Systematic review of real-world evidence studies in women’s cancer at key congresses and factors related to high tier acceptance.

Abstract

e17533 Background: Real-world evidence (RWE) studies complement clinical trials (CT) and address a variety of issues, such as adherence, cost, comparative effectiveness, and treatment patterns. This systematic review assessed prevalence and characteristics of RWE presented at oncology congresses. Methods: Data on women’s cancers (cervical, ovarian, endometrial, and multiple [gyn/other]) work were extracted from the databases of American Society of Clinical Oncology (ASCO) and The Society of Gynecological Oncology (SGO) congresses (2018-2020). The primary objective was to identify the proportion of CT vs RWE. Secondary objectives were to: a) describe the tier of acceptance for RWE vs CTs; b) describe prevalence of types of RWE; c) analyze the characteristics (data source, design, authorship, outcome(s) assessed, and presence of statistically significant results) associated with RWE acceptance. Results: Of 3163 abstracts screened, 2271 were included (1756 RWE vs 515 CTs). RWE represented a higher proportion of work at SGO vs ASCO (90% vs 59%). Overall, more RWE vs CTs was accepted as a poster (75% vs 60%) or publication only (19% vs 11%), while less was accepted for oral presentation (4% vs 20%). Among RWE, 90% had academic author(s), 44% used clinical data, around one quarter used another data repository/registry, and about 14% used medical record or chart review data. Nearly two thirds of RWE studies reported significant results, while 6% contained no significant results. There was no clear association between authorship or significance of results and tier of acceptance. About 60% of RWE studies were retrospective, 9% were prospective, 4% focused primarily on PROs, and 2% were economic models. The most common outcomes assessed in RWE studies were molecular analyses (18%) and survival based on treatment efficacy (13%). Among molecular analyses, most (68%) were accepted as a poster, with 26% accepted as publication only and 4% as oral. An even greater fraction (77%) of survival/efficacy analyses were accepted as a poster, 18% as publication only and even fewer (2%) as oral. Conclusions: RWE was more frequently presented than CTs at both ASCO and SGO. However, across congresses and cancer types, a smaller proportion of RWE vs CT work was accepted as an oral presentation. Results indicated high interest in CTs; RWE studies utilizing clinical data or data repository/registry data, and those with molecular and/or survival outcomes, were most common. The results demonstrate that while RWE studies are prevalent and provide valuable data for healthcare decision-making, they do not always achieve the visibility of CTs.[Table: see text]