best_interstIt is not uncommon for Investigators to find themselves in the position of having to decide whether following the protocol is in the best interest of the patient.  Sometimes it is clear cut but other times, it is more difficult and involves weighing up the benefits that the trial is providing versus the current health of the patient.

GCP is very clear on this point: “The rights, safety, and well-being of the trial subject are the most important consideration and should prevail over interests of science and society” (Principle 2.3).  Even if this means deviating from the Protocol to ensure their safety.  Even if it means pulling the patient off study.  Even if it means acting without talking to the Sponsor first (although this should be a last resort).

The Medical Monitor (available 24hr a day) is an excellent resource for helping making these difficult decision.  The MM may also be able to grant waivers and/or extensions to enable a patient to resume the trial at a later date should their medical condition change.  Whatever the course of action, make sure it is clearly documented and the Sponsor and HREC are informed as soon as possible.

In research, the Patient must always come first!




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