Phase I trial – Is the drug/treatment safe?
A Phase I trial is the first time a treatment has been tested outside of the research laboratory in a patient and lasts days to weeks.
- These treatments are still experimental in nature but have shown positive results in the early research stage.
- Phase I trials can offer hope and opportunity for our patients with advanced or rare cancers, or where traditional lines of treatment are no longer effective. They can also empower patients to contribute to the future of cancer treatment.
Phase II trial – Does the drug/treatment work?
This phase aims to gather data on if the drug or treatment is effective on those who have the certain disease or condition that is being treated.
- These trials can last for months to years.
- Phase II trials also continue to study the safety of the treatment, including short-term side effects
Phase III trial – Is the drug/treatment better than what is already available?
These trials gather more information about safety and effectiveness through studying different populations and different dosages, or using the experimental treatment in combination with other standard therapies.
- The experimental drug/treatment is administered to a large group of people to confirm its effectiveness compared with standard of care or equivalent treatments
- These trials can last months to years
- If the Department of Health agrees that the Phase III trial results are positive, it may approve the experimental drug or treatment for use in the general public
Phase IV trial – What else do we need to know?
After a drug/treatment has been approved and made available to the public, researchers track its safety to seek more information about their risks, benefits and optimal use through a Phase IV clinical trial.
- Researchers monitor the treatment’s safety through identifying any rare or long-term side effects and evaluating the real-world effectiveness in long-term situations