Gilead, Re­gen­eron, As­traZeneca and more en­cour­age FDA to ex­pand pa­tient re­port­ed out­come guid­ance

More than a half dozen top drug­mak­ers re­cent­ly called on the FDA to ex­pand its think­ing on pa­tient re­port­ed out­comes in can­cer tri­als to in­clude more in­for­ma­tion on PROs in open-la­bel and sin­gle arm tri­als, which are com­mon in on­col­o­gy, and to con­sid­er the ram­i­fi­ca­tions of spon­sors col­lect­ing PRO da­ta ear­ly in a drug’s de­vel­op­ment process.

The 8-page draft guid­ance from June out­lines FDA’s ex­pec­ta­tions for how this da­ta on symp­toms and func­tion­al im­pacts may aid the agency’s ben­e­fit/risk as­sess­ments. The guid­ance dis­cuss­es PRO in­stru­ment con­sid­er­a­tions and ex­am­ples of core PROs, as well as what tri­al spon­sors should con­sid­er when de­ter­min­ing the fre­quen­cy of PRO as­sess­ment for core PROs, and when PRO da­ta might make it in­to a prod­uct’s la­bel.

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