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Efficient and Effective Review of Clinical Trial Safety Data Using Interactive Graphs and Tables

Abstract

Clinical trials collect a great deal of data relating to the safety of the trial participants. The data are complex in nature and traditional approaches to data review involve using summary tables and listed data. An alternative approach to the review of clinical trial safety data is presented, allowing reviewers to access individual subject data via hyperlinked plots and tables. Examples of presentations of data for very large studies, and of the inclusion outputs from modern statistical methods are demonstrated.

Keywords

  • Random Forest
  • Patient Report
  • Graphical Presentation
  • Patient Identifier
  • Scalable Vector Graphic

These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

  • Amit O, Heiberger RM, Lane PW (2007) Graphical approaches to the analysis of safety data from clinical trials. Pharmaceut Stat 7:20–35

    CrossRef  Google Scholar 

  • Berry SM, Berry DA (2004) Accounting for multiplicities in assessing drug safety: a three-level hierarchical mixture model. Biometrics 60:418–426

    PubMed  CrossRef  Google Scholar 

  • Breiman L (2001) Random forests. Mach Learn 45:5–32

    CrossRef  Google Scholar 

  • Firth D (1993) Bias reduction of maximum likleihood estimates. Biometrika 80:27–38

    CrossRef  Google Scholar 

  • Friedman J (2001) Greedy function approximation: a gradient boosting machine. Ann Stat 29:1180–1232

    CrossRef  Google Scholar 

  • Heart Protection Study Collaborative Group (2002) MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 360:7–22

    CrossRef  Google Scholar 

  • Lin X, Parks D, Zho L, Curtis L, Stell H, Rut A, Mooser V, Cardon L, Menius A, Lee K. Truncated robust distance for clinical laboratory safety data monitoring and assessment. J Biopharm Stat (to appear)

    Google Scholar 

  • Penny KI, Jolliffe IT (2001) A comparison of multivariate outlier detection methods for clinical laboratory safety data. Statistician 50:295–308

    CrossRef  Google Scholar 

  • Ridker P, Danielson E, Fonseca FAH, Genest J, Gotto AM, Kastelein JJP, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Børge BA, Nordestgaard G, Shepherd J, Willerson JT, Glynn RJ (2008) Rosuvastatin to prevent vascular events in men and women with. New Engl J Med 359:2195–2207

    PubMed  CrossRef  CAS  Google Scholar 

  • Southworth H (2008) Detecting outliers in multivariate laboratory data. J Biopharmaceut Stat 18:1178–1183

    CrossRef  Google Scholar 

  • Southworth H, O’Connell M (2009) Data mining and statistically guided clinical review of adverse event data in clinical trials. J Biopharm Stat 19:803–817

    PubMed  CrossRef  CAS  Google Scholar 

  • Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA (2009) Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New Engl J Med 361:1045–1057

    PubMed  CrossRef  CAS  Google Scholar 

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Correspondence to Harry Southworth .

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© 2012 Springer Science+Business Media, New York

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Southworth, H. (2012). Efficient and Effective Review of Clinical Trial Safety Data Using Interactive Graphs and Tables. In: Krause, A., O'Connell, M. (eds) A Picture is Worth a Thousand Tables. Springer, Boston, MA. https://doi.org/10.1007/978-1-4614-5329-1_10

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