Phases clinical trials FDA

A new treatment goes through several phases. Each phase has a different purpose:

  • Phase I trials test if a new treatment is safe and look for the best way to give the treatment. Doctors also look for signs that cancer responds to the new treatment.
  • Phase II trials test if one type of cancer responds to the new treatment.
  • Phase III trials test if a new treatment is better than a standard treatment.
  • Phase IV trials find more information about long-term benefits and side effects.

Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.

Phase I Trials

Test if a new treatment is safe in people. Doctors also find the best way to give the treatment.

The goal of a Phase I trial is to:

  • Find out if a new treatment is safe.
  • Find the best way to give the new treatment, such as by mouth or by vein.
  • See if there are signs that cancer responds to the new treatment.

Phase I trials usually include 15 to 30 patients who are divided into small groups. These groups are called cohorts. The first cohort receives a dose of the new drug. Doctors may collect blood or urine samples to measure drug levels in the patients.

If the first cohort does not have any severe side effects, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the doctors find the best dose for future testing. With each increasing dose, doctors test each patient to see if he or she is responding to the treatment. If the doctors find that the treatment is safe, then it will move forward to be studied in a Phase II trial.

Phase II Trials

Test if a new treatment works in one type of cancer.

Fewer than 100 patients usually join a Phase II trial. Even though the main goal is to see if the treatment works, doctors still closely watch patients’ side effects. If the new treatment works, doctors may go on to study it in a Phase III trial.

Phase III Trials

Test if a new treatment is better than standard treatment.

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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