| As the globalisation of outsourcing services in drug development continues at pace, Alek Safarian of Novotech offers his perspective on conducting clinical trials in Australia
The clinical trial scene in Australia has undergone a major transformation in the last 15 years. Australia has always enjoyed an excellent record in biomedical and public health research. However, it is an environment for industry-sponsored clinical research as a commercialisation route for new products that has really blossomed in recent years. Much of this is self-evident given the number of international and local contract research organisations (CROs) active in Australia. This article gives some general background for considering Australia as a venue for clinical development plans.
REGULATORY ENVIRONMENT
The regulatory environment is one of the key strengths of the Australian market for clinical trials. With some early planning, a typical study can get started within a two to three month timeframe. This compares favourably with many parts of the world. Importantly, there is no local investigational new drug (IND) equivalent submission to make. There are two schemes open to sponsors for approval to conduct a clinical trial. The vast majority opt for the more streamlined clinical trials notification (CTN) scheme. Under this scheme, the principal regulatory barrier to starting a study is review by a properly constituted ethics committee (EC). Once an EC has reviewed and approved the study, the sponsor notifies the Therapeutic Goods Administration (TGA) and the trial can start.
By contrast, the clinical trials exemption (CTX) scheme requires a formal regulatory review by TGA in addition to the EC review, and can more than double the time needed before a study can start. It is fair to say that most sponsors do not opt for the CTX scheme for clearance to conduct a clinical study. However, for particularly complex protocols, or where detailed regulatory scientific review of existing data is warranted (a first in man study, for example), ECs may be unwilling to approve a protocol until it has gone through the rigours of the CTX scheme. In that case, a formal submission and review by the TGA will be required before the site EC will approve the protocol. The vast majority of all clinical trials conducted in Australia are via the CTN scheme. |
