The impact on investigator involvement post HREC/IRB notification of the clinical oversight committee recommendation is yet to be disclosed.
Presuming OncoSil are aware of and compliant with ethics reporting requirements. I am doubtful.
This is really going to hurt site and participant recruitment efforts. Almost certai that participants will withdraw on becoming aware of proven lack of clinical benefit.
No related updates on clinicaltrials.gov or ANZCT databases as yet. Watch this space.
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