AusBiotech marks Clinical Trials Day with call for action

Clinical trials are pivotal to the biotechnology sector in Australia and thought to be worth $450 million annually in investment, spill-over benefits and savings.

Dr Anna Lavelle, CEO of AusBiotech said: “Australia is in competition with many other countries to secure trials and needs to improve its governance, ethics approval processes and costs to secure a significant improvement.

“The 20 CTAG [Clinical Trials Action Group] recommendations, although accepted by government, have not been implemented in a timely manner. This is disappointing, for not only the industry waiting on change, but patients who may 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.”

“The Australian skills in this area are recognised worldwide as Australia can boast quality healthcare facilities with efficient and effective clinical services, good trial support units and reliable reporting,” she said.

For the first time in four years, the recent 2011 figures from the TGA indicate an increase in the number of new clinical trials in Australia: 635 new trials were recorded, up from 574 in 2010, but still down on the 2007 high by 25% (865).

Dr Lavelle said: “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.

Australian biotechnology evolves from the high-quality, basic medical research, and a strong translational capability is required to support progress through the early stages of development.

International Clinical Trials Day is celebrated around the world each year on this day 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.

Aboard a ship on the open sea, Lind compared six treatments, including citrus fruit, on 12 sailors with scurvy, and found this treatment to be the most effective – reporting his experiment in 1753 in 'A treatise of the scurvy'. This information proved important for Australia, as Captain Cook used this knowledge to keep his sailors scurvy free on their voyages of discovery.

Clinical trials are now a vital step in developing new treatments and hope to patients globally, as new medicines, diagnostics and medical devices are developed.

AusBiotech is active in advocating for a strong position for clinical trials in Australia and supporting the CTAG process. 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.

Australia needs a vibrant, productive, efficient, internationally-competitive and world-class clinical trials industry to support local biotech development within Australia.