools can provide reliable and current management and financial information that ensure the sites are actually in control of their processes. The other area of opportunity is the ability for researchers (and probably sponsors) to be able to amalgamate the many and varied data sources that they are continuously trying to elucidate – this is an area of significant interest for us.”
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