Standardized and centralized blood pressure monitoring in clinical trials has expanded from a preliminary focus in cardiovascular, specifically hypertension drug development, as an efficacy endpoint to an increasingly important safety endpoint across all therapeutic indications. The development of the draft FDA pressor effect guidance evolved out of industry and regulatory discussions with the goal of enhancing patient safety.
One of the primary goals of this session is to provide insight and clarification associated with the draft guidance. Although a well-recognized diagnostic endpoint in clinical care and drug development, blood pressure assessment continues to be an important topic of discussion in drug development. This presentation will focus on the implementation of BP monitoring in clinical trials with specific attention to the considerations to monitoring blood pressure as a safety “Off-target” endpoint. Previous discussions surrounding the topic re-surfaced in early 2000 and have continued to be an important industry consideration as noted in recent industry and scientific presentation and publications. Included in the webinar will be a review of the BP monitoring options that have been implemented in clinical trials including: Ambulatory Blood Pressure Monitoring (ABPM), Automated Office Blood Pressure Monitoring (AOBPM) and remote telemonitored home blood pressure (BP).
Register for this session to hear a review of trial design considerations and technology/BP methodology selection using a case study approach. Questions related to performing an intensive BP study in a healthy volunteer versus evaluating the potential BP response/signal in the intended patient population in defining the blood pressure response will also be reviewed during this presentation.
Jeff Heilbraun, VP, Medical and Scientific Affairs, Cardiac Safety Service, Bioclinica
Jeffrey Heilbraun attended Tufts University in Boston, Massachusetts where he completed his Bachelor of Science degree in Biology with a focus on physiology. Jeff continued his studies at the American University in Washington D.C., receiving a fellowship and completing his Master of Science in Health Promotion and Disease Management. He was employed at the American University as an adjunct professor in the Health Promotion program.
Throughout his career, Jeff has maintained his focus on the science, technology, trial design and regulatory considerations surrounding cardiac safety (ECG and blood pressure endpoints) within pharmaceutical development, with a special interest in hemodynamics. Jeff has presented posters and session participation at the Drug Information Association (DIA) meeting, American Society of Hypertension (ASH), and at the Cardiac Safety Research Consortium (CSRC). He has supported publications in cardiac safety considerations in oncology drug development and the regulatory considerations for “off-target” blood pressure response in compound development.Message Presenter
Who Should Attend?
- Medical and scientific affairs
- Project management
- Clinical operations, Clinical Development, Clinical Research
- Regulatory affairs – cardiac safety
- Research site study coordination
- Clinical monitoring
- Medical Monitors
- Clinical Scientists
- Imaging Scientists
- Protocol Managers
- Clinical Data Managers
What You Will Learn
Participants of this webinar will learn to:
- Identify the approach to defining an off-target increase in blood pressure for a developing compound
- Differentiate between the devices available for assessing BP in clinical trials
- Identify design and analysis considerations for a study to define the potential BP signal
- Provide case study experience in implementing BP monitoring in clinical trials across different trial phases
Bioclinica is a global, life-science provider that utilizes science and technology to reduce risk of clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.