OBJECTIVES: As the demand for real-world evidence (RWE) increases to support healthcare decisions, similar standards for transparency of methodology and reporting need to be applied to both RCT and RWE studies. This study aimed to quantify the current transparency of reporting through study registration of RWE studies of treatment and/or comparative effectiveness, as recommended by the Joint ISPOR‐ISPE Special Task Force.

METHODS: A descriptive analysis of publications in cardiovascular disease assessed 50 most recent RCTs and RWE studies of treatment and/or comparative effectiveness, using an Embase^® search on May 11, 2018. We assessed inclusion of a study registration identifier in the abstract of publications, as well as type of treatment, sponsorship, and region of study.

RESULTS: Of abstracts reporting RWE studies that qualified for registration, 6% (3/50) had study registration identifiers, which contrasted with 68% (34/50) of RCT abstracts. RWE abstracts with identifiers comprised a prospective observational study, an interventional clinical practice study, and a pragmatic trial. Notably, 32% (16/50) of RCT study abstracts did not include the trial identifier; most of these were studies performed in Asia (7/16) and Africa (2/16). Proportionally, the highest study registration for RWE reported on behavioral interventions (33%, 2/6) with 5% (1/22) on pharmaceutical treatment. Studies sponsored by pharma had the highest registration proportion for both RWE (29%, 2/7) and RCT studies (82%, 14/17). Two RWE studies were registered on clinicaltrials.gov and one on umin.ac.jp/ctr/. As this study was geared toward reporting of RWE study registration, we selected cardiovascular disease, which had the highest number of RWE studies registered on clinicaltrials.gov.

CONCLUSIONS: The low study registration of RWE studies (6%) provides a baseline assessment of adherence to the 2017 ISPOR-ISPE good practice recommendations, and supports a call to action to improve transparency of RWE studies of treatment and/or comparative effectiveness through study registration.