Abstract

Abstract Background. Inaccuracy and widespread deficiencies in the reporting of translational cancer genomic studies is common and represents a major issue of cancer research. It challenges not only the study interpretation but also the ability to accurately compare studies. The REMARK (REporting recommendations for tumour MARKer prognostic studies) guideline was previously developed to improve the reporting of tumour biomarker prognostic studies. However, it presents several limitations as many aspects of omic-based research are missing. We developed a new guideline to ensure transparency and standardized reporting of clinical cancer genomic studies. Methods. The concept for this checklist was generated after extensive review of current literature which identified major gaps in study reporting, including: insufficient information about study design, population included, and treatments; inappropriate analysis methods; and widespread deficiencies in the reporting of results. Key elements to be addressed in the new checklist were identified by experts in methodology, biostatistics, and preclinical, translational, and clinical cancer genomics (proposing panel). Several reporting guidelines produced for other types of medical research studies were also reviewed. Results. A preliminary draft of the proposed checklist was discussed during the 18th workshop of the International Cancer Genome Consortium (ICGC) in Verona, Italy (13-14 June 2022). Building on that work, the checklist was then re-discussed and improved by the proposing panel. This will serve as a starting point for further discussion among the ICGC, REMARK, the Catalogue Of Somatic Mutations In Cancer (COSMIC), the International Quality Network for Pathology (IQN Path) and other organizations to collect any criticisms, make further revisions, and reach final consensus. Conclusions. The proposed guideline provides a comprehensive overview to educate on good reporting of translational cancer genomic studies. It represents a valuable reference to consider when designing, conducting, and reporting this kinds of studies. After ICGC, REMARK, COSMIC, and IQN Path discussion, revision, and approval, the proposed checklist will be the new standard to be adopted by researchers, editors and reviewers. It will significantly impact future cancer research and patient care. Citation Format: Raffaella Casolino, Philip A. Beer, Nicola Normanno, Zbyslaw Sondka, Andrew V. Biankin. Reporting recommendations for translational cancer genomic studies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 2112.

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