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Editorial
. 2008 Sep 25;359(13):1400-2.
doi: 10.1056/NEJMe0807372. Epub 2008 Sep 3.

Identifying and addressing safety signals in clinical trials

Thomas R Fleming
Editorial

Identifying and addressing safety signals in clinical trials

Thomas R Fleming. N Engl J Med. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Hazard Ratios for the Composite Safety End Pont of Death from Cardiovascular Causes, Myocardial Infarction, or Stroke in the Celecoxib Group, as Compared with the Naproxen Group, According to Possible Outcomes in an Ongoing Trial
The graph shows four possible outcomes in the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen) trial, which is being conducted to assess whether investigators could rule out an unacceptable increase in safety risks associated with celecoxib, as compared with naproxen. The black circles represent the point estimates, and the horizontal lines the 95% confidence intervals, for the risk of the composite safety end point with celecoxib, as compared with naproxen. In essence, if the entire confidence interval for the hazard ratio lies to the left of 1.33, the trial is “positive” in that investigators can rule out the possibility that the risk of the composite safety end point is 33% greater in the celecoxib group than in the naproxen group. If the entire confidence interval lies to the left of 1.0, celecoxib is superior to naproxen with regard to the risk of the composite safety end point, and if the entire confidence interval lies to the right of 1.0, celecoxib is inferior to naproxen. Data are from Fleming.
See this image and copyright information in PMC

Comment on

  • Analyses of cancer data from three ezetimibe trials.
    Peto R, Emberson J, Landray M, Baigent C, Collins R, Clare R, Califf R. Peto R, et al. N Engl J Med. 2008 Sep 25;359(13):1357-66. doi: 10.1056/NEJMsa0806603. Epub 2008 Sep 2. N Engl J Med. 2008. PMID: 18765432
  • Intensive lipid lowering with simvastatin and ezetimibe in aortic stenosis.
    Rossebø AB, Pedersen TR, Boman K, Brudi P, Chambers JB, Egstrup K, Gerdts E, Gohlke-Bärwolf C, Holme I, Kesäniemi YA, Malbecq W, Nienaber CA, Ray S, Skjaerpe T, Wachtell K, Willenheimer R; SEAS Investigators. Rossebø AB, et al. N Engl J Med. 2008 Sep 25;359(13):1343-56. doi: 10.1056/NEJMoa0804602. Epub 2008 Sep 2. N Engl J Med. 2008. PMID: 18765433 Clinical Trial.

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