{
  "abstract": "Background/Objectives: Metabolomics has the potential to enhance the definition of medication response phenotypes in early-phase clinical trials, yet global uptake and distribution are not well characterised. This study provides an international assessment of metabolomics integration in registered early-phase clinical trials. Methods: Data were obtained from the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). Early-phase trials (phase 0–II) conducted from 2010 to 2025 were analysed, and metabolomics studies were identified using predefined keyword searches across trial records. Results: A total of 183,041 early-phase trials were identified, of which 640 (0.35%) incorporated metabolomics. Uptake has increased modestly over time but remains low overall and is concentrated predominantly in high-income countries. The United Kingdom demonstrated the highest proportional integration (1.3%), while the People’s Republic of China (n = 237) and the United States of America (n = 90) contributed the greatest absolute number of trials with metabolomics. Among the included metabolomic studies: 187 (29.2%) were phase 0, 229 (35.8%) were phase I trials, 183 (28.6%) were phase II, and 41 (6.4%) were combined phase I/II studies. Metabolomics was most commonly included as a secondary, rather than primary outcome (49.7% vs. 25.3%). Conclusions: Metabolomics remains underutilised in early-phase clinical trials. Addressing barriers to implementation will be critical to enable broader integration of metabolomics into early-phase clinical trials and to integrate a multi-omic approach to precision medicine.",
  "abstract_shown": true,
  "affiliations": [
    "William Harvey Research Institute, Queen Mary University of London, London EC1M 6BQ, UK",
    "Department of HIV Medicine, Chelsea and Westminster Hospital, London SW10 9NH, UK",
    "Department of Infectious Disease, Imperial College London, London SW7 2AZ, UK"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 5,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Jack T. Thompson"
    },
    {
      "affs": [
        0
      ],
      "name": "Maia Megase",
      "orcid": "0009-0004-4797-9794"
    },
    {
      "affs": [
        1,
        2
      ],
      "name": "Marta Boffito"
    },
    {
      "affs": [
        0
      ],
      "name": "Mark J. Caulfield",
      "orcid": "0000-0001-9295-3594"
    },
    {
      "affs": [
        0
      ],
      "name": "Emma F. Magavern"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/6xa3t6ez49vg7.bib",
  "cited_by": 0,
  "doi": "10.3390/metabo16100777",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13707337/?tool=EBI",
  "id": "6xa3t6ez49vg7",
  "issns": [
    "2218-1989"
  ],
  "landing_url": "https://www.mdpi.com/2218-1989/16/10/777",
  "language": "eng",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "1312|Metabolomics and Mass Spectrometry Studies"
    ]
  ],
  "openalex": "W7221808916",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13707337/pdf/?tool=EBI",
  "pmcid": "PMC13707337",
  "pmid": null,
  "published": "2026-10-01",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/6xa3t6ez49vg7.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:00Z",
      "native_id": "10.3390/metabo16100777",
      "source": "crossref",
      "url": "https://www.mdpi.com/2218-1989/16/10/777"
    },
    {
      "first_seen": "2026-10-30T12:21:47Z",
      "native_id": "PMC:PMC13707337",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13707337"
    }
  ],
  "subjects": [
    {
      "field": "biochemistry",
      "origin": "openalex:1312|Metabolomics and Mass Spectrometry Studies",
      "subfield": "molecular-biology"
    }
  ],
  "title": "Metabolomics in Early-Phase Clinical Trials from 2010 to 2025",
  "title_text": "Metabolomics in Early-Phase Clinical Trials from 2010 to 2025",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:21:47Z",
  "url": "https://research.draconitic.com/paper/6xa3t6ez49vg7",
  "venue": "Metabolites",
  "versions": []
}