Clinical Trials for Antihypertensive Drugs: Implications of Introducing Telemetric Self-measured Blood Pressure

Abstract

Diagnostic devices for self blood pressure (BP) measurement at home can be coupled with telemetric data transmission to make patient's BP measurements available online for treating physicians. Once applied successfully, this new approach will have widespread implications for the diagnosis and monitoring of the pharmacological treatment of patients in antihypertensive clinical trials. Safety monitoring of BP might be optimized throughout the trial while the trial design itself could be streamlined. In case data are meant to be used for regulatory submissions, the capture and analysis of telemetric data in clinical trials should follow a stepwise approach. The usage of telemetric data such as self-measured BP in the treatment guidelines and the acceptance of the data by regulatory authorities as well as investigators is an ongoing process. Additionally, it is worthwhile to proactively discuss practical considerations for the introduction of telemetric self-measured BP into the trials. In the future, innovative telemetric tools will most likely be implemented in trials investigating different disease areas, leading to new insights for patient outcomes.