FDA updates draft guidance on race and ethnicity reporting in clinical trials

The FDA pub­lished draft guid­ance on Mon­day di­rect­ing clin­i­cal tri­al spon­sors to in­clude race and eth­nic­i­ty in­for­ma­tion on their pro­posed prod­uct la­bel­ing, and to add ob­ser­va­tion­al stud­ies to the scope of clin­i­cal tri­als that are cov­ered by the guid­ance.

The 11-page doc­u­ment, once fi­nal­ized, will re­place the 2016 draft guid­ance ti­tled “Col­lec­tion of Race and Eth­nic­i­ty Da­ta in Clin­i­cal Tri­als.” The doc­u­ment is meant to guide drug­mak­ers as they choose pa­tients for clin­i­cal tri­als, and al­so how they re­port da­ta from them.

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