Journal of Internet Computing and Services (인터넷정보학회논문지)

Korean Society for Internet Information (한국인터넷정보학회)
권호 표지
DOI QR코드

DOI QR Code

A Performance Evaluation Framework for e-Clinical Data Management

임상시험 전자자료 관리를 위한 평가 프레임웍

  • 이현주 (가톨릭대학 의료경영대학원)
  • Received : 2011.10.19
  • Accepted : 2012.01.06
  • Published : 2012.02.29
Download PDF
⟨ Previous Next ⟩

Abstract

Electronic data management is getting important to reduce overall cost and run-time of clinical data management with the enhancement of data quality. It also critically needs to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop the performance evaluation framework in electronic clinical data management. Four key metrics in the area of infrastructure, intellectual preparation, study implementation and study completion covering major aspects of clinical trial processes are proposed. The performance measures evaluate the extent of regulation compliance, data quality, cost and efficiency of electronic data management process. They also provide measurement indicators for each evaluation items. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management - clinical site, monitoring and data coordinating center. As of the initial attempt how to evaluate the extent of electronic data management in clinical trials by Delphi survey, further empirical studies are planned and recommended.

임상시험 전체 소요시간 및 비용의 절감, 임상 데이터 질의 향상을 위해 임상시험 전자자료의 관리가 점차 중요해지고 있다. 또한 임상시험 전자자료 관리는 전자 임상시험의 안정성 및 질을 위해 규정 가이드라인을 준수하는 것이 결정적으로 필요하다. 본 연구는 전자적 시스템을 활용한 임상시험에 있어 데이터 관리의 성과를 평가하기 위한 프레임웍을 개발하고자 한다. 연구의 목적을 위해 임상시험 프로세스에 근거하여 기반능력, 연구설계, 연구진행 및 연구완료 등 네 개의 주요 메트릭을 구성함으로써 데이터 관리의 수준을 측정할 수 있는 성과척도를 도출한다. 이때 각 성과척도의 도출 기준은 임상시험 자체가 지향하는 데이터의 질 향상, 전자자료 관리 프로세스의 비용과 효율성 및 규정 준수 수준 등 네 가지의 관리적 관심을 기준으로 하며, 각 성과척도 별로 전자자료 관리 프로세스 상 실질적으로 측정 가능한 측정지표를 제시한다. 평가 프레임웍은 네 가지의 주요 측정 메트릭에 근거하여, 세 개의 데이터 영역(연구기관, 모니터링, 데이터관리센터) 별로 구성된다. 본 평가 프레임웍의 개발은 전문가 의견 수렴을 통한 델파이 방법론으로 접근한 탐색적 연구로서 향후 실증적 후속 연구를 과제로 남기고 있다.

