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Big Risks From Quick Drug Trials (Australia)

This article was originally published in PharmAsia News

Executive Summary

Australian clinical drug trials must be approved by an ethics committee, which was formed in 1991 in an attempt to speed up the drug research and development process. Before that, all trials had to be approved by the Therapeutic Goods Administration. The committee has dramatically cut approval time from three years to three months. The quick approval process allowed over 3,000 clinical sites to be registered for trials last year. The Australian drug industry invests about $520 million a year on research and development. Approximately 90 percent of that money goes to clinical trials. In addition, many large U.S.-based pharmaceutical companies have also been attracted to the Australian R&D market. But critics worry the system may be too lax. Although there have been no major problems in Australia, health and safety regulations have been under increased scrutiny around the globe. Last year six healthy volunteers in England died during a drug trial, highlighting the risks of a clinical trial system that is largely self-regulating. (Click here for more



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