New Publication: Is Australia Well Equipped to Deal with Future Clinical Trials

Dr Lisa Eckstein and Professor Don Chalmers, recently published an article in the Journal of Law and Medicine that was prompted by concerns that arose after the French Biotrial (more about that here, here and here) that “left one person dead and five hospitalised.”

The article looks at the initiation and monitoring process involved in giving clinical trials the green light. Ultimately, Australian Regulation in the clinical trial space and the responsibilities as delegated between DSMBs, HRECs, and the TGA is remarkably the “light touch”.

Dr Eckstein also wrote this on DSMBs a few years prior.

L Eckstein and Chalmers, ‘Is Australia Well Equipped to Deal with Future Clinical Trials? ‘ (2016) 24  Journal of Law and Medicine 337.

First Page of the Article in the Journal of Law and Medicine at 337

 Journal of Law and Medicine Vol 24 (2016)  at 337

 

 

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