More information on clinical trial protocols and eligibility.
Within the protocol, there is usually a section describing the background information about the condition to be studied, and about the treatment to be tested. This provides information about the previous results with the new treatment in laboratory or human studies. The number of patients to be enrolled in the study is listed, and often there is a prediction of how long the study is expected to take and an indication of where the study will be performed. There is always an important section which indicates clearly what the eligibility criteria are for the study.
The eligibility criteria are essentially what determines which patients can enter into the study. Usually these criteria are written to ensure that the patients entered in the study are in reasonably good health, so that the risk of severe side effects or problems related to the study treatment is minimized. The criteria are also designed to make sure that the type of cancer situation that is being tested is well-defined, so that after the study, correct conclusions can be drawn about who the treatment might benefit. Usually the criteria exclude patients who are pregnant or lactating, due to unknown risks to a fetus. Sometimes the criteria require that a patient lives within a certain distance of the treatment centre, to ensure they are safely treated in the event of any severe or unexpected side effects from treatment.
The protocol describes in detail what is being measured or compared, and how the measurements and comparisons are to be performed. This is again to ensure that correct conclusions can be drawn after the study is completed. The protocol also tells pharmacists and nurses exactly how to give the treatments. There is a schedule for tests which must be performed for patients on study, to measure treatment effects and to assess safety and side effects of treatment. There are strict rules for reporting of side effects, particularly serious or life-threatening side effects, so that information can be shared as quickly as possible with other people doing the study.