Ph1 oncology pancreas and GI tumor study

The Issue

Ph1 oncology pancreas and GI tumor study, only site-determined responders would be reviewed centrally to confirm; at 50% subjects enrolled, no responders seen but 3 prolonged stable disease subjects identified.

RadMD asked to centrally confirm 3 stable pancreas tumor subjects, and instead identified the site had misinterpreted benign pancreatitis as tumor in 2/3 subjects.

The Resolution

Sponsor requested all subjects reviewed, RadMD identified 3 responders that sites misinterpreted as benign. Implemented independent confirmation of disease progression process whenever site identified progression for remainder of subjects.

The Results

Study would have been closed based on site reads; central review identified responders, sponsor initiated Phase 2 study based on central review.