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

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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.

Target Audience

This article is informative for medical doctors working in the pharmaceutical industry; scientific researchers; physicians and health operators; and preclinical and clinical pharmacologists.

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Upon completion of this article, participants should be able to do the fdlowing:

  • Discuss practical considerations for the introduction of telemetric self-measured BP into clinical trials, and its widespread implications for the diagnosis and monitoring of the pharmacological treatment of patients in antihypertensive clinical trials.

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Authors and Affiliations

  1. Novartis Pharma AG, Postfach, Basel, CH-4056, Switzerland

    Volker Möckel PhD MSc (Clinical Trial Head), Aditya Bahl MS (Senior Insights Manager), John Varaklis BSc (Head Operations and Innovation for TM) & Albert Kandra MSc (Expert Statistician)

Authors
  1. Volker Möckel PhD MSc
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  2. Aditya Bahl MS
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  3. John Varaklis BSc
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  4. Albert Kandra MSc
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Correspondence to Volker Möckel PhD MSc.

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The Drug Information Association is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The Drug Information Association designates this educational activity for a maximum of I AMA PRA Category 1 Credit(s)™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This program is designated for a maximum of I contact hour or. I continuing education units (CEUs). 286-000-09 021-H04

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Möckel, V., Bahl, A., Varaklis, J. et al. Clinical Trials for Antihypertensive Drugs: Implications of Introducing Telemetric Self-measured Blood Pressure. Ther Innov Regul Sci 43, 233–241 (2009). https://doi.org/10.1177/009286150904300301

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  • DOI: https://doi.org/10.1177/009286150904300301

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