Our experts can assist you in navigating regulatory changes and implementing the right blood pressure monitoring method or methods for your trial, including ambulatory blood pressure monitoring (ABPM), clinic blood pressure services (CBP), and home blood pressure services (HBP).
It’s long been known that high blood pressure can lead to cardiovascular events. Now, regulators are looking for a connection between increases in blood pressure and drug therapy. As a result, new FDA draft guidance advises sponsors to assess a drug’s effect on blood pressure.
Our complete Blood Pressure (BP) Services portfolio meets clinical trial needs by adding additional endpoints and addressing non-clinic-based environments. You have the flexibility to collect patients’ blood pressure in clinic or at home in a traditional, hybrid or decentralized situation.
Product detail
Ambulatory Blood Pressure (ABPM)
Regulators expect ABPM to evaluate the blood pressure effects of new drugs intended for chronic use. Our training program focuses on patient nuances and good patient coaching to improve compliance. Our site application provides immediate success or fail feedback and our portal displays quality analytics to help sites and sponsors track and mitigate patient compliance.
Clinic Blood Pressure (CBP)
Standardized automated device for blood pressure collection during clinic visit. Needed to evaluate drugs intended for short-term use. Clario specialized devices and unique application automate a “Rest Period” to calm the patient, reducing the White Coat effect, and automated replicate measurements to reduce variability and report meaningful blood pressure data.
Home Blood Pressure (HBP)
Easy-to-use home blood pressure device with integrated smartphone application extends the frequency of data collection for better safety assessment. Clario’s application walks the patient through each step to improve patient confidence and success and then sends real-time data and compliance feedback for immediate investigator review. Superior to other Home BP collection options, Clario’s solution ensures higher quality data for confident decision making.
Related solutions
Arrhythmia Analysis
Collect continuous ECG data with certainty in site-based or decentralized clinical trials with our flexible technology solutions and patient-friendly devices.
ECG — On-site to DCT and Phase I-IV
Monitor every heartbeat with precision from anywhere to assess safety and efficacy throughout your site-based or decentralized clinical trial.
Phase I/TQT Cardiac Assessment
Fulfill your ICH E14 requirement early, minimize risk and potentially reduce costs throughout your trial by collaborating with our Phase 1 Center of Excellence.
Regulatory Consultation and Statistical Analysis Expertise
Leverage our industry key opinion leaders to understand the complex regulatory landscape while minimizing risk with confidence.
FAQs
Do regulators accept clinic blood pressure data, or is ambulatory/home blood pressure data required?
When determining which blood pressure monitoring modality to implement in a trial, from a regulatory perspective all three modalities – Clinic Blood Pressure (CBP), Ambulatory Blood Pressure Monitoring (ABPM) and Home Blood Pressure (HBP) – are accepted as methodologies for determination of safety and efficacy. The different BP modalities are seen as complimentary, and many clinical trials with a defined blood pressure primary or secondary endpoint may include more than one modality. This can vary by the phase of the trial, therapeutic indication, and expected magnitude of the treatment on blood pressure.
How do we ensure consistency in BP measurements across sites?
We leverage standardized protocols (e.g., seated rest before measurement, appropriate cuff size, repeated measures, same arm each visit) and centralized training for site staff to help eliminate variability across sites. There are three foundational approaches that Clario emphasizes to ensure consistency and enhance quality data collection with our blood pressure monitoring services.
- The first is implementation of recognized scientific guidelines for the measurement of blood pressure whether for clinic, ABPM or home BP assessment.
- The second factor is based on the standardization of measurement procedures, integrating key elements into accompanying software, configured for each study uniquely and deployed to study sites.
- The third key factor is the emphasis on site training, ensuring best practices are adhered to by study site staff and participants, targeting optimal BP data acquisition while also considering the participant experience.
How do we best integrate BP monitoring into a broader clinical trial?
Blood pressure endpoints can be a component of safety monitoring or included as an efficacy measure. It is always important to take into consideration the study objectives and planned endpoints, in-clinic vs. hybrid design, phase of development, and specifics of the therapeutic indication and study population. These collectively help determine the optimal strategy and solutions to deploy in support of a clinical study protocol and the development of program objectives.
Learn more or speak with one our experts
Our team of clinical trial cardiac solution experts are always available to address questions about our cardiac solutions. Submit your contact information and we’ll be in touch shortly.