Clinical pharmacology in Australia

In Australia, clinical pharmacology is a small but developing discipline useful for the generation of data concerning the efficacy and safety of new therapeutic substances. While most clinical pharmacology is carried on as an adiunct to the interests of a specialist in some branch of internal medicine, there are now, in Australia, four units titled “Clinical Pharmacology,” and more are scheduled to be established in the near future. The 1972 report of a Parliamentary Select Committee recommended that clin;cal pharmacology be better established in Australia in the interests of economy in the national drug bill and the welfare of patients. This Government interest in the discipline has resulted in Government‐sponsored training fellowships, but, as yet, there are few senior positions for clinical pharmacologists. Normal subiects and large uniform patient populations are difficult to obtain in Australia, but in specialized units it is relatively easy to arrange good clinical trials involving small patient numbers. Regulatory controls require that there is a logical progression from thorough preclinical to introductory and wider human administration in clinical trials. Regulatory gUidelines state that the protocol for a clinical trial should include written informed consent and that approval of the trial be given by the institutional review committee that functions in most, but not all, Australian teaching hospitals. The Commonwealth Health Department discourages the use of clinical trials as a guise for premarketing promotion, but actively seeks to encourage sponsors of well‐designed clinical trials in Australiq.