Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs

Contemporary Clinical Trials

Volumn 31, Issue 1, 2010, Pages 108-118

  Lu, Zhengwu ^a  

^a NONE   (United States)

Author keywords

CDASH; Electronic case report form; Electronic data capture; MedDRA; Pharmacovigilance; Post marketing study; UADE

Indexed keywords

DECISION MAKING; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FINANCIAL MANAGEMENT; HEALTH PRACTITIONER; INFORMATION PROCESSING; MEDICAL LITERATURE; PRACTICE GUIDELINE; REVIEW;

DATA COLLECTION; DATABASE MANAGEMENT SYSTEMS; DRUG TOXICITY; HUMANS; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; PRODUCT SURVEILLANCE, POSTMARKETING; SOFTWARE; WORKFLOW;

EID: 73249133512     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2009.11.004     Document Type: Review

References (19)

1. EI Emam K., Jonker E., Sampson M., Krleža-Jerić K., and Neisa A. The use of electronic data capture tools in clinical trials: web-survey of 259 Canadian trials. J Med Internet Res 11 1 (2009) e8
2. Miller E, Deleger S, Murphy J. Implementing and Managing Adaptive Designs for Clinical Trials. Accessed at http://www.pharmaceutical-int.com/categories/interactive-clinical-techno logies-inc/implementing-and-managing-adaptive-designs-for-clinical-trial s.asp. Accessed at November 17, 2009.
3. Lu Z.W. Information technology in pharmacovigilance: benefits, challenges, and future directions from industry perspectives. Drug Healthc Patient Saf 1 (2009) 35-45
4. Strom B.L. Potential for conflict of interest in the evaluation of suspected adverse drug reactions - a counterpoint. JAMA 292 21 (2004) 2643-2646
5. Kubick W.R. Observational data under the microscope. Appl Clin Trials 18 4 (2009) 34-38
6. Hyveled L., Karpur P., and Nakskov H. Knowledge innovation and clinical operational excellence. Drug Inf J 43 2 (2009) 159-170
7. CDISC CDASH core and domain teams. Clinical Data Acquisition Standards Harmonization (CDASH) (October 2008)
8. Hammond W.E. The power of working together. Annual meeting of DIA data conference, Philadelphia, Pennsylvania, USA (March 9-11, 2009)
9. Buetow K. Building a 21st Century Biomedical System: the cancer Biomedical Informatics Grid (caBIG®). Annual meeting of DIA data conference, Philadelphia, Pennsylvania, USA (March 9-11, 2009)
10. Central Coding (2009). http://www.phaseforward.com/products/clinical/edc/coding/ accessed at http://www.phaseforward.com/products/clinical/edc/coding/. Accessed May 25, 2009
11. Ludwick D.A., and Doucette J. Adopting electronic medical records in primary care: lessons learned from health information systems implementation experience in seven countries. Int J Med Inform 78 1 (2009) 22-31
12. Research and Markets. Electronic Data Capture and Management: Assessing Opportunities to Streamline the Clinical Trial Process, accessed at http://www.researchandmarkets.com/reports/219049. Accessed May 25, 2009.
13. Brandt C.A., Argraves S., Money R., Ananth G., Trocky N.M., and Nadkarni P.M. Informatics tools to improve clinical research study implementation. Contemp. Clin. Trials 27 2 (2006) 112-122
14. Trontell A. Expecting the unexpected - drug safety, pharmacovigilance, and the prepared mind. NEJM 351 14 (2004) 1385-1387
15. US Food Drug Administration. CFR - Code of Federal Regulations Title 21: Chapter 1-Department of Health and Human Services, Subchapter D - Drugs for human use. PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION, April 2009. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?f r=312.32. Accessed October 22, 2009.
16. Rosenberg M, Bowden M. Beyond Data Capture: the Promise and Limitations of Technology. Accessed at http://www.healthdec.com/media/articles/BeyondDataCaptureThePromiseandLi mitationsofTechnology.pdf. Accessed May 25, 2009.
17. Hyperhar Group. Moving from EDC to a complete eclinical trial solution, accessed at http://www.ngpharma.com/article/Issue-8/Information-Technology/Moving-fr om-EDC-to-a-complete-eclinical-trial-solution/. Accessed June 10, 2009.
18. Richesson R.L., and Krischer J. Data standards in clinical research: gaps, overlaps, challenges and future directions. J Am Med Inform Assoc 14 6 (2007) 687-696
19. Anabase International Corp. A View to the Future, accessed at http://www.ngpharma.com/article/Issue-15/Clinical-Research/A-View-to-the -Future. Accessed June11, 2009.