Abstract 6464: Real-world evidence (RWE) presented at AACR annual meetings: A 10-year trend analysis

Abstract

Abstract Introduction: RWE is increasingly used in the oncology community, particularly following the 2016 21st Century Cures Act. A recent analysis of RWE presented at ASCO reported a significant increase in relative frequency of RWE abstracts from 2011-2021[1]. We conducted a similar trend analysis of RWE presented at AACR and predictive factors associated with publication. Methods: EMBASE was queried for abstracts presented at AACR 2013-2022, using terms related to study designs and methodologies that employ use of RWE. Details on study design, location, data source, patient number, cancer site, analytical approach, endpoints, and presentation type (oral vs. poster) were extracted and analyzed. Searches in Google Scholar identified published manuscripts associated with each abstract. The Cochran-Armitage trend test and Monte-Carlo estimation of the exact test were used to detect trends over time; p-values are provided for descriptive purposes. Relative risk ratios were calculated to determine statistically significant predictors of publication. Results: Of 56,920 total abstracts presented at AACR from 2013-2022, 611 (1.1%) RWE abstracts were identified. The proportion of presented abstracts with RWE increased from 0.6% in 2013 to 2.0% in 2022 (p<0.001). Among the RWE abstracts, use of electronic medical record (2013: 0% vs. 2022: 9.3%; p=0.002) and genomics databases (i.e., GENIE) (2013: 0% vs. 2022: 8.3%; p=0.006) increased over time. While majority of RWE abstracts were presented as posters (95.9%), the proportion of oral presentations increased in the last decade (2013: 0.0% vs. 2022: 3.7%; p=0.005). Abstracts with sample sizes <500 decreased significantly over time (p=0.002); those with sample sizes 5,000-<50,000 increased significantly over time (p=0.001). The proportion of abstracts including multiple cancer sites (vs. single-site) increased from 5.1% in 2013 to 20.4% in 2022 (p<0.001). The most common cancer sites were lung, breast, and colorectal. Statistically significant factors associated with publishing an abstract into a manuscript included study sample size 500-<5,000 or ≥100,000, inferential statistics (vs. descriptive), propensity score matching, and effectiveness or disease burden endpoints.Conclusion: RWE studies presented at AACR increased in the recent decade, with more robust study designs, incorporation of novel clinico-genomic databases such as GENIE, and advanced analytical approaches. These findings suggest the value of RWE has been increasingly recognized by the oncology research community and that RWE is being used to provide critical insights and inform patient care. Given FDA’s recent guidance on RWE to support regulatory decision-making, this trend will likely continue. [1] Azad Fet al. Longitudinal trends of real-world evidence (RWE) reporting in oncology conferences: An 11-year ASCO Annual Meeting analysis. Citation Format: Jihong Zong, Lauren C. Bylsma, Orsolya Lunacsek, Jon Fryzek. Real-world evidence (RWE) presented at AACR annual meetings: A 10-year trend analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 6464.