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

Publication ,  Journal Article
Buie, J; Bloch, L; Morand, EF; van Vollenhoven, RF; Werth, VP; Touma, Z; Lipsky, P; Kalunian, K; Askanase, AD; Ines, L; Reed, C; Son, M ...
Published in: Lupus Sci Med
February 2023

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.

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Published In

Lupus Sci Med

DOI

ISSN

2053-8790

Publication Date

February 2023

Volume

10

Issue

1

Location

England

Related Subject Headings

  • Research Design
  • Prospective Studies
  • Patient Reported Outcome Measures
  • Outcome Assessment, Health Care
  • Lupus Erythematosus, Systemic
  • Humans
  • 3204 Immunology
  • 3202 Clinical sciences
 

Citation

APA
Chicago
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MLA
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Buie, J., Bloch, L., Morand, E. F., van Vollenhoven, R. F., Werth, V. P., Touma, Z., … Schanberg, L. E. (2023). Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective. Lupus Sci Med, 10(1). https://doi.org/10.1136/lupus-2023-000901
Buie, Joy, Lauren Bloch, Eric F. Morand, Ronald F. van Vollenhoven, Victoria P. Werth, Zahi Touma, Peter Lipsky, et al. “Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective.Lupus Sci Med 10, no. 1 (February 2023). https://doi.org/10.1136/lupus-2023-000901.
Buie J, Bloch L, Morand EF, van Vollenhoven RF, Werth VP, Touma Z, et al. Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective. Lupus Sci Med. 2023 Feb;10(1).
Buie, Joy, et al. “Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective.Lupus Sci Med, vol. 10, no. 1, Feb. 2023. Pubmed, doi:10.1136/lupus-2023-000901.
Buie J, Bloch L, Morand EF, van Vollenhoven RF, Werth VP, Touma Z, Lipsky P, Kalunian K, Askanase AD, Ines L, Reed C, Son M, Franson T, Costenbader K, Schanberg LE. Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective. Lupus Sci Med. 2023 Feb;10(1).

Published In

Lupus Sci Med

DOI

ISSN

2053-8790

Publication Date

February 2023

Volume

10

Issue

1

Location

England

Related Subject Headings

  • Research Design
  • Prospective Studies
  • Patient Reported Outcome Measures
  • Outcome Assessment, Health Care
  • Lupus Erythematosus, Systemic
  • Humans
  • 3204 Immunology
  • 3202 Clinical sciences