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Clinical Trial Phases

Phase I Clinical Trials

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In General

A Phase I cinical trial is the most experimental phase of clinical trials. Previously, the drug has not been testsed in humans.

Purpose

The primary purpose of a Phase I trial is to evaluate the safety of a new drug or treatment. A Phase I trial seeks to determine:

  • An initial dosage range.
  • The best method of administration (oral, injection).
  • Possible side effects.

There are generally no conclusions about how well a drug works in Phase I trials.

Number Of Participants

In Phase I trials, researchers generally administer the new treatment to a small group of people, usually 10-80 participants.

What Happens

For drug studies, the researchers generally begin by providing a very lose dose. The dosage level is slowly increased as new patients enter the trial.

Monitoring For Side Effects

Patients are carefully monitored for harmful side effects. Although the treatments have been well tested in the lab prior to the trial, there may still be significant risk.

Because the treatment being studied is new, researchers don't always know the expected side effects. Side effects or adverse reactions may include headache, nausea, hair loss, and skin irritation, among others. In some rare cases the side effects may be serious or even life threatening.

Many side effects are only temporary and go away when the treatment is completed or stopped. Other side effects can be permanent. For this reason, some phase I trials may be limited to patients whose condition cannot be helped by other known or proven treatments.

Duration

Phase I trials generally last for several months.

Conclusion

If the drug or treatment appears to be safe, it moves to Phase II. Approximately 70% of drugs or treatments tested in Phase I trials proceed to the next phase.

 


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