FDA dips its toe in­to the world of pa­tient-re­port­ed out­comes for can­cer tri­als

While ac­knowl­edg­ing the chal­lenge of en­sur­ing pa­tient-re­port­ed out­come (PRO) da­ta in can­cer drug ap­pli­ca­tions are con­sis­tent and of high qual­i­ty, the FDA on Wednes­day out­lined its ex­pec­ta­tions for how this da­ta on symp­toms and func­tion­al im­pacts may aid the agency’s ben­e­fit/risk as­sess­ments.

Can­cer drug tri­als typ­i­cal­ly em­ploy stan­dard­ized ef­fi­ca­cy as­sess­ments of over­all sur­vival and tu­mor re­duc­tion mea­sures, in ad­di­tion to close­ly track­ing any ad­verse events to eval­u­ate a new drug’s safe­ty and ef­fi­ca­cy bal­ance. But the FDA is al­so look­ing to bet­ter em­ploy a core set of PROs to ad­dress dis­ease symp­toms, symp­to­matic ad­verse events, and phys­i­cal func­tion, all of which may be im­por­tant con­trib­u­tors to a pa­tient’s qual­i­ty of life.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER