Blood pressure monitoring is an essential aspect of many clinical trials. Most obviously, this applies when a new hypertension drug is being developed, in which case an increase or decrease in blood pressure may be the trial’s primary endpoint.
Beyond that, though, a large number of drugs have a potential cardiac impact. Since elevated blood pressure is a known risk factor for strokes, heart attacks and even death, any spikes in blood pressure should be factored into the drug’s risk-benefit assessment.
As Declan Arthur, head of marketing at dabl Clinical Trials, explains, there are various categories of drug that may fall into this bracket.
“These include antidepressants, anti-HIV therapy, drugs for treating addiction and drugs for treating malignancy,” he says. “Blood pressure needs to be monitored any time a drug is going to affect your heart.”
Other examples might include drugs activating the sympathetic nervous system; hypoglycemic agents; immunosuppressive agents; NSAIDS and analgesics; sex hormones, steroids and stimulants. In each of these cases (particularly in early safety studies) frequent blood pressure measurements should be taken.
A new consortium
dabl Clinical Trials, an Irish company specialising in blood pressure data collection and management for clinical trials, has worked in this field since 2000. The company provides protocol development advice, expertise and data analysis.
“Our online systems are configured to the protocol of each study, which enables faster trial site set-up and close out, significantly reducing trial costs,” says Arthur. “The system offers automatic and instant validation of data, which helps greatly with patient retention. It typically achieves the capture of 100% evaluable data, saving on time and cost and ultimately delivering better trial outcomes.”
Recently, dabl announced it would take part in an exciting new collaboration. Together with its partners in the consortium, it will work to develop intelligent wearable sensors for health applications.
“dabl will contribute its considerable knowledge in both software and hardware development,” says Arthur. “It will be responsible for developing the software in relation to a range of biomarkers, including blood pressure. The other members of the consortium have been assigned responsibilities in accordance with their specific areas of expertise.”
The Tyndall National Institute, which is spearheading the project, is a leading European research centre in integrated information technology. Some areas of expertise include smart sensors and systems, nanomaterials processing and circuit design.
The gold standard for blood pressure measurement
Currently, the gold standard in blood pressure management is ambulatory blood pressure monitoring (ABPM). In contrast to the one or two measurements used in doctors’ offices, this technique provides automatic profiles of a person’s blood pressure over a 24-hour period.
“Here you wear a cuff on your arm and a small monitoring device on your waist that triggers every 20/30 minutes, depending on trial protocol, so it squeezes on your arm and takes your blood pressure,” says Arthur. “When you go to the doctor, you tend to be slightly stressed so you may have what is called a ‘white coat response’. ABPM negates that effect and gives you a much better profile of the patient’s blood pressure.”
Since blood pressure can fluctuate throughout the day, including a full day’s worth of readings gives a more balanced picture. On top of that, ABPM generates a huge volume of data and therefore reduces the number of patients required.
Then there is the fact that it can detect potentially dangerous dips in nocturnal blood pressure.
“During our sleep patterns our blood pressure may fail to dip, but this is not detected in a doctor’s office scenario,” says Arthur. “If someone takes a drug at 10pm, their blood pressure may drop during the night, so we can’t just use a one-off reading.”
Last May, the FDA released draft guidance on blood pressure response, with important implications for drug developers. It recommends ABPM for high precision measurements, particularly in trials where blood pressure is measured over 24 hours.
dabl’s ABPM software provides an automatic, interpretative report of each patient’s data, making the process more accessible to patients and doctors.
Aims of the project
The new smart wearables project, called HOLISTICS, is currently in its very earliest stages and is slated to last three years.
“It’s impossible for us to say at this point what the product is going to look like, but the objective would be to measure a range of biomarkers other than blood pressure,” says Arthur. “We envisage the product has to be wearable and comfortable for a patient. It will focus on using smart sensors, and will pick up blood pressure measurements in a different way.”
Although the specifics remain to be seen, the consortium will deliver end-to-end solutions based on emerging new technologies. These will include human-centric intelligent sensors, which can wirelessly communicate medically validated data.
The project has been awarded €7.5m in funding, as part of the first tranche of the €500m Disruptive Technologies Innovation Fund. This ten-year fund, established by the Irish Government, is intended to stimulate private investment in new technologies (especially artificial intelligence) and aims to develop Ireland’s ecosystem of innovation.
“Ireland has long been the European hub for some of the tech industry’s most forward-thinking firms,” says Arthur. “As a member of this consortium, dabl will very much be playing its part to keep Ireland at the forefront of innovation in tandem with the aims of the Irish government.”
Over the next three years, the team hope to develop a best in class device for the clinical trials market, monitoring not just blood pressure but also other vital signs. With the digital health industry growing quickly, there should be a healthy appetite for technologies of this kind.
“dabl has been at the forefront of research and development in blood pressure management and data analysis for almost 20 years,” says Arthur. “Our intention is to leverage this boom by continuing to innovate to ensure we offer the most advanced technology solutions for clinical trials globally.”