PT  - JOURNAL ARTICLE
AU  - Joy Buie
AU  - Lauren Bloch
AU  - Eric F Morand
AU  - Ronald F van Vollenhoven
AU  - Victoria P Werth
AU  - Zahi Touma
AU  - Peter Lipsky
AU  - Kenneth Kalunian
AU  - Anca D Askanase
AU  - L Ines
AU  - Christopher Reed
AU  - MaryBeth Son
AU  - Timothy Franson
AU  - Karen Costenbader
AU  - Laura Eve Schanberg
TI  - Meeting report: the ALPHA project: a stakeholder meeting on lupus clinical trial outcome measures and the patient perspective
AID  - 10.1136/lupus-2023-000901
DP  - 2023 Feb 01
TA  - Lupus Science & Medicine
PG  - e000901
VI  - 10
IP  - 1
4099  - http://lupus.bmj.com/content/10/1/e000901.short
4100  - http://lupus.bmj.com/content/10/1/e000901.full
SO  - Lupus Sci Med2023 Feb 01; 10
AB  - 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.