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Review
. 2022 Sep:120:106860.
doi: 10.1016/j.cct.2022.106860. Epub 2022 Jul 25.

A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018)

Ari Gnanasakthy  1 , Jon Russo  2 , Kajan Gnanasakthy  2 , Nimanee Harris  2 , Colleen Castro  2
Affiliations
Review

A review of patient-reported outcome assessments in registration trials of FDA-approved new oncology drugs (2014-2018)

Ari Gnanasakthy et al. Contemp Clin Trials. 2022 Sep.

Abstract

The Food and Drug Administration (FDA) encourages the assessment of patient-reported outcomes (PROs) in oncology clinical trials. A 2015 review showed that approximately 26% of industry-sponsored oncology trials included assessment of PROs. However, the proportion of recent trials that supported new oncology drug approvals and assessed PROs is unknown. This review found that assessment of PROs was included in about 75% of registration trials that supported 55 new FDA drug approvals during 2014-2018. Patient-reported outcome assessment was included more in randomized controlled trials than in open-label trials (88% vs. 69%, respectively) and more in phase 3 than in phase 2 trials (89% vs. 66%, respectively).

Keywords: Patient reported outcome; Quality of life; United States Food and Drug Administration.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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