PRM115 - Use Of Work Productivity Endpoints In Clinical Studies: A Review By Disease State And Measurement Type

Abstract

Productivity outcomes are of interest because they describe the consequence of disease in the workplace and impact on productivity. We conducted an analysis of work productivity (WP) endpoints in clinical studies. A keyword search was conducted on Clinicaltrials.gov for “work productivity” to identify relevant studies. Trials with terminated, withdrawn, or suspended status, those with non-drug interventions, and those without WP endpoints were excluded from analysis. A total of 170 studies were included (113 interventional and 57 observational studies). Of the 170 studies included, 44% were performed outside of the US, 31% were multinational studies including the US, and 25% were conducted exclusively in the US. The most common therapeutic categories investigated were autoimmune diseases (37%), neurology (14%), and psychiatry (9%). Most studies (84%) were sponsored by pharmaceutical manufacturers, with 11% sponsored by other institutions, or a combination of both (6%). The majority of trials investigated WP as a secondary measure (89%), with several, primarily observational studies, reporting WP as a primary outcome (11%). Survey instruments were utilized most commonly, representing 82% of studies, while 9% of studies evaluated WP based on time missed from work. Some studies utilized multiple measures. Generic instruments, such as the Work Productivity and Activity Impairment Questionnaire (WPAI), were used in 54% of studies, while 29% used disease-specific measures. In some cases (15%) a specific tool or instrument for WP was not identified. Most trials (93%) included other patient-reported endpoints, in addition to WP. WP endpoints were most commonly investigated in manufacturer-sponsored trials as secondary outcomes to demonstrate patient benefit in therapeutic areas where more concrete clinical outcomes are limited. Generic instruments are heavily utilized, with approximately one-third of studies utilizing disease specific measures.