OBJECTIVES:

In February 2000, the NIH National Library of Medicine developed ClinicalTrials.gov, a now widely used database of publicly and privately funded clinical studies around the world. Real-world evidence (RWE) studies are types of clinical studies that have burgeoned into a widely used tool to inform healthcare decision making. Study registration is important for transparency, replicability, and RWE synthesis purposes. The exact frequency and trends in RWE registrations in the ClinicalTrials.gov database bears further examination.

METHODS:

Clinical study metadata was extracted from ClinicalTrials.gov by selecting the years 2015-2022 (each year 01/01-12/31) and using the search terms using the Boolean logical operator OR: “real world evidence”, “real world data”, “real world database”, “observational AND real”, “real world”, and “real data”. The data was further analyzed by study year, disease state/area, design status as prospective or retrospective, percent mentioning “RWE” in the title, percent mentioning “Registry” in title, percent of RWE studies being considered pilot or exploratory, as well as average study duration using survival analysis.

RESULTS:

5214 unique studies were extracted from the ClinicalTrials.gov database. In 2015 there were 411 found representing 1.71% of clinical studies registered to start that year. These numbers increased every year (except for small decreases in 2018) until 2022 at 927 studies representing 2.88% of clinical studies starting in that year. A similar trend was found in the percent mentioning “RWE” in the title; with 15.33% (63/411) in 2015 increasing every year to 20.39% (189/927) in 2022. Other results support increasing registration for retrospective database studies, but little for exploratory studies.

CONCLUSIONS:

The data trends show that RWE studies have become increasingly common in the ClinicalTrials.gov database with the percentage of studies with RWE mentioned in the title also increasing. Further research will compare registration in ClinicalTrials.gov versus other registries.