Table 1

Number of trials with a p value <0.05 to provide the same level of evidence as PARADIGM-HF on the primary outcome and cardiovascular death

Number of trials with p<0.05 showing efficacyp value required by 1 trial to provide the same strength of evidencePARADIGM-HF p value for primary end pointPARADIGM-HF p value for CV death
1 trial0.05
2 trials*0.00125*0.00008 (equivalent to 2–3 trials at p<0.05)
3 trials0.00003125
4 trials0.000000780.0000004 (equivalent to 4–5 trials at p<0.05) 
5 trials0.0000000195
  • Based on the formula (0.025)n×2 where n is the number of trials required (S Pocock personal communication 2015).

  • *Usual regulatory requirement—2 trials at p<0.05 or 1 trial at p<0.00125.