On Biostatistics and Clinical Trials
CQ's web blog on the issues in biostatistics and clinical trials.
Showing posts with label
Submission
.
Show all posts
Showing posts with label
Submission
.
Show all posts
Friday, November 11, 2022
Rolling Review, Real time oncology review (RTOR), and Split real time application review (STAR) Program
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For New Drug Application (NDA) and Biological License Application (BLA), the usual process is to submit the entire package with different mo...
Wednesday, November 24, 2021
Are data listings for clinical study reports still needed in the era of CDISC standard data sets (SDTM)?
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Traditionally, all data fields that are collected in clinical trials, will be listed in so-called 'data listings'. The data listings...
Sunday, May 23, 2021
Are we moving away from data listings now that the standard data sets (such as CDISC-compliant SDTM and ADaM data sets) are mandated by FDA?
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After a clinical trial is concluded, the statistical group (statisticians and statistical programmers) will generate the tables, listings, a...
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