How No­var­tis as­sess­es a drug's prob­a­bil­i­ty of suc­cess pri­or to the piv­otal tri­al

Tran­si­tion­ing a de­vel­op­ing com­pound from ear­ly phase clin­i­cal tri­als to a piv­otal tri­al(s) can be a make-or-break de­ci­sion for a small- or medi­um-sized phar­ma. And some­times com­pa­nies aren’t very good at mak­ing the right de­ci­sion.

While many com­pa­nies of­ten re­ly on out­dat­ed ways to as­sess the prob­a­bil­i­ty of any giv­en com­pound’s suc­cess in mak­ing that tran­si­tion, and clear­ly some are bet­ter than oth­ers — an ac­com­pa­ny­ing ed­i­to­r­i­al ex­plains how Pfiz­er’s “end to end” suc­cess is “al­most twofold high­er than the in­dus­try bench­mark” — No­var­tis sci­en­tists re­cent­ly pub­lished in the May is­sue of Clin­i­cal Phar­ma­col­o­gy & Ther­a­peu­tics its frame­work for as­sess­ing the prob­a­bil­i­ty of suc­cess at the end of a small­er Phase II tri­al, or pri­or to that piv­otal tri­al.

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