Saturday, August 19, 2006

Clinical Trials: Phase 1, 2 , 3 and 4 ---(1)


These are the earliest trials in the life of a new drug or treatment. They are usually small trials, recruiting anything up to 30 patients (often a lot less).

When laboratory testing shows a new treatment might help treat a certain disease, phase 1 trials are done to find out:

* The safe dose range
* The side effects
* How the body copes with the drug
* If the treatment shrinks cancer

The first patient to take part will be given a very small dose of the drug. If all goes well, the next person will get a slightly higher dose. With each patient taking part, the dose will gradually be increased and the effect that has will be monitored. Any side effects will be recorded.

In a phase 1 trial, you may have lots of blood tests, as the researchers look at how the drug is affecting you. And at how your body copes with, and gets rid of the drug.

People entering phase 1 trials often have severe disease and have usually had all the treatment available to them. This is because they may benefit from the new treatment in the trial, but many won't. The aim of the trial is to look at doses and side effects. This work has to be done first, before we can test the potential new treatment to see if it works. Phase 1 trials are important because they are the first step in finding new treatments for the future.

Source: Cancer Research UK

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