Although advocates for lupus research have counted flawed clinical trial designs and a lack of biomarkers to predict drug response in trials as among the historical barriers to developing better therapies for the condition, they say findings from a study published last week in Lupus Science & Medicine™ provide an actionable framework to advance the lupus field.
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.
“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, of the Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. “Establishing global consensus among lupus patients and professionals is an essential first step toward 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, the biopharmaceutical industry, government, and patient advocacy through a collaborative effort led by the Lupus Foundation of America, researchers at the 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 and 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
- Lack of treatment adherence
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.
The ALPHA Project was launched in partnership with founding partner EMD Serono Research & Development, Inc. (a business of Merck KGaA in Darmstadt, Germany) and through additional support by GlaxoSmithKline.
Editor: Gary W. Cramer