International Lupus Community Reaches First-Ever Agreement on Barriers to Research, Drug Development, Care and Access


Findings from a study published  in Lupus Science & Medicine™ provide an actionable framework to advance the lupus field, which has seen many failed clinical trials, variations in care and poor access to care worldwide. The study, “Global Consensus Building and Prioritization of Fundamental Lupus Challenges: The ALPHA Project ,” brought together experts across 20 countries to provide the first-ever global consensus on key issues in lupus, which until they are addressed, will continue to be major barriers in lupus diagnosis, care and treatment development.

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“This research effort is momentous for the international lupus community; one that has never before been brought together for an initiative to address the most critical issues facing the field,” said principal investigator Kenneth A. Getz, MBA, Center for the Study of Drug Development at Tufts University School of Medicine. “Establishing global consensus among lupus patients and professionals is an essential first step towards creating a clear and focused path forward for more timely and accurate diagnosis, greater access to care and improved treatment options for people living with lupus.”

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project conducted interviews with and surveyed lupus thought leaders in research, clinical practice, biopharmaceutical industry, government and patient advocacy, through a collaborative effort led by the Lupus Foundation of America, researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and a Global Advisory Committee of 13 lupus experts representing industry, academia and the patient voice.

The study validated known challenges in lupus, identifying lupus heterogeneity as the primary barrier impeding drug development, clinical care and access. Additionally, experts agreed upon the five top barriers to improving outcomes in lupus:

  • Lack of diagnostic, predictive and prognostic biomarkers for lupus and lack of biomarkers to predict drug response in clinical trials;
  • Flawed clinical trial design;
  • Lack of access to clinicians familiar with lupus/limited awareness of lupus among non-expert medical professionals;
  • Barriers to effective management of lupus due to social determinants of care in predominantly lower socioeconomic status areas;
  • And, lack of treatment adherence.

“This is an exciting time for the international lupus community,” said Stevan W. Gibson, president and CEO, Lupus Foundation of America. “The Lupus Foundation of America is proud to lead this first-of-its-kind global project to begin tackling the crisis in the lupus field created by long-standing barriers. These study findings further support our commitment towards building consensus on the priorities in lupus across communities and continents, ultimately to develop solutions for those living with lupus around the world.”

The next step of the ALPHA Project will be to assemble the Global Advisory Committee and other lupus stakeholders to develop and implement a road map of specific solutions to address each barrier identified through this research. To learn more, visit

Survey methodology

A global online survey was distributed to 366 candidates and 127 (35%) completed responses were received from individuals across the globe. The GAC, LFA, and Tufts CSDD closely collaborated to develop the survey, which was informed by 17 in-depth interviews with lupus patients and professionals.


The ALPHA Project was launched in partnership with founding partner EMD Serono Research & Development, Inc. (a business of Merck KGaA, Darmstadt, Germany) and through additional support by GlaxoSmithKline.


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