Development of a database for investigating characteristics and quality of published clinical trials in chronic...

Given the increasing long-term burden of chronic obstructive pulmonary disease (COPD), scientifically rigorous, efficient, and sustainable disease management has become a critical priority. However, the exponential proliferation of publications and the increasing granularity of research topics have amplified the difficulty of retrieving, integrating, and utilizing clinical evidence. Establishing a systematically curated, disease-specific clinical trial database can therefore provide a robust data foundation for diverse secondary research.

Using a combined strategy of individual-level literature searching and meta-epidemiological approaches, we systematically searched for primary clinical trial reports published before June 30, 2023. The literature data were sourced from PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Database, Wanfang Database, and China Biology Medicine Database (CBM). Trial data were extracted using the CONSORT reporting standards, and the risk of bias in clinical trials was assessed using the ROB 2.0.

In the search results, we identified 36,127 English RCTs and 142,670 Chinese RCTs, along with 4019 English meta-analyses and 3219 Chinese meta-analyses. Screening of the English-language literature was completed, and upon merging the two sets of search results, a duplication rate of 61.6% was found, resulting in the inclusion of 2261 primary trial reports. The included literature primarily focused on drug treatment [1087 (48.1%)] and pulmonary rehabilitation studies [607 (26.8%)]. Within drug treatment research, inhaled western medications garnered the most attention [684 (30.3%)], followed by oral western medications [299 (13.2%)].

This study preliminarily established a structured, manually curated database comprising 2261 English-language COPD clinical trials. Currently, the repository provides a preliminary stratification of these trials and illustrates the superior comprehensiveness of a dual-track retrieval strategy over a single search approach. Moving forward, the database will transition into an open-access research platform and be continuously updated to ensure its comprehensiveness and timeliness.