Stake­hold­ers weigh in on big da­ta at EMA fo­rum

Ef­fec­tive use of re­al-world da­ta and oth­er da­ta gath­ered out­side the clin­i­cal tri­al are­na re­quires a uni­fied, big-pic­ture ap­proach, ac­cord­ing to a new re­port from the first-ever big da­ta stake­hold­er fo­rum held by the EMA.

The reg­u­la­tor’s re­port on the Dec. 15 fo­rum high­light­ed the im­por­tance of col­lab­o­ra­tion in ad­dress­ing some of the chal­lenges of bring­ing re­al-world da­ta (RWD) in­to the drug de­vel­op­ment process. Some of these in­clude da­ta qual­i­ty, the need for ro­bust study meth­ods, and “es­tab­lish­ing the ev­i­den­tiary val­ue and reg­u­la­to­ry ac­ces­si­bil­i­ty of ev­i­dence gen­er­at­ed.”

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