Cel Sci Corporation (CVM)

[Biobonic]

How many misdiagnoses does one think occurred in the Phase 3 enrollment process?

From the Phase 2 trial Journal of Clinical Oncology

Of the 21 LI-treated patients, 19 were assessable. Two of the treated patients were enrolled and subsequently confirmed as having anaplastic carcinoma of the uvula and adenocarcinoma of the floor of the mouth, respectively. These two patients were administered the full course of therapy, including the administration of the investigational drug, but they were not part of the histopathology and immunohistochemistry analysis because they did not meet the criteria for having OSCC.

These two misdiagnoses were excluded from the analysis...

From the Sri Lanka progress reports...

Losses/exclusions after randomization:

Exclusions sounds active, like there is a procedure for CROs to exclude those who are misdiagnosed, and it was determined after randomization, surgery, biopsy, etc...

The CRO would still enroll additional patients to take the place of these mis-diagnosed.

From NCBI

Summary points
Trial investigators can exclude patients' data from analysis, without risking bias, when ineligible patients are mistakenly randomised into a trial