Mea Culpa25 Oct 2021 14:16
I am not surprised or worried that MRx0518 / Keytruda slips into Q1 2022, in fact, I am surprised that the study has been able to keep going through Covid. I am sure a number of you are fully aware of what is required of a candidate who agrees to participate in a trial, others may not be. In the case of the MRx0518 phase1 trial with Imperial College it required a pre-examination visit lasting approx 4 hrs, then dosing and a further 6 follow up hospital visits for check ups Blood, Urine and Poo samples. Post surgery your are required to attend another 4 check up sessions over the next two years.
I personally pulled out after the initial preexam session as everything took too long - you are treated as any other patient in the NHS and join the same queues for bloods, ECG etc; prior to this trial I had agreed to give additional biopsy samples for testing, (the prelims for this) got me kicked off a scheduled biopsy slot, spending an additional afternoon in hospital.
7 visits to a hospital during Covid did not strike me as a great idea given I was being classed as "extremely vulnerable" by the NHS. Drug companies outsource the trials to a third party testing company who in turn effectively outsource it to the NHS - so it is pretty difficult for the likes of 4D to completely control the schedule.
My trial commencement was Feb 2020 and at that point I was not invested in 4D Pharma, had I been invested at that time I still would have dropped out given the covid risk.