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These clinical trial plans involve the hypothesis of compassionate use of drugs. The execution of a Compassionate Use Program (CUP) consists of making a medicine available, for compassionate reasons, to patients suffering from a chronic or severely debilitating disease or from a disease considered to be potentially fatal and who cannot be satisfactorily treated with an authorized medicine .

It is a way to make a promising but not yet authorized drug available to patients who:

📌 Currently cannot be satisfactorily treated with authorized drugs;

📌 Have a disease for which there is still no authorized drug;

📌 It cannot be included in an ongoing clinical trial.

Are there any other ways to obtain medicines before they are authorized?

Doctors can also obtain a promising drug for a patient by requesting a supply of a drug from the manufacturer, to be used on a patient under their immediate responsibility. This is called “personal prescription” treatment and should not be confused with compassionate use programs.

In this case, the doctor responsible for the treatment contacts the manufacturer directly. While manufacturers record what they provide, there is no central record of patients who receive treatment in this way.