FDA’s decentralized trial guidance: PhRMA, Mayo Clinic and others seek tweaks

Af­ter the FDA this past spring laid out its ap­proach to de­cen­tral­ized clin­i­cal tri­als, stake­hold­ers are large­ly wel­com­ing the guid­ance, but are ask­ing the agency to re-ex­am­ine sev­er­al as­pects, in­clud­ing al­low­ing more flex­i­bil­i­ty in clin­i­cal tri­al de­sign and loos­en­ing the rec­om­men­da­tion that par­tic­i­pant in­for­ma­tion be stored at a phys­i­cal lo­ca­tion.

In a broad-rang­ing draft guid­ance pub­lished May 2, the FDA di­rects spon­sors to com­mu­ni­cate with agency staff ear­ly on to parse through the specifics of their tri­al de­sign, and it lays out a roadmap for how to col­lect da­ta and in­volve health­care providers. The FDA re­ceived 85 com­ments on the guid­ance by the time the com­ment pe­ri­od closed on Tues­day.

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