As clinical trial oversight has moved online as technology is more utilised in clinical trials, it brings up some questions about whether documents are as well considered as before.
Clinical trial oversight is the structured system of governance, monitoring, and regulatory evaluation used to protect patient safety, ensure scientific integrity, and maintain compliance with Good Clinical Practice (GCP) standards.
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A principal investigator (PI) holds the ultimate local-site responsibility for the conduct, scientific integrity, safety, and regulatory compliance of a clinical trial. As a result, it is important that documents are well considered.
On top of this, the PI is the only avenue for patient-reported problems to reach the sponsor. It is therefore important that oversight is not only accurate, but also meaningful so that sponsors can better understand any potential safety or tolerability concerns that could lead to protocol amendments.
In this episode, editor Abigail Beaney speaks with Tracy Vanderslice, VP of Clinical Operations at Gilead Sciences, who also works with TransCelerate, a non-profit industry consortium which aims to simplify, streamline, and accelerate the clinical research and drug development process, about the current issues and what can be done to rectify these, while not overburdening sites which are already struggling with demand.
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