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Re: Dr Bala post# 596763

Monday, 05/29/2023 11:48:08 AM

Monday, May 29, 2023 11:48:08 AM

Post# of 652973
The Considerations for the Design and Conduct of Externally Controlled Trials does provide more reasons why the -L P3 is not suitable for approval, but does not change the previous states FDA concerns of OS in non-randomized settings.

Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial.

Using data from another clinical trial for an external control arm can have advantages compared to using data collected during routine clinical care, based in part on the rigor of protocol-based (and therefore more consistent) data collection. Such use would only be appropriate, however, when comparability exists between the two trial arms regarding participant eligibility criteria, treatment administration, patterns of care (e.g., location of treatment sites), recording of concomitant medications, and assessments of adverse events and outcomes. A particular concern for bias would be the selection of an external control arm from a completed trial whose outcomes are already known.

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