Regulatory acceptance pre-mature discontinuation of study [Study Per­for­mance]

posted by dshah  – India/United Kingdom, 2022-06-23 14:52 (720 d 18:06 ago) – Posting: # 23073
Views: 1,576

Dear Vaibhav!
From your initial post, I assume the study is required to be performed in diseased condition and anticipate a steady state condition instead of single dose. Further, standardization of patient might be required and thus higher number of dose compensation for patient might be required. Thus, the dropout consideration might be high. What is really surprising, if I am understanding correct than, the assumed T/R and ISCV.
We had faced slightly different condition for NTI drug where RLD got expired during COVID period, and drop out was high due to +ve subjects. For one parameter, the acceptance criteria was not met as per FDA, and the study was rejected.
Addition of new lot of RLD will greatly increase complexity of statistics, too.
Divyen Shah

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