What happens during a typical study?
Obviously it depends on the type of study as to what is involved, but a typical “in-house” study will probably run something like this: Within 8 to 24 hours after check-in, the “study day” begins. If it is a drug trial, this is the time you will be “dosed” (given the study drug). This will usually happen in the morning of the day following check-in, and usually after you have fasted for at least eight hours, though some studies feed you breakfast just before you are dosed. The drug could be administered in any one of several ways.
The most common is to use an oral medication, either in pill form (tablet or capsule), or by drinking a liquid or powder solution. Other study drugs might be inhaled, injected, rubbed onto the skin, or absorbed from a patch applied to the skin. On many studies, a placebo (a dummy drug with no active ingredients) is given randomly to some subjects during each phase of the study. After dosing is completed, back-up subjects are sent home. The hours following dosing are likely to include most or all of the following: – Blood samples – Blood will be taken at regular intervals, most frequently in the 2-4 hours after dosing.
Blood is drawn from the arm using either a needle and syringe, or an intravenous cannula (a small plastic tube that is usually inserted into a forearm vein). The more blood samples required, the more likely you will have a cannula. – Fasting – You will usually be required to fast for between 2 to 6 hours after a dosing, so they can be sure that food is not affecting the absorption of the drug. – Position or activity restriction – Some studies may require you remain upright (sitting or standing) for 2 to 4 hours after dosing, and some require you remain in bed for this period of time. – Vital signs – Blood pressure, pulse, and temperature will be taken at regular intervals. – ECG – Many studies will involve multiple ECG recordings.