RWD and RWE are not the same: FDA leaders dispel common misconceptions in new paper

In a com­men­tary pub­lished Thurs­day, sev­er­al top FDA of­fi­cials of­fered in­sight in­to a key ques­tion when it comes to con­duct­ing clin­i­cal tri­als: How should re­al-world da­ta trans­late in­to re­al-world ev­i­dence?

The au­thors, led by Motiur Rah­man, a se­nior epi­demi­ol­o­gist in the FDA’s drug cen­ter, ex­plained how the terms re­al-world da­ta (RWD) and re­al-world ev­i­dence (RWE) are fre­quent­ly used in­con­sis­tent­ly or in­ter­change­ably, in­clud­ing in sub­mis­sions re­ceived by the agency.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.