Oral Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2022

Primary Focus

The legal framework surrounding the application for in receipt of compensation under the Medicines Australia guidelines, that are widely applicable to sponsored drug trials throughout Australia which there are over 15,000 per annum.

Areas of Interest

Multiple classes relevant to the conduct of clinical trials and the participant base of the patients and volunteers in drug trials and the application of compensation principles in the event that there is an unexpected adverse reaction.

Extract

Although it is very rare to have injuries from clinical trials, when it happens the participant will need assistant navigated in compensation process to have a just outcome.

The mechanism for getting compensation and how the guidelines are used, by the sponsor and the sponsor’s insurers to impose legal test of causation on the threshold for  compensation payments.

 Objectives

1. Understand the operation of the medicine Australian guidelines, the minor and major claims.
2. How those guidelines might be strengthened by regulation with the intervention of government.
3. The use of the guidelines versus the reality of negotiations with the trial sponsor and the trial sponsor’s liability insurers.