Earticle

초록

영어

The purpose of this study is to to develop a measurement indicator of how much the electonic data capture system(EDC) in clinical trials could actually enhance efficiency. To this end, we analyzed the process data used in an actual clinical research study and established a measurement indicator of time efficiency in electronic clinical trial processes (MITE-ECT). Clinical trial technology applied to improve clinical trial data collection is generally referred to as EDC. The benefits of EDC include greater data accuracy, fewer queries and shorter duration of database lock especially for the large multi-site clinical trials through direct data entry at the investigator site. The built-in edit check functions predesigned for electronic clinical trials was found to minimize the data entry errors that would result in extra data correction steps in data clean-up stage of clinical trials. Time savings could be led by lower error and query rates by reducing work that would have to be done on data cleaning.
Neverthless quantification to measure the benefits of the EDC system has not been fully developed yet.
We investigated a Phase IV multi-site clinical trial by a pharmaceutical company. During the trial in question, 8 research sites tested a total of 492 people for 10 months from February to November 2009.
To establish a time efficiency measurement indicator based upon process modeling of the case, we conducted interviews with experts, evaluated academic studies, and reviewed practical management processes. This study diagrammed the process involved in EDC and developed a measurement indicator of time efficiency. Its applicability was explored and verified for the data entry time, query resolution time and data lock time with relevant data points.
The indicator identified in this study is expected to serve as the practical measurement of efficiency of the electronic clinical data capture process. It can further be the basis for future research comparisons between paper-based and electronic schemes, clinical research comparison by phase, and learning effect analysis of the same and different phases. Application of this indicator(MITE-ECT) in conjunction with electronic clinical trial processes is expected to facilitate strategic data management by taking advantage of the flexibility and efficiency such methods can provide.

목차

Abstract
 서론
 연구방법 및 측정지표 개발
  전자적 임상시험 데이터 입력 프로세스
  전자적 임상시험 데이터 관리 시스템의효율성 측정지표 개발
  측정지표 별 4 상 의약품 임상시험 검증
 연구결과 및 토의
 결론
 Reference

저자

• Lee HyunJu [ Graduate School of Healthcare, Management and Policy, The Catholic University of Korea ]
• Inyoung Choi [ Graduate School of Healthcare, Management and Policy, The Catholic University of Korea ] Corresponding author

참고문헌