What are the different phases of clinical trials?
Most clinical research that involves the testing of a new drug progresses in an orderly series of steps, called phases. This allows researchers to analyse data in a way that results in reliable information about the drug and protects patients. Most clinical trials are classified into one of three phases:
Phase I trials:
These are the first studies in humans after extensive studies in animals. In cancer trials the patients involved usually have cancer. In most other Phase I trials, that do not involve drugs for cancer, the patients are healthy volunteers. The number of patients in Phase I trials enrolled is small and information and data are gathered and analysed to see both how the drug affects patients and about its effect on the cancer.
Phase II trials: - Phase II trials continue to test the safety of the drug, and begin to evaluate how well the new drug works. Phase II studies usually focus on a particular type of cancer.
Phase III trials: - These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current 'standard of care' - meaning the trial compares the new drug to the therapy that is usually given to a patient who is not in the clinical trial. A participant will usually be assigned to the standard group or the new group at random. Each group or "arm", as they are often referred to, may not know to which group they have been allocated. This ensures results are not biased. Phase III trials often enrol large numbers of people and may be conducted across many doctors' offices, clinics, hospitals and cancer centres worldwide.
In addition, after a treatment has been approved by a government regulatory body (Medsafe) and is being marketed, the drug's maker may study it further in a Phase IV trial. The purpose of Phase IV trials is to evaluate the side effects, risks, and benefits of a drug over a longer period of time and in a larger number of people than in Phase III clinical trials.
To read more see http://www.melanoma.org.au/research/clinical-trial-types-phases.html
Melanoma New Zealand is keen to ensure that as many melanoma trials as possible are available for physicians to treat their patients in New Zealand.