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Compassionate Use Protocol

GS Paper II Health

Context:

Recently, in a hospital in Hyderabad, a patient in the ICU with an extensive drug resistant bacterial infection, was treated under a ‘compassionate use protocol’ with a drug cefepime-zidebactam which is undergoing phase 3 trials.

What is a Compassionate use protocol ?

It is a potential pathway for a patient with a serious life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Expanded access may be appropriate when all the following apply:

Patient has a serious or immediately life-threatening disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a clinical trial is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.

News Source: The Hindu

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