NDLI: Increasing patient safety in drug trials with computer based analysis

Content Provider	IEEE Xplore Digital Library
Author	Zywietz, T.K. Khawaja, A. Petrovic, R. Fischer, R. Reinstaedtler, J.
Copyright Year	2009
Description	Author affiliation: Dept of Biometrics, MHH, Hannover, Germany (Fischer, R.) \|\| Cardinal Health Research Services, Wuerzburg, Germany (Reinstaedtler, J.) \|\| Biosigna - Istitute for biosignal-processing and system-analysis, Munich, Germany (Zywietz, T.K.; Khawaja, A.; Petrovic, R.)
Abstract	Today, the pharmaceutical industry relies on ECG recordings (digital Holter or 12 lead resting ECG) to ensure cardiac safety of subjects in drug trials. State of the art is a central ECG analysis in ECG core labs, where the ECGs are analyzed fully manual by specially trained technicians or experienced cardiologists. The ECGs are commonly analyzed within 48 hours after upload to the core lab, independent on whether the ECG is critical or not. In order to reduce the response time in case of critical ECGs, we have developed a 12 lead resting ECG analysis algorithm to quantitatively classify the ECGs (according to typical criteria applied by pharmaceutical sponsors). As bottom line statement, the ECGs are classified into “normal” (N), and “abnormal” (AN). The basic idea was to identify any abnormality and then prioritize the ECGs for over-read in the core lab. The algorithm was tested and validated against a data base of 12.980 ECGs of 1.223 patients, recorded in a drug trial and analyzed in a professional core lab. The following paper describes our methodology, and the results obtained with the above described data base. We also provide an outlook on how our new algorithm will be applied in future drug safety trials.
Starting Page	245
Ending Page	248
File Size	607884
Page Count	4
File Format	PDF
ISBN	9781424472819
ISSN	02766547
e-ISBN	9781424472826
Language	English
Publisher	Institute of Electrical and Electronics Engineers, Inc. (IEEE)
Publisher Date	2009-09-13
Publisher Place	USA
Access Restriction	Subscribed
Rights Holder	Computers in Cardiology(CinC)
Subject Keyword	Safety Drugs Electrocardiography Pharmaceuticals Algorithm design and analysis Digital recording Manuals Cardiology Delay Testing
Content Type	Text
Resource Type	Article

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