Evidence map›Paper›PMID 37537705›Full record

ArticleLupus science & medicine2023

Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective.

Joy Buie, Lauren Bloch, Eric F Morand, Ronald F van Vollenhoven, Victoria P Werth, Zahi Touma, Peter Lipsky, Kenneth Kalunian, Anca D Askanase, L Ines and 5 more

Abstract read
In one paragraph

Article in Lupus science & medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Joy BuieResearch, Lupus Foundation of America, Washington, District of Columbia, USA buie@lupus.org.ORCID 0000-0003-4026-4812
Lauren BlochHealth Policy and Regulatory Affairs, Faegre Drinker Biddle and Reath LLP Washington, Washington, District of Columbia, USA.
Eric F MorandRheumatology, Monash Medical Centre, Melbourne, Victoria, Australia.ORCID 0000-0002-9507-3338
Ronald F van VollenhovenDepartment of Rheumatology and Clinical Immunology, Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, The Netherlands.ORCID 0000-0001-6438-8663
Victoria P WerthDermatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.ORCID 0000-0003-3030-5369
Zahi ToumaDivision of Rheumatology, Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, Ontario, Canada.ORCID 0000-0001-5177-2076
Peter LipskyRILITE Research Institute, Charlottesville, Virginia, USA.
Kenneth KalunianDepartment of Medicine, UCSD, La Jolla, California, USA.
Anca D AskanaseMedicine, Columbia University College of Physicians and Surgeons, New York, New York, USA.ORCID 0000-0003-4597-5023
L InesFaculty of Health Sciences, Univ Beira Interior, Covilha, Portugal.ORCID 0000-0003-3172-3570
Christopher ReedReed Consulting, LLC, Atlanta, Georgia, USA.
MaryBeth SonDivision of Immunology, Boston Children's Hospital, Boston, Massachusetts, USA.ORCID 0000-0002-7394-2862
Timothy FransonFaegre Drinker Consulting, Indianapolis, Indiana, USA.
Karen CostenbaderMedicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Laura Eve SchanbergPediatrics, Duke University, Durham, North Carolina, USA.ORCID 0000-0002-1913-6472

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Drug development in lupus has improved over the past 10 years but still lags behind that of other rheumatic disease areas. Assessment of prospective lupus therapies in clinical trials has proved challenging for reasons that are multifactorial including the heterogeneity of the disease, study design limitations and a lack of validated biomarkers which greatly impacts regulatory decision-making. Moreover, most composite outcome measures currently used in trials do not include patient-reported outcomes. Given these factors, the Addressing Lupus Pillars for Health Advancement Global Advisory Committee members who serve on the drug development team identified an opportunity to convene a meeting to facilitate information sharing on completed and existing outcome measure development efforts. This meeting report highlights information presented during the meeting as well as a discussion on how the lupus community may work together with regulatory agencies to simplify and standardise outcome measures to accelerate development of lupus therapeutics.

Indexed as

Lupus Erythematosus, SystemicHumansOutcome Assessment, Health CarePatient Reported Outcome MeasuresProspective StudiesResearch Designclinical triallupus erythematosus, systemiclupus nephritisoutcome assessment, health care

Identifiers

PMID37537705
PMCPMC9930541

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.