WHAT IS A HUMANITARIAN PROTOCOL?
Scientific testing is essential for the development of new drugs, but it can sometimes seem heartless to the layman. For instance, many clinical trials for new drags only last six to eight weeks. Thereafter, no matter how much better a participant might feel, the drug can no longer be obtained until it is fully approved and available on the market. When a patient who has been otherwise unresponsive to all other marketed compounds does extremely well on an investigational new drag, it seems cruel to withdraw the medication. Fortunately, once the testing period is over, a humanitarian protocol is available for a limited number of outpatients taking antidepressant, antianxiety and other psychiatric and medical drugs from pharmaceutical companies testing these compounds. After the initial trial, a patient may report a great improvement of symptoms along with the information that no other drag on or off the market has worked so well as the investigational drug. The patient, through the principal clinical research investigator, may then apply to the drag company with this information, and upon evaluation by the company, the patient may be given the drug to be monitored through the clinical investigator, even though it has not been approved by the FDA for release to me general public.
This is a great humanitarian boon to a limited number of patients who have been chronically (to pressed for years or suffered other illnesses dot can be relieved only by a drug still in a premarketing stage of development In these instances, the hoped-for improvement the patient found through agreeing to participate in a scientific protocol did not turn out to be temporary. The slight risk the patient took was worth it.
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Tags: Anti Depressants