Aligning Clinical Trial Reporting: A systematic analysis and position statement by the International Consortium for MDS

Variability in how clinical trial elements are reported can hinder accurate interpretation and comparison of trial results. Here, we systematically analyzed published manuscripts of therapeutic clinical trials in myelodysplastic syndromes/neoplasms (MDS) focusing on how key data elements were reported and made recommendations on how to improve this reporting. We included peer-reviewed full text manuscripts that reported results of clinical trials in MDS and were published between January 1, 2015 to December 31, 2024. We analyzed the presence or absence of several pre-determined key reporting elements and then synthesized these data to evaluate for consistency across manuscripts. We identified substantial variability in descriptions of patient characteristics, as well as the definitions used for response criteria. For example, baseline ANC was reported in only 16% of lower-risk MDS studies and 23% of higher-risk MDS studies, while baseline bone marrow blast percentage was reported in only 55% of higher-risk MDS manuscripts. In addition, response endpoints lacked standardization, with six unique definitions of RBC transfusion independence identified in lower-risk MDS trials and seven different definitions of overall response rate identified in higher-risk MDS trials. Informed by the results of this analysis, we then performed a modified-Delphi process for members of the International Consortium for MDS (icMDS) to develop consensus-based recommendations for consistent and accurate reporting of MDS clinical trial results. We advocate that these recommendations serve as benchmarks and templates for clinical trial reporting in MDS to improve interpretability and comparison of results.