Phase I clinical trials for the FDA... Here is some documentation describing the objectives of P1 studies:
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Phase I trials look at how safe a treatment is and try to determine the best dose. A phase I trial tries to find out:
- how the new treatment should be given (such as by mouth or injection) and how often
- the safest dosage and the highest dose a person can tolerate (maximum tolerated dose)
- Participants are divided into groups called cohorts.
- Each cohort is made up of 2–6 people.
- The first cohort is given a dose that is thought to be safe (based on the results of animal studies). Then the dose is gradually increased in the other cohorts. This increase in dose is called dose escalation.
- what effect the drug or therapy has on the body
- what side effects people taking the drug or treatment experience
A phase I trial is often the first time a new drug, combination of drugs or therapy is tested on humans, so these trials may involve more risk compared to phase II or III trials. For this reason, phase I trials usually involve only a small number of people with cancer (about 15–30) who are not getting better with standard treatment. Phase I trials are not always specific to one type of cancer and may be used in people with different types of cancer.
Phase I trials may also test an already approved drug or therapy to try to improve its effectiveness or see if it can be used in a different way. For example, a phase I trial may test a drug or therapy that is already used for another disease or type of cancer.
Most phase I studies in children are done once phase I of the adult trial has been completed or is near completion. They use the same drug or treatment as the adult trial. However, children are often started on a lower dose than that given to adults.
The dose and schedule that researchers find most effective with tolerable and reversible side effects in a phase I trial is used to determine the dose and schedule of a phase II trial.
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