The intervals for my in-use study are being disrupted by holidays. I've been running a 10-week in-use study for a weekly-dose injectable product. It is labeled for refrigerated storage with instructions to bring it to room temperature before injection, so at each interval, vials will be brought to room temperature, product removed and then refrigerated again. We’ll test the material midway and at the end. The problem is that our start date of October 27th requires critical pulls on both Thanksgiving and our end-of-year shutdown.
Packaging for the stability batches started on 25-Oct which means that 27-Oct was the earliest we could start the study in order for our R&D group to include the data in their early 2023 filing. Unfortunately, labor contract rules leave us with no trained lab technicians available to pull or test samples for two of the three key test intervals, including the last interval of the study.
We had no choice but to pull the Thanksgiving sample two days early and plan to pull the New Year’s sample four days late, but this seems like a significant departure from normal use since it’s very unlikely a patient would miss a dose by more than a day.
For clarity, here is the schedule as it stands, now:
27-Oct Start: Pull 1 (Test)
03-Nov: Pull 2 (Dispense and discard)
10-Nov: Pull 3 (Dispense and discard)
17-Nov: Pull 4 (Dispense and discard)
24-Nov: Pull 5 (Test) (Moved to 22-Nov)
01-Dec: Pull 6 (Dispense and discard)
08-Dec: Pull 7 (Dispense and discard)
15-Dec: Pull 8 (Dispense and discard)
22-Dec: Pull 9 (Dispense and discard)
29-Dec: Pull 10 (Test) (Will be 02-Jan)
Will this impact the validity of the data in the filing?
Although this actually represents a worse case since it's pulling the final interval farther out, the real issue could be that this shows lack control within the stability program, meaning these "disruptions" should've been anticipated and included in the pre-approved protocol. Changing the study after the fact should involve some justification documentation included with the data. What thoughts would you like to contribute to this situation?