Risk Sharing Arrangement

An arrangement agreed between the supplier of a PBS-listed medicine and the Australian Government that adequately monitors identified risks (or undesired events such as cost-ineffective use or greater-than-expected use) and manages them by appropriate mechanisms for...


The probability of an event is the risk of it occurring. Another meaning of risk is the chance that a test or treatment will cause injury or harm. Risks are a product of the effect of a hazard and the level of exposure.  HTAI


A social enterprise to to speed up access to better treatments by making sure people are empowered with a knowledge of clinical trials and how to get involved, and are not alone in their journey to learn about, take part in, and partner with researchers to make trials...

Real world evidence

The clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real world data. Real world evidence can be generated by different study designs or analyses, including but not limited to, randomized trials,...

Real World Data

The data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources. RWD can come from a number of sources, for example: electronic health records, claims and billing activities, product and disease registries,...


A measure of how often a specific event happens in a given amount of time. For example, during the trial the side effect rate was 0.4 (4 in every 10 patients experienced a side effect)  HTAI

Randomised controlled trial

A study in which the people taking part are assigned by chance (randomisation) into groups (such as the control group or the study group). The groups are managed in exactly the same way except they are given different treatments, or exposed to a risk factor of...

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