When can RWE trans­late in­to cred­i­ble ev­i­dence? EMA of­fi­cials dis­cuss

Re­al-world ev­i­dence (RWE) may pro­vide an op­por­tu­ni­ty to learn more about a drug’s ben­e­fits and risks, but of­fi­cials from the EMA said in an ar­ti­cle pub­lished Tues­day in Clin­i­cal Phar­ma­col­o­gy & Ther­a­peu­tics that there will need to be ad­e­quate sta­tis­ti­cal meth­ods to ex­tract, an­a­lyze and in­ter­pret RWE be­fore they can trans­late in­to cred­i­ble ev­i­dence.

In or­der to en­sure that any new an­a­lyt­i­cal meth­ods are ac­cept­able for reg­u­la­tors, the EMA au­thors say they will re­quire test­ing and val­i­da­tion in near­ly the same way as a new med­i­cine is eval­u­at­ed: “prospec­tive­ly, well-con­trolled and ac­cord­ing to pre-agreed plan.”

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