Supply/Dose administration Best Practices

Trial projections indicate that too much supply is being utilized in the current dose administration methods used.  Need an expert to advice on supply best practices such that product is being utilized more efficiently.  Thinking a clinical affairs/trial design/clinical supply expert or perhaps even a clinician or nurse specialist could solve this issue for us.

Phase 1 program, indication- oncology.  Currently utilizing an IV infusion w/syringe pump and, at higher doses, IV bag.  However it looks as though a Lot is not going to be enough to treat as many patients as anticipated, if this issue isn’t solved.

Current instructions call for line priming that seems to waste half the dose w. line loss.  Seems the people who designed the administration procedure are not familiar with clinical dosing practices or clinical trial supply issues.

The ideal solution prevents supply from being lost, and is a core set of supply and dosing procedures that can be used by diverse hospital settings.

Objectives and success criteria:

    • reduced waste in dose administration
    • if prep instructions are well written, dose would be better
    • supply workflow
    • Pharmacy instruction, pharmacy manual
    • determine resupply triggers
    • Help with supply projections
    • ad hoc troubleshooting

Other background info re: trial:   Single trial, 30-40 sites planned: initial dose escalation is 10 sites, planning to expand to 20-30 sites in 4-5 expansion cohorts, 30 patients each.  IRT is all set up.  IND filed late last year.   Dosing is based on body weight, dosed every 3 weeks. 

Looking to start in the next month or so, need a high degree of confidence that expert can add value. 

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