• Journal Article

Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints


Gnanasakthy, A., Sadrick, A., Eghbal-Ahmadi, M., & DeMuro, C. (2014). Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints. Therapeutic Innovation & Regulatory Science, 48(5), 557-563. DOI: 10.1177/2168479014536409


Introduction: Patient-reported outcomes (PROs) play an increasingly pivotal role in confirmatory clinical trials with pressures to develop drug differentiation strategies. Claims based on primary endpoints that are included in the product label are likely to be fully promoted by the manufacturers; however, the extent to which manufacturers promote claims based on secondary PRO endpoints is unknown. The purpose of this review is to assess the extent of promotion of PRO label claims for 6 pharmaceutical products with nonprimary PRO endpoints. Methods: Six products were reviewed that received PRO label claims based on nonprimary PRO endpoints between 2006 and 2008. Promotional documents distributed in the United States by the drug manufacturers between the year of launch and 2011 were identified from a PharmaVoxx database. Circulation of these documents was calculated according to quarterly distributions. Two researchers reviewed the documents using standard criteria. Promotional activities based on nonprimary PRO endpoint claims were compared with total number of messages. Results: Manufacturers of the 6 products distributed 973 unique promotional documents 2998 times. Messages based on primary endpoints were distributed 1798 times, whereas messages relating to nonprimary PRO endpoints were distributed 1200 times (40% of distributions) and varied among products (4%-70%). Messages relating to PROs were targeted mostly at patients and consumers (65%) versus physicians and health care professionals (34%). Conclusions: Promotion of PRO messages based on nonprimary endpoints is much lower than those based on primary endpoints, suggesting that manufacturers do not always optimize the potential of PRO messages