👍🏻 article by @ManniMD1@TomerMeirson et al on how the marginal PFS benefit in BOSTON trial (XVd vs Vd) could well be an artifact of imbalanced censoring (let alone the delinquent control arm and inappropriate crossover)!
#mmsm
https://t.co/0ncVLy6hkD
Now Online!
CSO RCT Checklist.
@csoncol RCT team has just published in @TheLancetOncol a CHECKLIST to design and report cancer drug RCTs.
You know about CONSORT checklist for RCTs but this CSO checklist is specifically for cancer drug RCTs and incorporates items such as crossover, censoring etc that affect interpretation of cancer drug RCTs.
We have checklist at the design phase of RCTs, and hope trialists/trial funders/sponsors/reviewers/IRBs etc use this checklist to ensure the trials are designed to accurately answer questions that matter to patients.
We also have a checklist at the reporting phase of RCTs and hope authors/reviewers/editors/journals/readers and other users of the publication (regulators, payors, physicians, patients, media, public) use this checklist to ensure that the interpretations are made correctly and accurately.
Super thankful to and proud of our @csoncol Project RCT team for getting this published. Real work now begins to get this implemented.
https://t.co/aF2OW5XQVP
@oncology_bg@TomerMeirson To my mind, differential censoring is an important, under-recognised issue in clinical trials. This is a very nice demonstration of how it could affect trial results
Ever wondered why the results of 3 immunotherapy trials in urothelial cancers are different? Is it truly because the 3 drugs are different?
In this smart study led by @TomerMeirson , we show that these differences can all be explained by differential censoring alone! https://t.co/op9lrmCVpz
NATALEE phase 3 trial... deserves a sensitivity analyis !
remember the monarchE trial (adjuvant abemaciclib for 2⃣ years)
--> now we have NATALEE with adjuvant ribociclib for 3⃣ years ‼️
iDFS benefit !
... but let's have a closer look !
1/🧵
Excited to share our new study finding that the quality of subgroup analyses and claims for differential treatment effects in modern phase III oncology trials remains low, increasing risk of misinterpretation. More use of frameworks such as ICEMAN may improve future quality.
The Q of whether dietary interventions help people with cancer is very imp.
RCTs are the gold standard for evaluating interventions.
What do RCTs of dietary interventions in cancer tell us?
We eval in this systematic review of all dietary RCTs
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https://t.co/L1mMT9f8cU
One of my favorite paper with Vinay !
One goal : to make informative censoring considered as important as the control arm or post-progression therapy !
Check out the paper (open access)👇
+ More to come soon !
Read this paper carefully. Then read it again.
It will open your mind up about censoring in ways you prob have never thought about.
A true gem.
Must read for all.
https://t.co/mWEc2FfH5P
Numerous myeloma trials (belantamab!) susceptible to this!
#mmsm@VPrasadMDMPH
Big problem of IO access in control arm as trial was performed in countries lacking access. 40% of patients in control arm who got systemic therapy at relapse didn’t get IO. Censoring also an issue. The “positive” OS isn’t real. More info here…..https://t.co/gPi4pwUhCf
Redactions in clinical trial protocols are █████████████████████.
What did this partially redacted study find about redactions in clinical trials? #ChristmasBMJ
https://t.co/58cgSC5GFR
This study highlights the rise in protocol redactions and predicts that, ██████████████████████████████████████████ will be entirely redacted between 2073 and 2136 #ChristmasBMJ
https://t.co/58cgSC5GFR