Data informs debate.

Abstract

The editorial ‘Data informs debate’ (Aust Prescr 2015;38:38-9) describes the uncertainties around the efficacy and safety of new medicines entering the market. It outlines the role that increased access to clinical trial data may have in informing assessments about the appropriate place of new drugs in clinical practice. Just as it is important to consider new drugs, it is also important to consider the use of currently available drugs in new markets, or new populations. Populations vary, for a variety of reasons, in their response to specific drug therapies.1,2 Australia has a unique population in its Aboriginal and Torres Strait Islander people. This population may not have been included in clinical trials, so further analysis of trial data will often not be informative. Substantial uncertainty exists regarding the safety and efficacy of medicines in Aboriginal and Torres Strait Islander people, despite their need for extensive use of medicines to manage the high burden of disease. It is important that Australian prescribers are aware of the limitations of drug safety and efficacy data for Aboriginal and Torres Strait Islander people. Clinicians are encouraged to publish their own observations, including reporting adverse drug reactions, to the Therapeutic Goods Administration. These observations are essential to inform robust assessment of medicines for Australia’s indigenous populations.3-6