User menu

Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial

Bibliographic reference Timmermans, Catherine ; Doffagne, Erik ; Venet, David ; Desmet, Lieven ; Legrand, Catherine ; et. al. Statistical monitoring of data quality and consistency in the Stomach Cancer Adjuvant Multi-institutional Trial Group Trial. In: Gastric Cancer, Vol. 19, no. 1, p. 24-30 (2016)
Permanent URL
  1. Buyse M. Centralized statistical monitoring as a way to improve the quality of clinical trials. Appl Clin Trials. 2014. . Accessed 20 Feb 2015.
  2. 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
  3. Tudur Smith Catrin, Stocken Deborah D., Dunn Janet, Cox Trevor, Ghaneh Paula, Cunningham David, Neoptolemos John P., The Value of Source Data Verification in a Cancer Clinical Trial, 10.1371/journal.pone.0051623
  4. 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
  5. US Department of Health and Human Services, Food and Drug Administration. Guidance for industry: oversight of clinical investigations—a risk-based approach to monitoring. . Accessed 20 Feb 2015.
  6. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. EMA/INS/GCP/394194/2011. . Accessed 20 Feb 2015.
  7. 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
  8. Venet David, Doffagne Erik, Burzykowski Tomasz, Beckers François, Tellier Yves, Genevois-Marlin Eric, Becker Ursula, Bee Valerie, Wilson Veronique, Legrand Catherine, Buyse Marc, A statistical approach to central monitoring of data quality in clinical trials, 10.1177/1740774512447898
  9. Kirkwood Amy A, Cox Trevor, Hackshaw Allan, Application of methods for central statistical monitoring in clinical trials, 10.1177/1740774513494504
  10. Edwards Phil, Shakur Haleema, Barnetson Lin, Prieto David, Evans Stephen, Roberts Ian, Central and statistical data monitoring in the Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage (CRASH-2) trial, 10.1177/1740774513514145
  11. Lindblad Anne S, Manukyan Zorayr, Purohit-Sheth Tejashri, Gensler Gary, Okwesili Paul, Meeker-O’Connell Ann, Ball Leslie, Marler John R, Central site monitoring: Results from a test of accuracy in identifying trials and sites failing Food and Drug Administration inspection, 10.1177/1740774513508028
  12. Pogue Janice M, Devereaux PJ, Thorlund Kristian, Yusuf Salim, Central statistical monitoring: Detecting fraud in clinical trials, 10.1177/1740774512469312
  13. 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>;2-o
  14. Evans S. Statistical aspects of the detection of fraud. In: Lock S, Wells F, Farthing M, editors. Fraud and misconduct in medical research. 3rd ed. London: BMJ Publishing Group; 2001. p. 186–204.
  15. Buyse M, Evans S. Fraud in clinical trials. In: Armitage P, Colton T, editors. Encyclopaedia of biostatistics. New York: Wiley; 2005. p. 2023–31.
  16. Al-Marzouki S., Are these data real? Statistical methods for the detection of data fabrication in clinical trials, 10.1136/bmj.331.7511.267
  17. George Stephen L, Buyse Marc, Data fraud in clinical trials, 10.4155/cli.14.116
  18. Tsuburaya Akira, Yoshida Kazuhiro, Kobayashi Michiya, Yoshino Shigefumi, Takahashi Masazumi, Takiguchi Nobuhiro, Tanabe Kazuaki, Takahashi Naoto, Imamura Hiroshi, Tatsumoto Naokuni, Hara Akinori, Nishikawa Kazuhiro, Fukushima Ryoji, Nozaki Isao, Kojima Hiroshi, Miyashita Yumi, Oba Koji, Buyse Marc, Morita Satoshi, Sakamoto Junichi, Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): a phase 3 factorial randomised controlled trial, 10.1016/s1470-2045(14)70025-7