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A statistical approach to central monitoring of data quality in clinical trials

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Venet, David Doffagne, Erik Burzykowski, Tomasz Beckers, François Tellier, Yves Legrand, Catherine [UCL] Buyse, Marc

Central statistical monitoring can both optimize on-site monitoring and improve data quality and as such provides a cost-effective way of meeting regulatory requirements for clinical trials.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2012
Language Anglais
Journal information "Clinical trials (London, England)" - Vol. 9, no. 6, p. 705-713 (2012)
Peer reviewed yes
issn 1740-7745
e-issn 1740-7753
Publication status Publié
Affiliation UCL - SSH/LIDAM/ISBA - Institut de Statistique, Biostatistique et Sciences Actuarielles
Links
  1. Eisenstein Eric L, Collins Rory, Cracknell Beena S, Podesta Oscar, Reid Elizabeth D, Sandercock Peter, Shakhov Yuriy, Terrin Michael L, Sellers Mary Ann, Califf Robert M, Granger Christopher B, Diaz Rafael, Sensible approaches for reducing clinical trial costs, 10.1177/1740774507087551
  2. Baigent Colin, Harrell Frank E, Buyse Marc, Emberson Jonathan R, Altman Douglas G, Ensuring trial validity by data quality assurance and diversification of monitoring methods, 10.1177/1740774507087554
  3. Morrison Briggs W, Cochran Chrissy J, White Jennifer Giangrande, Harley Joan, Kleppinger Cynthia F, Liu An, Mitchel Jules T, Nickerson David F, Zacharias Cynthia R, Kramer Judith M, Neaton James D, Monitoring the quality of conduct of clinical trials: a survey of current practices, 10.1177/1740774511402703
  4. Grimes David A, Hubacher David, Nanda Kavita, Schulz Kenneth F, Moher David, Altman Douglas G, The Good Clinical Practice guideline: a bronze standard for clinical research, 10.1016/s0140-6736(05)66875-4
  5. Lyle K., Dent L., Bailey S., Kerridge L., Roberts I., Milne R., Carbon cost of pragmatic randomised controlled trials: retrospective analysis of sample of trials, 10.1136/bmj.b4187
  6. Buyse Marc, George Stephen L., Evans Stephen, Geller Nancy L., Ranstam Jonas, Scherrer Bruno, Lesaffre Emmanuel, Murray Gordon, Edler Lutz, Hutton Jane, Colton Theodore, Lachenbruch Peter, Verma Babu L., , The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials, 10.1002/(sici)1097-0258(19991230)18:24<3435::aid-sim365>3.0.co;2-o
  7. Evans S, Fraud and Misconduct in Biomedical Research, 186 (2001)
  8. Liénard J-L, Quinaux E, Fabre-Guillevin E, Piedbois P, Jouhaud A, Decoster G, Buyse M, on behalf of the European Associati, Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer, 10.1177/1740774506070807
  9. Brosteanu Oana, Houben Peggy, Ihrig Kristina, Ohmann Christian, Paulus Ursula, Pfistner Beate, Schwarz Gabriele, Strenge-Hesse Anke, Zettelmeyer Ulrike, Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials, 10.1177/1740774509347398
  10. 1. Introduction, 10.1016/s0022-510x(97)90039-3
  11. Hill TP, Stat Sci, 10, 354 (1996)
  12. Buyse M, Biostatistics in Clinical Trials, 432 (2001)
  13. Härdle Wolfgang, Simar Léopold, Applied Multivariate Statistical Analysis, ISBN:9783540030799, 10.1007/978-3-662-05802-2
  14. Bakobaki Julie M, Rauchenberger Mary, Joffe Nicola, McCormack Sheena, Stenning Sally, Meredith Sarah, The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial, 10.1177/1740774511427325
Bibliographic reference Venet, David ; Doffagne, Erik ; Burzykowski, Tomasz ; Beckers, François ; Tellier, Yves ; et. al. A statistical approach to central monitoring of data quality in clinical trials. In: Clinical trials (London, England), Vol. 9, no. 6, p. 705-713 (2012)
Permanent URL http://hdl.handle.net/2078.1/129563