Resource requirements to accelerate clinical applications of next-generation sequencing and radiomics: workshop commentary and review

Lyndsay Harris; Lalitha K Shankar; Claire Hildebrandt; Wendy S Rubinstein; Kristofor Langlais; Henry Rodriguez; Adam Berger; John Freymann; Erich P Huang; P Mickey Williams; Jean Claude Zenklusen; Robert Ochs; Zivana Tezak; Berkman Sahiner

doi:10.1093/jnci/djae136

Resource requirements to accelerate clinical applications of next-generation sequencing and radiomics: workshop commentary and review

J Natl Cancer Inst. 2024 Oct 1;116(10):1562-1570. doi: 10.1093/jnci/djae136.

Authors

Affiliations

¹ Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
² Cancer Imaging Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
³ Breast and Gynecologic Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁴ Office of In Vitro Diagnostics (OHT7), Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
⁵ Office of Cancer Clinical Proteomics Research, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁶ Division of Clinical and Healthcare Research Policy, Office of Science Policy, National Institutes of Health, Bethesda, MD, USA.
⁷ Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Cancer Imaging Program, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁸ Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁹ Leidos Biomedical Research, Inc, Frederick National Laboratory for Cancer Research, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
¹⁰ The Cancer Genome Atlas, Center for Cancer Genomics, Office of the Director, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
¹¹ Office of Health Technology 8, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
¹² Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.

PMID: 38867688
DOI: 10.1093/jnci/djae136

Abstract

The National Institutes of Health-US Food and Drug Administration Joint Leadership Council Next-Generation Sequencing and Radiomics Working Group was formed by the National Institutes of Health-Food and Drug Administration Joint Leadership Council to promote the development and validation of innovative next-generation sequencing tests, radiomic tools, and associated data analysis and interpretation enhanced by artificial intelligence and machine learning technologies. A 2-day workshop was held on September 29-30, 2021, to convene members of the scientific community to discuss how to overcome the "ground truth" gap that has frequently been acknowledged as 1 of the limiting factors impeding high-quality research, development, validation, and regulatory science in these fields. This report provides a summary of the resource gaps identified by the working group and attendees, highlights existing resources and the ways they can potentially be employed to accelerate growth in these fields, and presents opportunities to support next-generation sequencing and radiomic tool development and validation using technologies such as artificial intelligence and machine learning.

Publication types

Review

MeSH terms

Artificial Intelligence
High-Throughput Nucleotide Sequencing* / methods
Humans
Machine Learning
National Institutes of Health (U.S.)
Neoplasms / diagnostic imaging
Neoplasms / genetics
Radiomics
United States
United States Food and Drug Administration