How to avoid false con­clu­sions: FDA fi­nal­izes long-await­ed guid­ance on mul­ti­ple end­points in clin­i­cal tri­als

The FDA on Thurs­day fi­nal­ized guid­ance, first draft­ed in 2017, that will help spon­sors bet­ter un­der­stand FDA’s think­ing about the prob­lems posed by mul­ti­ple end­points in the analy­sis and in­ter­pre­ta­tion of clin­i­cal tri­al re­sults, and how these prob­lems can be bet­ter man­aged.

The 26-page guid­ance fea­tures var­i­ous strate­gies for group­ing and or­der­ing end­points for analy­sis and ap­ply­ing sta­tis­ti­cal meth­ods for man­ag­ing mul­ti­plic­i­ty to con­trol the chance of mak­ing er­ro­neous con­clu­sions about a drug’s ef­fects.

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