Abstract 2515: Enhancing oncology data collection and submission: The value of the national cancer institute (NCI) oncology codetable mapping file

Abstract Data collection for efficacy endpoints in oncology clinical trials present various challenges and thus require adapted strategies and tools. Use of the Guidances to follow for surrogate endpoint analysis and reporting, such as RECIST, Lugano, RANO or others are straightforward, as this depends on the target malignancies and the type of compound being studied. It is however challenging to ensure that, once the endpoints for a trial are selected, the method for their collection and identification be clearly defined. This paper will focus on the use of the tools developed by the NCI and CDISC communities to ensure that data be efficiently collected and organized, in line with regulatory requirements. We will be explaining the role of the following tools which are used throughout a trial, starting with the protocol design and all the way until the final reporting:- CDASH Implementation Guide (CDASHIG) : this refers to the guidances for data collection- SDTM Implementation Guide (SDTMIG) : this refers to the guidances for data submission- Therapeutic Area User Guides (TAUGs) : these include disease-specific metadata, examples and guidances on implementing CDISC standards for a variety of uses, including global regulatory submissions (ie : Breast Cancer, Prostate Cancer, Colorectal Cancer, Lung Cancer) It is of particular interest to evaluate the value added of the NCI Oncology Codetable Mapping File in oncology clinical trials, as demonstrated through its use in EDC and database design. We will describe the approach taken to integrate this new tool into EDC and Database design and this enables further alignment with guidelines (e.g. RECIST, Lugano), controlled terminologies and Regulator expectations. We will also investigate the value added for investigator sites, who can benefit from this further standardization of data collection practices across clinical trials, regardless of sponsor or CRO, to simplify their working practices.As a conclusion, we will summarize the value added by the NCI Oncology Codetable Mapping File to the existing landscape (CDISC tools, Surrogate Endpoint Guidances) of oncology clinical trials. We will emphasize its potential to simplify complex data requirements for topics specific to the field of oncology. Citation Format: Karine Provost, Stephanie Le Goaller, Mathieu Grace, Pierre Montagne. Enhancing oncology data collection and submission: The value of the national cancer institute (NCI) oncology codetable mapping file [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2515.