FDA drafts guid­ance on seam­less clin­i­cal tri­als for can­cer drug de­vel­op­ers

The FDA on Fri­day re­leased draft guid­ance to help spon­sors de­sign and con­duct first in hu­man (FIH) clin­i­cal tri­als that speed the clin­i­cal de­vel­op­ment of can­cer drugs through mul­ti­ple ex­pan­sion co­hort study de­signs.

The guid­ance pro­vides the FDA’s thoughts on the char­ac­ter­is­tics of drugs and bi­o­log­ics ap­pro­pri­ate­ly suit­ed for such an ex­pe­dit­ed plan, in­for­ma­tion to in­clude in such in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion sub­mis­sions, when to in­ter­act with the FDA and safe­guards to pro­tect pa­tients en­rolled in FIH ex­pan­sion co­hort stud­ies.

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