25 May 2012 | Analysis | By BioSpectrum Bureau
AusBiotech advocates strong clinical trial program
Dr Anna Lavelle, CEO, AusBiotech, says Australia needs to improve its governance, ethics approval process and costs to encourage clinical trials
Singapore: Australia, which celebrated International Clinical Trials Day on May 20, is looking to strengthen its clinical trials industry. AusBiotech, the bioscience industry association of the country, has urged the government to complete the Clinical Trials Action Group (CTAG) change program, to strengthen Australia's position as a destination for clinical trials.
For the first time in four years, 2011 figures from the TGA indicated an increase in the number of new clinical trials in Australia. The number stood at 635 new trials, up from 574 in 2010. However, the figure was still 25 percent below the 2007 high of 865 new trials.
Clinical trials are pivotal to the biotechnology sector in Australia and is worth $450 million annually in investment, spill-over benefits and savings. "Australia is in competition with many other countries to secure trials and needs to improve its governance, ethics approval processes and costs to secure significant improvement," said Dr Anna Lavelle, CEO, AusBiotech.
"The 20 CTAG recommendations, although accepted by the government, have not been implemented in a timely manner. This is disappointing for the industry, which is waiting for change, and also the patients who have missed out on an opportunity to decrease morbidity or extend longevity. We need the governments, Federal and state, to complete the change program expeditiously," said Dr Lavelle. "The Australian skills in this area are recognized worldwide as Australia can boast quality healthcare facilities with efficient and effective clinical services, good trial support units and reliable reporting."
Dr Lavelle added that the upturn is encouraging but "should not be over-interpreted". "We still need to respond to the challenges if we are to secure needed trials for Australian patients. Often the most important aspect is under-represented and that is no trial being available for a particular condition in Australia, which precludes Australians from having the option of early access to needed therapies."
Australia's work to be internationally competitive will attract further foreign investment and a greater share of returns to the economy. Australia's global standing and reputation in clinical trials give credibility to local data for licensing purposes, as well as providing patients in need access to new and developing therapies and health care.
International Clinical Trials Day is celebrated around the world each year to celebrate the anniversary of the first known example of a clinical trial, started by Scottish naval surgeon James Lind in 1747 to investigate treatments for scurvy.
AusBiotech is active in advocating for a strong position for clinical trials in Australia and supporting the CTAG process. The CTAG responds to the Pharmaceuticals Industry Strategy Group's (PISG) recommendations to investigate priority reforms to the clinical trials operating environment to make Australia a more attractive location for investment and activity.