Keywords

References

  1. Marks R, "Validating e-Source Data in Clinical Trials," Controlled Clinical Trials, Vol.25, pp. 437-446, 2004. https://doi.org/10.1016/j.cct.2004.07.001
  2. Welker J, "Implementation of EDC Systems: Barriers and Solution," Contemporary Clinical Trials, Vol.29, pp.329-336, 2007.
  3. Arab L, Hahn H, Henryo J, Chacko E, Winter A and Cambou M, "Using the Web for Recruitment, Screen, Tracking, Data Management, and Quality Control in Dietary Assessment Clinical Validation Trial," Contemporary Clinical Trials, Vol.31, pp.138-146, 2010. https://doi.org/10.1016/j.cct.2009.11.005
  4. Lu Z, "Technical Challenges in Designing Post- Marketing eCRFs to Address Clinical Safety and Pharma- covigilance Needs," Contemporary Clinical Trials, Vol.31, pp.108-118, 2010. https://doi.org/10.1016/j.cct.2009.11.004
  5. Broeck J, Cunningham S, Eeckels R, Herbst K, "Data Cleaning: Detecting, Diagnosing and Editing Data Abnormality", PLoS Medicine [Online]. Vol.2, No.10. pp.966-970, 2005. Available: www.plosmedicine.org
  6. Knatterud G, Ricjgikdm F, Gerigem S , Barton F, Davusm C, Faiweather W, Honohan W, Mowery R and O'Neill R, "Guidelines for Quality Assurance in Multicenter Trials: A Position Paper," Controlled Clinical Trials, Vol.19, pp.477-493, 1993.
  7. Moher D, Jada A, Nichol G, Penman M, Tugwell P and Walsh S, "Assessing the Quality of Randomized Controlled Trials: An Annotated Bibliography of Scales and Checklists," Controlled Clinical Trials, Vol.16, pp.62-73, 1995. https://doi.org/10.1016/0197-2456(94)00031-W
  8. Nahm M, PieperC, CunninghamM. "Quantifying Data Quality for Clinical Trials Using Electronic Data:, PLoSMedicine[Online].3(8). pp.1-8. www. plosmedicine.org, 2008
  9. Lee H and Choi I, "Effect Analysis of Electronic Clinical Trial Systems Using Measurement Indicator of Efficiency," Journal of Korea Contents Association, Vol.11, No.1, 2011.
  10. Pavlovic I, Kern T and Miklavcic D, "Comparison of Paper-based and eData Collection Process in Clinical Trials: Costs Simulation Study," Contemporary Clinical Trials, Vol.30, pp.300-316, 2009. https://doi.org/10.1016/j.cct.2009.03.008
  11. Ene-Idordache,B, Carminati S, Antiga L, Rubis,N, Ruggenti P, Remuzzi G and Remuzzi A, "Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with Demand Trial," Journal of America Information Association, Vol.16, pp.404-408, 2009. https://doi.org/10.1197/jamia.M2787
  12. Prodeedings of 14th Annual Workshop in DIA Japan for Clinical Data Management; New Genesis of CDM to Drive Worldwide Clinical Studies. Jan. 2011
  13. Prokscha S, Practical Guide to Clinical Data Management, Taylor and Francis, 2007.
  14. Guide for Industry; Computerized Systems Used in Clinical Investigations (CSUCI), FDA, 2005. April.
  15. Guidance for Industry, E6 Good Clinical Practice,
  16. Korean Good Clinical Practice, KFDA, 2009.
  17. Stanley R, Lillis K, Zuspan S, Lichenstein R, Ruddy R, Gerardi M and Dean J, "Development and Implementation of a Performance Measure Tool in an Academic Pediatric Research Network," Contemporary Clinical Trial.,Vol.31, pp.429-437, 2010. https://doi.org/10.1016/j.cct.2010.05.007
  18. Okoli C and Pawlowski S, "The Delphi Method as a Research Tool: Example, Design Considerations and App," Inf& Management, Vol.42, pp.15-42, 2004.2004, https://doi.org/10.1016/j.im.2003.11.002
  19. Schmidt R, "Managing Delphi Surveys Using Non-parametric Statistical Techniques," Decision Sciences, Vol.28, No.3, pp.763-774, 1997.
  20. Edmondson A, Bohmer R and Pisano G, "Disrupted Routines: Team Learning and New Technology Implementation in Hospitals," Administrative Science Quarterly, Vol.46, No.4, pp.685-716. 2001. https://doi.org/10.2307/3094828
  21. Marray J & Hammon J. "Delphi: A Versatile Methodology for Conducting Qualitative Research," The Review of Higher Education, Vol.18(4), pp.423-436, 1995. https://doi.org/10.1353/rhe.1995.0008

Cited by

  1. Topology-aware Packet Size and Forward Rate for Energy Efficiency and Reliability in Dynamic Wireless Body Area Networks vol.15, pp.2, 2014, https://doi.org/10.7472/jksii.2014.15.2.09
  2. Status Report on Usage of Electronic Case Report Form for Clinical Study vol.12, pp.12, 2012, https://doi.org/10.5392/JKCA.2012.12.12.714