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 efficacy | p value required by 1 trial to provide the same strength of evidence | PARADIGM-HF p value for primary end point | PARADIGM-HF p value for CV death |
|---|---|---|---|
| 1 trial | 0.05 | ||
| 2 trials* | 0.00125* | 0.00008 (equivalent to 2–3 trials at p<0.05) | |
| 3 trials | 0.00003125 | ||
| 4 trials | 0.00000078 | 0.0000004 (equivalent to 4–5 trials at p<0.05) | |
| 5 trials | 0.0000000195 |
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.