Clinical trials are designed in phases with safety in mind Clinical trials are designed in phases, and a trial treatment can only move on to the next phase if the trial shows no safety concerns and that it may work.
Phase 1 studies Study if the treatment is safe and potentially helpful. These typically include a small number of people with advanced disease whose treatments have not worked. Phase 2 studies Study how well the medicine works and how safe it is in a small number of people with a specific disease.
Phase 3 studies Usually study the new treatment compared to the standard treatment in a larger number of people.
At this point, a sponsor (who funds the research) may submit the results to a health authority, such as the FDA, to have the trial treatment approved for people to use if the trial treatment is safe and works well.
Phase 4 studies Study the long-term safety and benefit
of an FDA-approved treatment in a large number of people.
What makes clinical trials safe for patients? Clinical trials follow strict guidelines and laws to keep people safe. All clinical research studies in the US must be reviewed and approved before they begin by: l Health authorities, such as the FDA l An Institutional Review Board (IRB), a team of independent experts and members whose job is to make sure participants’ rights are fully protected and that they are not exposed to any unnecessary risks
Before you enroll in a trial, a doctor or nurse will clearly explain the study procedures and requirements. This is called informed consent. Doctors are not allowed to enroll patients in clinical trials until they make sure the patient understands what their involvement in the trial means for them.
Melanoma Patient and Caregiver Guide | Stages 2–3 24
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