Trial status. The trial is actively enrolling patients.
Category: Glossary
Randomization
When patients are randomly split into groups. When you choose to participate in a trial where participants are given different drug combinations, you will be randomly assigned to receive one or the other. This helps to prevent bias and ensures that results are accurate.
When trial participants are given an inactive substance that resembles a trial drug, like a sugar pill. Placebos are sometimes tested against real drugs to make sure that the real drug is effective. However, placebos are not commonly used in cancer clinical trials, because intentionally giving patients an ineffective treatment would put them at risk. Instead, experimental treatments are compared with standard-of-care. If there is not a standard-of-care option, trials compare against “best supportive care” which is appropriate palliative care without any other anticancer therapies. You will be told if there is a placebo, standard-of-care or best supportive care involved in a trial you are looking into.
Principal investigator (PI)
The lead researcher in charge of a particular clinical trial.
A statistical measure that defines whether a result is statistically significant. It refers to the likelihood of achieving the same result as the trial by pure chance. If the p-value is below 0.05, there is a less than 5% chance that the results happened by chance. This gives us confidence that the results were due to the trial drug or treatment.
Overall response rate (ORR)
Percentage of patients whose tumors shrink or disappear.
Open-label
A type of trial in which both patients and doctors know which arm of the trial a patient is on.
Non-inferiority
A trial that compares a new treatment to a standard of care treatment that is currently used. The aim is to prove that the new treatment is not worse than the treatment currently approved.
Neoadjuvant
Chemotherapy before surgery.
A patient is considered treatment-naive if they have never undergone a specific treatment before. For example, a patient who has never had FOLFOX would be considered Oxaliplatin-naive.