Abstract PO1-10-11: Illuminating Breast Cancer Clinical Trials: Unpublication Rates, Causes , and Recommendations

Abstract

Abstract Introduction: Breast cancer stands as the most prevalent cancer among women worldwide. Recent years have witnessed remarkable improvements in patient’s outcome, primarily attributed to advancements in management strategies. However, the introduction of novel management approaches necessitates rigorous evaluation through clinical trials, ensuring both their safety and effectiveness. Conducting these trials entails significant financial investments and time commitments, making them susceptible to termination for various reasons. This study aims to investigate the factors that contribute to an increased likelihood of breast cancer clinical trial termination. Methodology: A thorough and extensive exploration of ClinicalTrials.gov was undertaken in order to discover completed clinical trials focused on treating breast cancer from 2000 to 2020. By employing the distinctive National Clinical Trial number (NCT) identifier, trial's status; whether completed or terminated, was determined. Subsequently, a meticulous evaluation was carried out on these trials to ascertain the factors that contributed to their termination. In order to unveil the noteworthy factors linked to publication, a comprehensive analysis encompassing both univariate and multivariate approaches was conducted. Results: During the specified period, a noteworthy number of oncology clinical trials, totaling 9,145, were conducted. Among them, 12.3% (n=1,127) were focused on breast cancer. These breast cancer trials managed to recruit an impressive 2,669,749 patients. However, it is concerning to note that a significant portion, 38.1% (n=429), of the breast cancer trials did not result in published findings, despite enrolling a considerable number of patients (n= 2,397,179). Our comprehensive univariate analysis revealed several significant associations between the characteristics of clinical trials and their likelihood of going unpublished (P< 0.001). Factors such as funding, phase, masking, center type (single vs multi), and country of conduct were all found to have a statistically significant impact on the publication status. Furthermore, our meticulous multivariate analysis demonstrated that certain criteria were associated with higher odds of publication. These included trials that recruited >50 patients, multicenter trials, studies implemented masking, phase-3 trials and those that included low- and middle-income countries (LMIC), Table. Conclusion: Our findings indicate that the unpublication rate of clinical trials was alarmingly high. We identified that the sample size, masking, multicenter involvement and phase of the trial impact significantly on publication rate . This knowledge can be valuable for researchers, funding agencies, and other stakeholders who can prioritize resource allocations and improve patients care. Table: Multivariate analysis, factors that impact publication rate Citation Format: Abdulrahman Alhajahjeh, Ghayda’ Bader, Saji Aweidah, Taima’ Bader, Basil Abdin, Layla El-Amayreh, Hikmat Abdel-Razeq. Illuminating Breast Cancer Clinical Trials: Unpublication Rates, Causes , and Recommendations [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-10-11.