Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection

Clinical Trials

Volumn 11, Issue 2, 2014, Pages 205-217

  Lindblad, Anne S ^a   Manukyan, Zorayr ^a   Purohit Sheth, Tejashri ^b   Gensler, Gary ^a   Okwesili, Paul ^b   Meeker O'Connell, Ann ^b   Ball, Leslie ^b   Marler, John R ^b  

^a EMMES CORPORATION   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

ARTICLE; CENTRAL SITE MONITORING; CLINICAL STUDY; DRUG SURVEILLANCE PROGRAM; FOOD AND DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZATION; CLINICAL TRIAL (TOPIC); HUMAN; MEDICAL RESEARCH; STANDARDS; UNITED STATES;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84898991433     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774513508028     Document Type: Article

References (17)

1. Eisenstein EL, Lemons PW, Tardiff BE, et al. Reducing the costs of phase III cardiovascular clinical trials. Am Heart J. 2005 ; 149: 482-88 (Pubitemid 40585412)
2. Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making: Workshop Report. Washington, DC: The National Academies Press ; 1999:
3. Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008 ; 5: 75-84 (Pubitemid 351412376)
4. Buyse M. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials. Stat Med. 1999 ; 18: 3435-51 (Pubitemid 30041358)
5. Weir C, Murray G. Fraud in clinical trials; detecting and preventing it. Significance. 2011 ; 8: 164-68
6. WoodinKE. How much is enough? The high cost of source document review (SDR). CenterWatch NEWSONLINE. Available at: http://www.centerwatch.com/news- online/article/578/how-much-is-enough-the-high-cost-of-source-document-review- sdr (2006, accessed 1 March 2012).
7. Mitchel JT, Kim YJ, Choi J, et al. Evaluation of data entry errors and data changes to an electronic data capture clinical trial database. Drug Inf J. 2011 ; 45: 421-30
8. Tantsyura V, Grimes I, Mitchel J, et al. Risk-based data verification approaches: Pros and cons. Drug Inf J. 2010 ; 44: 745-56
9. International Conference on Harmonisation (ICH). ICH topic E9: Statistical principles for clinical trials. Step 5 version. International Conference on Harmonisation (ICH), Geneva, 16 September 1998. Available at: http://www.gpo.gov/fdsys/granule/FR-1998-09-16/98-24754/content-detail.html
10. Bakobaki JM, Rauchenberger M, Joffe N, et al. The potential for central monitoring techniques to replace on-site monitoring: Findings from an international multi-centre clinical trial. Clin Trials. 9: 257-64
11. J Natl Cancer Inst. 1994 ; 86: 487-89
12. O'Kelly M. Using statistical techniques to detect fraud: A test case. Pharm Stat. 2004 ; 3: 237-46 (Pubitemid 40011918)
13. Lienard JL, Quinaux E, Fabre-Guillevin E, et al. Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer. Clin Trials. 2006 ; 3: 486-92
14. Duley L, Antman K, Arena J, et al. Specific barriers to the conduct of randomized trials. Clin Trials. 2008 ; 5: 40-48 (Pubitemid 351412371)
15. Murrel P. R Graphics. London: Chapman and Hall/CRC ; 2006:
16. Wegman EJ. Hyperdimensional data analysis using parallel coordinates. J Am Stat Assoc. 1990 ; 85: 664-75
17. Guidance for industry oversight of clinical investigations - A risk-based approach to monitoring. Silver Spring, MD: Food and Drug Administration ; 2013: