Reading Clinical Studies by Nathan Cherny
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 Published On Mar 16, 2023

Reading Clinical Studies: Taking off the rose colored glasses, and the peril if we don’t

Nathan I Cherny MBBS, FRACP, FRCP
Prof Nathan Cherny presents an approach to the systematic critical evaluation of clinical studies to identify some of the common issues that bias the outcomes of clinical research in oncology.
The talk will highlight issues related to:
1. surrogate endpoints and their predictive reliability for true clinical benefit
2. study design and implementation issues that may exaggerate overall survival
3. issues related post hoc and subgroup analyses and the important distinction between confirmatory and conjectural findings

Background Paper: https://www.ncbi.nlm.nih.gov/pmc/arti...

Comments from chat:
What do you think of yesterday's announcement by Jeremy Hunt - that the UK/MHRA will speed up the approval of drugs. Based on the presentation, how concerning is this?
Another related problem -the UK government has identified 'nutriceuticals' as a growth area. There is no area with lower evidence standards than the supplement industry
In the US pricing has historically not been a significant issue (in Oncology)
Amazing insights, thank you so much for sharing! The HTA as the balancing actor to account for the lack of evidence is a good way to regulate this.
Or the situation where a drug has been approved, but not submitted to all HTA bodies, as results of the trials lead to too much uncertainty of results?
There will be pricing negotiations for Medicare in the next few years
The problem is that some pharma will simply not submit to certain countries - as outcome is predicted to be negative. This has started to happen with BMS drugs
every ineffective treatment that's sold adds to GDP -perhaps that's why politicians don't care enough

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