Sunday, December 20, 2020 11:04:30 AM
"It may may have taken them some time to identify and agree on the right comparison trials and construct these survival curves (I'm not sure sure whether they had easy access to the raw patient-level trial data from other trials)."
yes i think that raw patient-level trial data from other trials is exactly what they need to be taken seriously. Hopefully they can do something like i did with the estimation but substituting the DCVax-L blended data with the real test-arm data (and obviously more stringent handling of the historical comparison and no need to generate a markov-model):
http://jammyjames.com/analysis.php
but as you say i don't know how easy it will be for them to extract these specific details from other trials.
"As I have said in prior posts, if their original planned PFS and OS outcomes (DCVAX vs. the internal placebo group) are not significant and the only significant findings are the comparisons to historical controls, getting this accepted by NEJM or Lancet may be challenging"
yep and exactly the same likely goes for approval.
"Once the company has an acceptance letter in hand, they could in theory announce TLD in a PR saying the paper has been accepted by XX journal, and provide some additional context in the PR based on what is written in the article."
exactly what i suspect. Though I don't think they'll wait for a preprint.
yes i think that raw patient-level trial data from other trials is exactly what they need to be taken seriously. Hopefully they can do something like i did with the estimation but substituting the DCVax-L blended data with the real test-arm data (and obviously more stringent handling of the historical comparison and no need to generate a markov-model):
http://jammyjames.com/analysis.php
but as you say i don't know how easy it will be for them to extract these specific details from other trials.
"As I have said in prior posts, if their original planned PFS and OS outcomes (DCVAX vs. the internal placebo group) are not significant and the only significant findings are the comparisons to historical controls, getting this accepted by NEJM or Lancet may be challenging"
yep and exactly the same likely goes for approval.
"Once the company has an acceptance letter in hand, they could in theory announce TLD in a PR saying the paper has been accepted by XX journal, and provide some additional context in the PR based on what is written in the article."
exactly what i suspect. Though I don't think they'll wait for a preprint.
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