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Applications of genomics in the design and implementation of cancer clinical trials: towards a new era in clinical research
Aplicaciones de la genómica en el diseño e implementación de ensayos clínicos oncológicos: hacia una nueva era en la investigación clínica
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Sanchez N, Gutierrez-Babativa L, Cardona A. Applications of genomics in the design and implementation of cancer clinical trials: towards a new era in clinical research. Rev. colomb. hematol. oncol. [Internet]. 2026 Feb. 17 [cited 2026 Feb. 18];13(1-Supl):491-505. https://doi.org/10.51643/22562915.832
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Sanchez N, Gutierrez-Babativa L, Cardona A. Applications of genomics in the design and implementation of cancer clinical trials: towards a new era in clinical research. Rev. colomb. hematol. oncol. [Internet]. 2026 Feb. 17 [cited 2026 Feb. 18];13(1-Supl):491-505. https://doi.org/10.51643/22562915.832
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Introduction: genomics has transformed clinical cancer research by enabling detailed molecular characterization of tumors. This has driven the development of more precise clinical trial designs to evaluate targeted therapies in specific molecular subgroups, overcoming the limitations of traditional, organ-based approaches.
Methods: a narrative review of the scientific literature published between 2008 and 2024 was conducted, focusing on original studies, systematic reviews, and clinical guidelines that address the use of genomics in the design, execution, and interpretation of clinical trials. Emphasis was placed on solid and hematologic malignancies, including basket, umbrella, and adaptive trial designs.
Results: the incorporation of genomic biomarkers has enabled innovative trial designs, such as tumor-agnostic studies, allowing patient selection based on molecular alterations regardless of tumor histology. Trials like NCI-MATCH, SHIVA, TAPUR, and I-SPY2 show that this approach enhances response rates and accelerates drug development. However, challenges remain regarding biomarker validation, genomic data management, access disparities, and clinical interpretation of variants.
Conclusion: the integration of genomics into clinical trials is a cornerstone of precision oncology. Implementing innovative trial designs requires collaborative efforts across technology, bioinformatics, regulatory frameworks, and ethics to ensure effective and equitable application in clinical research.
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