The Therapeutic Goods Administration (TGA) Australia has released updated guidance on running clinical trials. The handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods.
The revisions, which are the first major changes to the document since 2006, bring the information in line with the current regulatory environment and provide further details about how to set up and run studies in Australia.
Version 2.0 of the guidance covers all aspects of clinical trials, from the different phases, through to Australia-specific aspects of getting a study approved. The guidance aims to help sponsors, ethics committees, investigators and other groups understand their roles and obligations. The 2006 version of the clinical trial handbook, which has now been superseded, covered some of the same ground but in less detail and aspects of its advice had been rendered obsolete by regulatory changes in Australia.
New sections in the document include information on the advertising of experimental drugs and the retrieval and destruction of unapproved medicines. Other sections, such as a discussion of the merits of running trial extensions, are covered in more detail than previously. In expanding the document, TGA has covered topics addressed in texts on access to unapproved drugs and human research ethics it published in the early to mid-2000s.
To view the guidance on conducting clinical trials in Australia using ‘unapproved’ therapeutic goods, please click here.