OBJECTIVES

: The use of patient reported outcomes (PROs) in medical device studies have been increasing and signals a shift towards value-based purchasing in Europe. Currently, there is no requirement to include PROs in medical device studies for regulatory purposes in Europe or the United States (US). However, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a report in 2016-2017 encouraging the use of PROs in medical devices. This study investigates the use of PROs in medical devices in clinicaltrials.gov to assess the frequency and type of PROs used.

METHODS

: Using clinicaltrials.gov, clinical trials were identified using device as a search term and filtering by study phase (phase 3 and 4), recruitment status (not yet recruiting, recruiting, enrolling by invitation, active not recruiting, completed, unknown status), and funding (industry). The primary and secondary endpoints were reviewed for PROs once the trials were identified. Trials were excluded if PROs were not used as a study outcome, or if the study was suspended, terminated, or withdrawn.

RESULTS

: Two hundred studies (n=15 phase 2/3, n=102 phase 3, n=83 phase 4) were identified. Twenty three (12%) studies started in 2017 or later. Sixty-one (31%) of the studies included a PRO as a primary or secondary outcome. Sixteen percent of the studies (n=32) included a PRO as a primary outcome and 24% (n=49) studies included PROs as secondary outcome. A variety of PROs were used including both general and disease-specific measures. Fifteen studies included a pain PRO.

CONCLUSIONS

: Although many publications indicate an increase of PRO use in medical device studies, findings from this research demonstrate that most studies in this space are not including PROs.