Cancer Trials: An Important Option for Patients

The goal in this phase is to see how safe the research treatment is and how well it works compared to a standard approved treatment. The number of participants will depend on how common or rare the type of disease or condition being studied is.

In a Phase 3 cancer study, participants will be assigned to either a group that receives a standard treatment or a group that gets a research treatment. Participants are randomly assigned, which means they won’t know which group they will be placed in, but they have an equal chance to receive either treatment.

The outcomes of the two groups are compared to see which group benefitted more. If the group that received the research treatment benefits more than the one that received the existing approved treatment, the research data is typically used to file for FDA approval. This is done so that the research treatment can be approved for doctors to start prescribing the treatment.

Why Phase 3 Is So Important

Out of all the trial phases, Phase 3 cancer clinical trials usually include the largest number of participants. This allows the participants to be diverse and reflective of the people who are most commonly diagnosed with the type of cancer being treated in the trial. The results of a Phase 3 trial are pivotal as they provide comprehensive safety and efficacy information.