De­cen­tral­ized tri­als: FDA lays out its think­ing in new draft guid­ance

With the rise and in­creas­ing ac­cep­tance of cost-cut­ting and po­ten­tial­ly more di­verse de­cen­tral­ized clin­i­cal tri­als, the FDA on Tues­day un­veiled a new draft guid­ance on the top­ic, of­fer­ing broad rec­om­men­da­tions on de­sign el­e­ments, the use of dig­i­tal health tech and po­ten­tial pit­falls.

The 16-page draft ex­plains how ful­ly de­cen­tral­ized tri­als (DCTs) — mean­ing the typ­i­cal tri­al-re­lat­ed ac­tiv­i­ties don’t oc­cur at cen­tral­ized sites like hos­pi­tals or doc­tors’ of­fices — may be ap­pro­pri­ate for in­ves­ti­ga­tion­al prod­ucts that are sim­ple to ad­min­is­ter or use, have well-char­ac­ter­ized safe­ty pro­files and do not re­quire com­plex med­ical as­sess­ments.

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