Clinical-trial bridging
For a patient rolled off an investigational product whose commercial equivalent is now FDA-approved — we coordinate the bridge, under the treating physician's direction, within strict guardrails.
A particular situation that arises in rare disease and oncology is a patient who has been on an investigational product in a US-run clinical trial and, for reasons of eligibility, trial close-out, or protocol exit, is no longer supplied with the investigational product under the study. When the product has since been approved by the FDA and the treating physician wants the patient on the commercial equivalent, the operational question is how to bridge.
What the coordination looks like
The treating physician — who is usually also the site investigator or a closely connected clinician — writes a named-patient letter that establishes the clinical rationale for continuing on the commercial equivalent of the product the patient had been receiving on-study. That letter goes to our dispensing partner. The order is reviewed against the same DSCSA and state-pharmacy standards that apply to any named-patient coordination. The commercial therapy is delivered to the institution or, where the patient is no longer under institutional care, to the patient under the treating physician's direction.
What we do not do
We do not extend the trial, we do not supply investigational product, and we do not act as a compassionate-use contact for sponsors. Trial-bridging is strictly the coordination of a commercial, FDA-approved therapy for a patient who has established eligibility through their prior trial exposure and whose treating physician now wants to continue on the approved therapy.
Documentation we ask for
- Prior-therapy timeline including the investigational-product exposure (even at the granularity of "Trial X, Arm Y, from DATE to DATE").
- Treating physician's signed order for the commercial equivalent, with dose and cycle schedule.
- Any sponsor or IRB acknowledgement of trial exit that is already on record, where relevant.