Ambulatory Blood Pressure Monitoring as a Vital Component of Clinical Trials.

The white coat hypertension effect is one that needs to be carefully controlled for in clinical testing and clinical trials. Ambulatory blood pressure monitoring is an effective means of overcoming this. Patients’ and volunteers’ tendency to increased blood pressure in a clinical setting or in the presence of clinical staff can affect the results of a trial, swaying statistical data away from reliable numbers.

With the expense of clinical trials and the cost of developing pharmaceuticals such an effect can not afford to be overlooked. A number of different methods are used throughout the medical profession to work around this problem. One of the most common is to measure the patient’s or volunteer’s blood pressure (BP) at regular intervals over a twenty four hour period. This allows the patient to acclimatise to the clinical environment and clinical staff to offset the BP raising effect of being in such an environment.

Measuring the effects of BP medication or other medication that may affect blood pressure in the unusual environment of a clinical setting may not give useful results even if the effects of white coat hypertension are accounted for.

In order to monitor BP under the normal circumstances of day to day life the patient can be fitted with a continuous BP monitoring device. This will carry out ambulatory blood pressure monitoring as they go about their daily routine, taking part in activities that will have varying effects on blood pressure.

This method has the additional benefit of delivering a 24 hour BP profile. This can show the subject’s variation of blood pressure at particular times of day. Being able to carry out continuous ambulatory blood pressure monitoring in this way means that BP can be measured against a number of factors such as the time of day the medication was ingested, the delay in its effects upon reaching the system, natural variations with changes in the circadian rhythm and monitoring the drop or lack thereof in blood pressure during sleep.

Java CR in collaboration with our colleagues at Dabl can offer an innovative platform which sets a new standard for the timely collection, processing and analyses of higher quality ABPM/blood pressure data for use in the clinical trial setting.