Potential of patient-reported outcomes as nonprimary endpoints in clinical trials

Blogger's Note: this paper is not specific to ovarian cancer


open access

Conclusions

Successful PRO (patient reported outcomes) labeling claims are typically based on primary endpoints assessing signs and symptoms. Based on this research, studies with PROs as primary endpoints are far more likely to facilitate positive regulatory review and acceptance of PROs in support of labeling claims. Although inclusion of PROs as nonprimary endpoints in clinical trials has its challenges, recent PRO labels granted by the FDA show that they can indeed be candidates for PRO labeling claims as long as they are supported by evidence.

Authors:

1 Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, USA
2 Health Solutions, 200 Park Offices Drive, Research Triangle Park, NC 27709, USA
3 RTI Health Solutions, 3005 Boardwalk St., Suite 105, Ann Arbor, MI 48108, USA