The work showed an academic-led #ClinicalTrial was conducted sufficient well.
Huge effort was expended by many people on retrospective verification of trial data, provoked by potential regulatory use, but these efforts had no impact on primary outcome measure: PFS
2/8
This paper (“Impact of retrospective data verification to prepare the ICON6 trial for use in a marketing authorization application”) was led by @Andy_Embleton as part of his PhD work with me, Rick Kaplan & Max ParmarL
http://doi.org/10.1177/1740774519862528 🔓
3/8
Thanks for ICON6 trial in ovarian cancer for engaging openly and @ClinTrialsJ for publishing.
Given the changes these provoked, were there retrospective efforts disproportionate?
This has implications for ...
4/8
A ➡️The role of academic-led trials in supporting regulatory submissions: we need to facilitate this
5/8
B ➡️ #ClinicalTrial #Monitoring – are groups (particularly Industry) doing more than is actually needed? That has unnecessary costs, both Financial costs and Carbon costs
The latter should be of interest to the Sustainable Healthcare Coalition and other groups internationally
6/8
At Society for Clinical Trials (#SCT2023) in May-2023, there’ll be a Panel Discussion on the role of academic trials in regulatory submissions. We’ll confirm the panel shortly but includes academics, industry and regulators. Join us there?
7/8
On Day 5 we’ll return to Healthcare Systems Data and Routinely-Collected Healthcare Data.
8/8
Matt Sydes