Consideration of Factors that Effect Blood Pressure Monitoring is Critical in the Success of Clinical Trials

Clinical settings can have undesirable effects on blood pressure data. Participants in trials often become anxious or stressed in clinical surroundings or even merely in the presence of doctors and other medical staff. This is known as “ white coat hypertension “  If these factors that raise blood pressure artificially are not taken into account the gathered data can be at best unreliable. An effective means of assessing  for the effect is through blood pressure monitoring.

There are a variety of different techniques that can be employed to overcome the consequences of white coat hypertension and rule it out from the results of product trials.

One of the most straightforward methods used to do this is to take the participants BP measurements over the course of a twenty four hour period at regular intervals. This means that the participant has time to get used to the clinical setting and allow their BP to return to normal levels. It also has the benefit of recording variations due to the participant’s natural circadian rhythms.

24 hour blood pressure monitoring can also be carried out outside of the clinical setting. Often it is not necessary or even useful to have the patient sitting in a clinic for the duration of the trial. The clinic does not provide the kind of regular environment that the participant would operate in, doing activities that can raise or lower their BP in way that cannot be accounted for in the clinic.

By fitting the participant with a continuous monitoring device a steady stream of data can be gathered throughout the day as the participant goes through their daily routine and as they encounter unusual circumstances in the world. For instance, being caught in a traffic jam on the way to work or an unexpected emergency at work could contribute to erratic blood pressure levels that are a normal part of the end consumer’s life. The blood pressure monitoring device can account for these instances in a way that similar monitoring in a clinic cannot.