병인변증과 요골동맥 맥상파의 특성 파악을 위한 탐색적 관찰 연구 : 임상시험 프로토콜 개발
Development of Clinical Protocol on the Correlation Between Disease Cause Pattern Identification and Pulse Wave Variables
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초록
The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.
Abstract
The purpose of this clinical study is to develop structured clinical trial protocol and guideline for improvement of safety, useful and effective of pulse diagnosis devices. As a first step, papers on pulse diagnosis and pulse diagnosis devices from 2001 and 2013 were systematically reviewed. In the next step, we have collected the opinions from the specialists, companies, and statistician in pulse diagnosis to evaluate the current condition, the state and problem of domestic clinical trial cases of pulse diagnosis device. And we have to created protocol and case report form (CRF) in regards to site condition and characteristics of pulse diagnosis devices, and showed the guideline of eligibility criteria, operation process, investigation items, evaluation items and so on. This clinical protocol will become a basic information for a researcher in designing or performing a clinical study of pulse diagnosis devices, and be used as a useful material during acquisition of good clinical data. Furthermore, we hope to enhance the invigoration of pulse diagnosis clinical trials and the performance improvement of pulse diagnosis devices.
참고문헌 (30)
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