Objective |
Phase I trials are the first step in testing a new approach in humans. |
Phase II study mainly focuses on patients afflicted with a particular type of cancer. |
During phase III trials researchers compare the new agent or treatment to the current gold standard treatment. |
Phase IV trials usually take place after the treatment has been approved for standard use. |
Main Purpose |
The main purpose of this phase is to:
- Evaluate what is the safest dosage with less side effects.
- Analyze the best route of administration (by mouth, intramuscular, or intravenous etc.).
- Study the frequency in which the drug should be administered.
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The main purpose of this phase is to:
- Analyze whether the new agent or intervention works for that specific cancer.
- Study the safety and effectiveness of the new agent or treatment.
- Evaluate how it affects the human body.
- Show that the new agent or intervention is as safe as the standard treatment.
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The main purpose of this phase is to:
- Test the ultimate safety, efficacy, and dosage of the new agent or treatment for a specific disease that has worked well in previous phases.
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The main purpose of this phase is to:
- Further evaluate the long-term safety and effectiveness of a treatment.
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Features |
Features of study:
- Phase I trials usually enroll a small number of patients; around 10-30 patients.
- Phase I trials last several months to a year.
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Features of the study:
- Phase II trials usually enroll fewer than 100 patients.
- On average, it takes several months to 2 years to be completed.
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Features of the study:
- Phase III trials may include hundreds to thousands of people across the country including patients of different ages, ethnicities, and gender.
- Phase III trials last between 1-4 years to be completed.
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Features of the study:
- Several hundred to several thousand people may take part in a phase IV study.
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Strategy |
Strategy of the study:
- Patients are divided into smaller groups, called cohorts.
- Each cohort is treated with an increased dose of the new therapy or technique.
- The highest dose with an acceptable level of side effects will be determined appropriate for further testing.
Approximately 70% of drugs move to the next phase. |
Strategy of the study:
- Phase II trials are often double-blinded, meaning that neither the researcher nor the patient knows which is the control group receiving a placebo and which is the group receiving the treatment.
- If results show that the new agent or treatment is as effective and safe as the standard treatment, research then can move to the next phase.
Approximately 33% of drugs move to the next phase. |
Strategy of the study:
- Researchers collect data from large numbers of patients, which then are randomly assigned to the standard treatment group or the new treatment group.
- Once the research demonstrates that the new agent or treatment works well against a specific disease, researchers can apply for the approval of the Food and Drug Administration (FDA).
- If data from the clinical trial meets the FDA standards and regulations, the FDA approves the treatment for a specific use.
Approximately 25-30% of drugs move to the next phase.
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Strategy of the study:
- Phase IV trials take place after the treatment has been approved for standard use.
These studies are less common than phase I, II, or III trials. |
