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Effect Analysis of Electronic Clinical Trial Systems

효율성 측정지표를 활용한 전자적 임상시험프로세스 효과분석

  • 이현주 (가톨릭대학교 의료경영대학원) ;
  • 최인영 (가톨릭대학교 의료경영대학원)
  • Received : 2010.08.09
  • Accepted : 2001.12.22
  • Published : 2011.01.28

Abstract

The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

Acknowledgement

Supported by : 한국학술진흥재단

References

  1. 신상구, "한국의 임상시험 트렌드 현황", 국가임상시험단, KRPIA R&D Committee Inauguration Symporium, 2009.
  2. 신아미, 박희준, 정선주, 노미진, 김윤년, "종이의 무기록과 전자의무기록의 기재정도 및 일치도 비교연구: 심방세동 환자 입원기록을 중심으로", 대한의료정보학회지, 제15권, 제2호, pp.201-208, 2009.
  3. 이영철, "국내 임상시험 데이터 관리 현황과 전망", 보건정보통계학회 추계학술대회, 2008.
  4. 정순옥, 권수경, 최인영, "임상시험시스템 현황분석과 적용방안 모색", 임상약리학회지, 제16권, 제1호, pp.37-44, 2008.
  5. T.Bart, "Comparison of Electronic Data Capture with Paper Data Collection- Is There Really an Advantage?", Business Brief Pharmatech, pp.1-4, 2003.
  6. R. Edwards, S. Edwards, J. Bryner, K. Cunningham, A. Rogers, and M. Slattery, "A Computer- assisted Data Collection System for Use in a Multicenter Study of American Indians and Alaska Natives," Computer Methods Programs Biomed, Vol.90, No.1, pp.38-50, 2008. https://doi.org/10.1016/j.cmpb.2007.11.019
  7. K. Emam, E. Jonker, K. Krleza-Jeric. and A. Neisa, "The Use of Electronic Data Capture Tools in Clinical Trials: Web-Survey of 259 Canadian Trials," Journal of Medical Internet Research, Vol.11, No.1, 2009.
  8. P. Kabol, "Assessing the Accuracy of Computerized Medication Histories," American Journal of Medical Care, Vol.10, No.11, pp.872-877, 2004.
  9. J. Litchfield, J. Freeman, H. Schou, M. Elsley, R. Fuller, and B. Chubb, "Is the Future for Clinical Trials Internet-based," A Cluster Randomized Clinical Trial," Clinical Trials, Vol.2, pp.72-79, 2005. https://doi.org/10.1191/1740774505cn069oa
  10. H. Lee and I, Choi, "Developing a Measurement Indicator of Time-Efficiency in Electronic Clinical Trial Processes," International Conference on Internet, 2010.
  11. E. Lopez-Carrero,C.,Arriaza., E. Bolanos., A.Ciudad., M.Municio, J.Ramos. and W.Hesen, "Internet in Clinical Research Based on a Pilot Experience," Contemporary Clinical Trials, Vol.26, pp.234-243, 2005. https://doi.org/10.1016/j.cct.2004.11.017
  12. C. Park, C. Lee, and C. Kim, "Effect of Electronic Medical Record on Quality Improvement of Psychiatric Inpatient Medical Record," Korean Journal of Psychopathol, Vol.10, No.2, pp.118-125, 2001.
  13. Pavlovic, T. Kern, and D. Miklanvcic, "Comparison of Paper-based and Electronic Data Collection Process in Clinical Trials: Cost Simulation Study," Contemporary Clinical Trials, Vol.30, pp.300-316, 2009. https://doi.org/10.1016/j.cct.2009.03.008
  14. S. Prokscha, Practical Guide to Clinical Data Management, Taylor & Francis, 2009.
  15. C. Spink, "Electronic Data Capture as a Means for e-Clinical Trial Success," IBM Global Services, Pharmaceutical Clinical Development, 2002(3).
  16. S. Thwin, K. Clough-Gorr., M. McCarty, T. Lash., S. Alford,, D. Buist, S. Enger, T. Field, F. Frost, F. Wei, and R. Siliman, "Automated Inter-rater Reliability Assessment and Electronic Data Collection in a Multi-Center Breast Cancer Study," BMC Medical Research Methodology, Vol.18, 2007.
  17. M. Wahi, D. Parks, R. Skate. and S. Golding, "Reducing Errors from the Electronic Transcription of Data Collected on Paper Forms: A Research Data Case Study," Journal of American Medical Informatics Association, Vol.15, pp.386-389, 2008. https://doi.org/10.1197/jamia.M2381
  18. J. Welker, "Implementation of Electronic Data Capture Systems: Barriers and Solutions," Contemporary Clinical Trials, Vol.28, pp.329-336, 2007. https://doi.org/10.1016/j.cct.2007.01.001
  19. "Conspiring Forces Behind EDC Adoption," A Special CenterWatch Article, Vol.10, No.2, 2003, http:// www. centerwatch.com

Cited by

  1. Current State and Applications of the Electronic Clinical Trial Process in Korea vol.13, pp.4, 2013, https://doi.org/10.5392/JKCA.2013.13.04.281