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. Author manuscript; available in PMC: 2014 May 14.
Published in final edited form as: N Engl J Med. 2013 Nov 14;369(20):1926–1934. doi: 10.1056/NEJMsa1300237

Table 2.

Trial Characteristics According to Status with Respect to Clinical-Event End Point and a Cost of $5 Million or More.

Variable Both Clinical-Event
End Point and
Cost ≥$5 Million
(N = 37)
Either Clinical-
Event End Point or
Cost ≥$5 Million
(N = 31)
Neither Clinical-
Event End Point nor
Cost ≥$5 Million
(N = 176)
Total cost (millions of $) 1356 264 402

Mean cost per trial (millions of $) 36.6 8.5 2.3

Characteristic of the trial (%)

  Multiple awards* 57 45 1

  Funded by contract or cooperative agreement 84 61 8

  Sample size ≥1000 84 26 6

  Behavioral intervention 14 45 66

  Cluster randomization 5 10 23

  Completion date before January 1, 2010 76 65 70

  Primary-end-point results

    Positive 16 39 45

    Negative 84 61 48

    Uncertain 0 0 7
*

This category does not include all multicenter trials, since some of those trials were funded through a single grant or contract.