Online Program

Impacts of ABPM Quality Criteria on Primary Endpoint: The Comparison of Two ABPM Parameter Derivation Methods and ABPM Missing Data Imputation (302330)

Janell Chen, US Food and Drug Administration 
*Dalong Patrick Huang, FDA/CDER  

Keywords: Pressor Effects, Blood Pressure, Abulatory Blood Pressure Monitory, ABPM, Mean Value Calcualtion, Missing Data

In May 2018, the Food and Drug Administration (FDA) released a new draft guidance — “Assessment of Pressor Effects of Drugs Guidance for Industry”. The purpose of the guidance is to advise sponsors on the premarketing assessment of a drug’s effect on blood pressure. As elevated blood pressure is known to increase the risk of stroke, heart attack, and death, the effect of a drug on blood pressure can be an important consideration in cardiovascular safety profiling and benefit-risk assessment.

Ambulatory blood pressure monitoring (ABPM) study is recommended in the guidance for the premarketing assessment of a drug’s presser effect. To facilitate the successful implementation of this guidance, we investigated the impacts of different ABPM quality criteria on the primary analysis and two commonly used methods in the derivation of ABPM parameters. ABPM data features and missingness were investigated as well.