{
  "abstract": "The Lupus Research Alliance formed the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) in 2023 as a public-private partnership with investigators, pharmaceutical companies, the Food and Drug Administration, National Institutes of Health, patient-focused non-profits and professional societies with the goals of developing initiatives to accelerate lupus drug development in a precompetitive setting, and ensuring that perspectives of people with lived experience of lupus are included into the drug development process. Patient-reported outcome (PRO) measures are a top area of focus for the Lupus ABC. To support future work in the area of PROs, a public meeting was held on 16–17 October 2024 with the objectives of (1) assessing the current state of PROs used in lupus clinical trials, (2) developing a roadmap to advance the use of PROs in lupus clinical trials and (3) identifying and setting priorities for efforts to be pursued by a Lupus ABC PRO Working Group. After a series of presentations, small groups addressed what PRO domains to measure, the questionnaire burden for trial participants, how PROs should be selected for trials and what efforts are needed to advance use of PROs in lupus clinical trials.Meeting participants concluded that although PROs are being collected in most lupus clinical trials, they may be underused as primary or secondary/exploratory endpoints. A strong desire to change the focus in trials from disease activity and signs to include PROs, as a way of highlighting patients’ voices, was noted. The group concluded that the specific steps needed are to identify PRO measures appropriate for the target populations of interest, incorporate PROs into endpoints for regulatory decision-making, ensure PRO data are publicly available and accessible to researchers and involve people living with lupus in selection of PRO domains, measures and trial design. For these actions, collaborations among industry, researchers, regulators, payors and patients are needed.",
  "authors": [
    {
      "affiliations": [
        "Medicine, University of California San Francisco, San Francisco, California, USA"
      ],
      "name": "Patricia Katz"
    },
    {
      "affiliations": [
        "Columbia University Irving Medical Center, New York City, New York, USA"
      ],
      "name": "Anca D Askanase"
    },
    {
      "affiliations": [
        "Person living with lupus, New York City, New York, USA"
      ],
      "name": "Nandan Baruah"
    },
    {
      "affiliations": [
        "AstraZeneca, Gaithersburg, Maryland, USA"
      ],
      "name": "Wen-Hung Chen"
    },
    {
      "affiliations": [
        "Person living with lupus, New York City, New York, USA"
      ],
      "name": "Anna Fisch"
    },
    {
      "affiliations": [
        "Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA"
      ],
      "name": "Lili Garrard"
    },
    {
      "affiliations": [
        "Medicine, Rush University Medical Center, Chicago, Illinois, USA"
      ],
      "name": "Meenakshi Jolly"
    },
    {
      "affiliations": [
        "Person living with lupus, New York City, New York, USA"
      ],
      "name": "Veronica Vargas Lupo"
    },
    {
      "affiliations": [
        "Person living with lupus, Montclair, New Jersey, USA"
      ],
      "name": "Judith Mills"
    },
    {
      "affiliations": [
        "AbbVie, Gaithersburg, Maryland, USA"
      ],
      "name": "Elektra Papadopoulos"
    },
    {
      "affiliations": [
        "EMD Serono, Rockland, Massachusetts, USA"
      ],
      "name": "Josephine Park"
    },
    {
      "affiliations": [
        "Division of Rheumatology, Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Ontario, Canada",
        "Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Zahi Touma"
    },
    {
      "affiliations": [
        "Lupus Research Alliance, New York City, New York, USA"
      ],
      "name": "Nicole Cooper"
    },
    {
      "affiliations": [
        "Lupus Research Alliance, New York City, New York, USA"
      ],
      "name": "Carla Menezes"
    },
    {
      "affiliations": [
        "Lupus Research Alliance, New York City, New York, USA"
      ],
      "name": "Teodora P Staeva"
    },
    {
      "affiliations": [
        "Lupus Research Alliance, New York City, New York, USA"
      ],
      "name": "Hoang Nguyen"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Tampa, Florida, USA"
      ],
      "name": "Cindy Coney"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Central Islip, New York, USA"
      ],
      "name": "Jeanine Cox"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Hinsdale, Illinois, USA"
      ],
      "name": "Carrie Eberspecher"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Brooklyn, New York, USA"
      ],
      "name": "Shanelle Gabriel"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Topanga, California, USA"
      ],
      "name": "Shane Lerner"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, New York City, New York, USA"
      ],
      "name": "Malinda Logan"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, San Antonio, Texas, USA"
      ],
      "name": "Erika Reyna"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Kearney, New Jersey, USA"
      ],
      "name": "Elizabeth Santa Cruz"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Los Angeles, California, USA"
      ],
      "name": "Brian Ung"
    },
    {
      "affiliations": [
        "Lupus Voices Council of Lupus ABC, Garrison, New York, USA"
      ],
      "name": "Narae Yun"
    },
    {
      "affiliations": [],
      "name": "Lupus Voices Council of Lupus ABC"
    }
  ],
  "title": "New efforts to incorporate patient-reported outcomes into lupus clinical trials: report of the community meeting convened by the Lupus Accelerating Breakthroughs Consortium (Lupus ABC), 16–17 October 2024",
  "uid": "d332ec61-b3fc-5b8b-af2c-de525086a6b2"
}