Pa­tient reg­istries may prove valu­able in reg­u­la­to­ry de­ci­sions, EMA study finds

Al­though pa­tient reg­istries can be het­ero­ge­neous in their qual­i­ty and de­sign, a new study in Drug Safe­ty co-au­thored by an EMA of­fi­cial ex­plains how pa­tient reg­istries could pro­vide valu­able da­ta for reg­u­la­to­ry de­ci­sions.

The au­thors ex­plain how such reg­istries can be used when ran­dom­ized con­trolled tri­als are not fea­si­ble, such as with some rare dis­eases, or to meet post­mar­ket­ing com­mit­ments.

“For prod­ucts grant­ed con­di­tion­al mar­ket­ing ap­proval, reg­istry stud­ies may pro­vide post-au­tho­ri­sa­tion da­ta to ful­fil reg­u­la­tor-im­posed spe­cif­ic oblig­a­tions to con­firm safe­ty and/or ef­fec­tive­ness, as is the case with the re­cent­ly au­tho­rised chimeric anti­gen re­cep­tor (CAR) T-cell prod­ucts, tia­gen­le­cleu­cel and axi­cab­ta­gene ciloleu­cel,” the study says.

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