Testing medication

Testing medication is an elaborate process.
Sometimes it takes over a year to get permission to test medication in a certain hospital or groups of hospitals. That's before one test has been done!! That's for one step if the process.

The test process knows 5 steps.

Step 0

A group of 10 to15 healthy volunteers get a minimal dosage and the researcher wants to know how and where it works in the body and how long it stays in the body, how it leaves the body etc etc.

Step 1

Healthy volunteers, most of the time about a 100, get tested for how safe the medicine is at what dosages. Side effects are recorded. But because the group is small not all side effects will be found.
Again research also focusses what it does in and to the body and what chemical reactions it produces.

Step 2

For the first time the focus is on some treatment. Does the medication work?  At which dosage best? Sometimes it's used on patients. Some result must be shown, otherwise research will be stopped.

Step 3

The focus is on detailed research. Treatment effects should show in a significant way in a large group of patients. (In rare diseases this stage can take years to get enough patients)
Often the large group shows new side effects, so it should be shown the side effects can be tolerated.
If by now the results are the way they should be the medication is approved on the market.
BUT!!

Step 4

Even when a medication is approved, research goes on, with the focus on effect and safety.
As the target patients are treated, and normal treatment takes place, unknown and even serious side effects can be found. In that case approval will be withdrawn. (We've seen that for instance with Avandia).
Some medications only show negative reactions after a long time, or stop working after a while.
In this stage certain interactions with other medications show and harmfull effects in certain groups of patients might appear.

Approval of medication can be:

• for certain diseases. So when a new disease needs to be treated with that medication new testing and approval needs to take place.
• approval for testing
• preliminary approval: a much needed medicine shows positive results and isadmitted to be used if further research takes place during usage. This is high risk.. and often a preliminary approval has been withdrawn. The patients who received it have experienced negative effects.
• approval under conditions.
• approval for compassionate use... which is a kind of preliminary approval. This is sometimes the case in a crisis like this and for rare diseases. There is a hunch that a medicine will work, but full research hasn't be done or can't be done.
• Full appproval.

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