The International Conference on Harmonization Guidelines for Good Clinical Practice (ICH GCP) is a set of international standards for the way clinical trials should be conducted. These guidelines aim to ensure consistency, and safety and well-being of human subjects involved in clinical trials. Only scientifically justified trials should be performed, and data generated must be accurate and credible. Visit ichgcp.net/ for more details.

 

Clinical trials are also governed regulatory agencies within each country. The role of health regulatory agencies is to make sure that both the risks and the benefits of a particular treatment are quantified to certain minimum standards before they can be approved as safe and effective within the limits established by a valid clinical trial program. Australia is governed by the Therapeutic Goods Administration (TGA - tga.gov.au/), New Zealand’s regulatory authority is Medsafe (medsafe.govt.nz/), European authorities are governed by the EU Directive of 2004 and the United States regulatory agency is the Food and Drug Administration (FDA - fda.gov/).

 

In Australia the TGA administers clinical trials involving drugs and medical devices. In 1987, the TGA introduced the Clinical Trials Exemption (CTX) scheme. This scheme involves a review of all clinical trials by a Human Research Ethics Committee (HREC) and the completion of an application to the TGA for the use of an unapproved medication or a medical device. The TGA evaluates the associated scientific data and approves usage guidelines for the use of these medications or devices. In 1991, the Clinical Trials Notification (CTN) scheme was introduced whereby the TGA need only be notified of the clinical trial being undertaken on the condition that a HREC, having reviewed the scientific data and proposed management of ethical issues, is satisfied that the trial provides low level risk to trial participants.