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Pathway to market: the role of Clinical Trials. Natalie Barber - Chrysalis Advisory & Peter Richmond - CAHS
Manage episode 396719112 series 3427899
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In this episode of the LSWA podcast, host Tracey Wilkinson sits down with Natalie Barber, the director of Clinical Operations at Chrysalis Advisory, and Professor Peter Richmond from the University of Western Australia.
Natalie and Peter discuss their respective roles in the clinical trial space. Peter, a paediatrician, focuses on improving children's health by conducting research on vaccines and monoclonal antibodies. He shares his involvement in every stage of the clinical trial process, from vaccine design to regulatory advisory boards.
Natalie's role is to support clinician researchers like Peter in delivering complex clinical trials. She explains the importance of understanding the protocols, engaging participating sites, and ensuring regulatory compliance.
The conversation covers the structured pathway that a drug or device must follow before being approved for the market. Natalie breaks down the phases of a clinical trial, starting from preclinical studies in the laboratory, progressing to phase 1, phase 2, and phase 3 trials involving larger populations, and even continuing with phase 4 post-marketing surveillance. She emphasises the time commitment and financial investment required, as well as the need for multicenter trials to gather data from different jurisdictions.
Throughout the episode, Natalie and Peter provide valuable insights into the world of clinical trials and the importance of evidence-based medicine. Their combined expertise offers a comprehensive understanding of the processes behind bringing new medical treatments to market.
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