FDA, Ae­tion part­ner on re­al-world da­ta an­a­lyt­ics for Covid-19

The FDA on Tues­day said it will part­ner with New York-based health tech­nol­o­gy firm Ae­tion, Inc. to de­vel­op re­al-world da­ta an­a­lyt­ics to an­swer press­ing ques­tions re­lat­ed to coro­n­avirus dis­ease (Covid-19).

Amy Aber­nethy

“Eval­u­a­tion of re­al-world da­ta has the po­ten­tial to pro­vide a wealth of rapid, ac­tion­able in­for­ma­tion to bet­ter un­der­stand dis­ease symp­toms, de­scribe and mea­sure im­mu­ni­ty and un­der­stand avail­able med­ical prod­uct sup­plies to help mit­i­gate po­ten­tial short­ages. These da­ta can al­so in­form on­go­ing work to eval­u­ate po­ten­tial ther­a­pies, vac­cines or di­ag­nos­tics for COVID-19,” said FDA Prin­ci­pal Deputy Com­mis­sion­er Amy Aber­nethy.

The col­lab­o­ra­tion will re­ly on Ae­tion’s Ev­i­dence Plat­form to an­a­lyze re­al-world da­ta sources such as elec­tron­ic health records, in­sur­ance claims, pa­tient reg­istries and lab re­sults to help in­form the agency’s re­sponse to the pan­dem­ic.

“We can use cur­rent da­ta and learn what de­ci­sions we can con­fi­dent­ly make now, and we can learn what we’ll need to do in the fu­ture as more da­ta be­come avail­able,” Aber­nethy said.

Found­ed in 2013 by Har­vard Med­ical School fac­ul­ty, Ae­tion has pre­vi­ous­ly worked with FDA on re­search in­ves­ti­gat­ing how re­al-world ev­i­dence can be used to in­form reg­u­la­to­ry de­ci­sion-mak­ing and counts for­mer FDA Com­mis­sion­er Scott Got­tlieb as a mem­ber of its board of di­rec­tors.

FDA says the col­lab­o­ra­tion fits in with oth­er ef­forts to pull da­ta from dif­fer­ent sources amid the pan­dem­ic, in­clud­ing its Sen­tinel ini­tia­tive and the Rea­gan-Udall Foun­da­tion and Friends of Can­cer Re­search Covid-19 Ev­i­dence Ac­cel­er­a­tor.

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