{
  "abstract": "The use of a surrogate endpoint to replace a primary outcome relevant to patients in a clinical trial may allow faster approval of a novel treatment, but at the cost of increased uncertainty about treatment benefit. This risk may be amplified if the surrogate endpoint was inadequately or inappropriately evaluated against the patient relevant outcome. Many components of this evaluation currently lack consensus, including the most important non-statistical factors, the choice of statistical method, and whether numerical thresholds should be used. This paper presents a consensus based, multi-stakeholder framework (REASSurE: Recommendations for Evaluating A Single Surrogate Endpoint) containing a list of mandatory and recommended items for surrogate endpoint evaluation, with guidance on how to assess each item. Statisticians, trials methodologists, regulators, health technology assessment agencies, payers, and clinicians could use the REASSurE framework to achieve a holistic evaluation of a candidate surrogate endpoint, which is vital to ensure that the use of the surrogate endpoint is an appropriate decision.",
  "abstract_shown": true,
  "affiliations": [
    "Centre for Population Health Sciences, Usher Institute, School of Population Health Sciences, University of Edinburgh, Edinburgh, UK",
    "School of Medicine and Biomedical Sciences, Green Templeton College, University of Oxford, Oxford, UK",
    "Independent researcher, Columbia, MD, USA",
    "Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy",
    "Department of Thoracic Surgery, IEO, European Institute of Oncology IRCCS, Milan, Italy",
    "Biostatistics Research Group, Division of Public Health and Epidemiology, School of Medical Sciences, University of Leicester, Leicester, UK",
    "International Centre for Eye Health (ICEH), London School of Hygiene and Tropical Medicine, UK",
    "International Drug Development Institute, Louvain-La-Neuve, Belgium",
    "Centre for Research on Health and Social Care Management, SDA Bocconi, Milan 20136, Italy",
    "Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark",
    "Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark",
    "Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK",
    "Department of Experimental Oncology, IRCCS European Institute of Oncology, Milan, Italy",
    "Rheumatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt",
    "Fred Hutchinson Cancer Center, Seattle, WA, USA",
    "Office of New Drugs, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA",
    "Biostatistics Research Group, Newcastle University, UK",
    "Jasiri Cancer Research Foundation, Embu, Kenya",
    "St George Hospital and School of Population Health, University of New South Wales, Sydney, NSW, Australia",
    "SNTL Statistics Research and Consulting, London, UK",
    "Institute of Econometrics, Warsaw School of Economics (SGH), Warsaw, Poland",
    "Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol, Bristol, UK",
    "Interfaculty Initiative in Information Studies, The University of Tokyo, Tokyo, Japan",
    "Department of Biostatistics, University of Iowa, Iowa City, Iowa, USA",
    "Robertson Centre for Biostatistics & Primary Care and General Practice, School of Health and Wellbeing, University of Glasgow, Glasgow, UK",
    "Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud, Universidad San Ignacio de Loyola, Lima, Peru",
    "OBEMET Center for Obesity and Metabolic Health, Lima, Peru",
    "Edinburgh Clinical Trials Unit, Usher Institute, School of Population Health Sciences, University of Edinburgh, Edinburgh, UK"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 24,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Wang Pok Lo"
    },
    {
      "affs": [
        2
      ],
      "name": "Stuart G Baker"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Luca Bertolaccini"
    },
    {
      "affs": [
        5
      ],
      "name": "Sylwia Bujkiewicz"
    },
    {
      "affs": [
        6
      ],
      "name": "Catey Bunce"
    },
    {
      "affs": [
        7
      ],
      "name": "Marc Buyse"
    },
    {
      "affs": [
        8
      ],
      "name": "Oriana Ciani"
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    {
      "affs": [
        9,
        10
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      "name": "Robin Christensen"
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    {
      "affs": [
        11
      ],
      "name": "Jane Daniels"
    },
    {
      "affs": [
        12
      ],
      "name": "Sara Gandini"
    },
    {
      "affs": [
        13
      ],
      "name": "Tamer A Gheita"
    },
    {
      "affs": [
        14
      ],
      "name": "Peter B Gilbert"
    },
    {
      "affs": [
        15
      ],
      "name": "Laura Jaeger"
    },
    {
      "affs": [
        16,
        17
      ],
      "name": "Dorcas Kareithi"
    },
    {
      "affs": [
        18
      ],
      "name": "Marissa Lassere"
    },
    {
      "affs": [
        19,
        20
      ],
      "name": "Nicholas T Longford"
    },
    {
      "affs": [
        21
      ],
      "name": "Anthony M Manyara"
    },
    {
      "affs": [
        22
      ],
      "name": "Koji Oba"
    },
    {
      "affs": [
        23
      ],
      "name": "Emily K Roberts"
    },
    {
      "affs": [
        24
      ],
      "name": "Rod S Taylor"
    },
    {
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        25,
        26
      ],
      "name": "Carlos J Toro-Huamanchumo"
    },
    {
      "affs": [
        27
      ],
      "name": "Steff Lewis"
    },
    {
      "affs": [
        27
      ],
      "name": "Hannah Ensor"
    },
    {
      "affs": [
        27
      ],
      "name": "Christopher J Weir",
      "orcid": "0000-0002-6494-4903"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9qqf04vyws02r.bib",
  "cited_by": 0,
  "doi": "10.1136/bmj-2026-100618",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13714761/",
  "id": "9qqf04vyws02r",
  "issns": [
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  "landing_url": "https://doi.org/10.1136/bmj-2026-100618",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
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      "heading",
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      "2613|Statistical Methods in Clinical Trials"
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  "pdf_url": "https://www.bmj.com/content/bmj/394/bmj-2026-100618.full.pdf",
  "pmcid": "PMC13714761",
  "pmid": "42810755",
  "published": "2026-09-29",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/9qqf04vyws02r.ris",
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  "subjects": [
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      "field": "mathematics",
      "origin": "openalex:2613|Statistical Methods in Clinical Trials",
      "subfield": "statistics"
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  ],
  "title": "Recommendations for Evaluating A Single Surrogate Endpoint (REASSurE): Consensus-based surrogate evaluation framework with explanation and elaboration",
  "title_text": "Recommendations for Evaluating A Single Surrogate Endpoint (REASSurE): Consensus-based surrogate evaluation framework with explanation and elaboration",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:22:11Z",
  "url": "https://research.draconitic.com/paper/9qqf04vyws02r",
  "venue": "BMJ (Clinical research ed.)",
  "versions": []
}