Thoughts from a Lab Rat

Many studies require a baseline as part of a study. In simple terms, a baseline is a period of time and collection of records that is compared to another set of time and records which is normally known as the pharmacology line. Okay, it’s probably not called the pharmacology line but it sounds good. The baseline is usually a period of 24 hours but can be shorter or longer. The only difference between the baseline and the pharmacology line is that the baseline is conducted without the study drug and the pharmacology line is with the study drug. All of the procedures during both periods will be done at exactly the same time. The purpose of obtaining a baseline is to compare the normal function of a study subject to the same subject taking the study drug. This allows investigators to see what changes the study drug does to your body. Normally, a baseline is done before the first dose of the study drug. That means that you may check into a study 1 to 2 days or more before the first dose. Normally, backup subjects are kept during the baseline period as subjects can still be disqualified before the first dosing. The pharmacology line period usually begins with the first dose. When doing a study that has a baseline, it is important that both periods are done exactly the same. If some time points in during one period differ from the other, then the results cannot be deemed valid. So if you do a study with a baseline, make sure you are to your procedures early.