Systemic Lupus Erythematosus (SLE) clinical trials have limitation reports on the limitations of clinical trials for lupus. Such limitations include:
- Strict eligibility criteria in an attempt to achieve standardization
- Poor recruitment
- Often early terminations
An investigative team from Manchester University Hospitals Hospitals NHS Foundation Trust sought to understand how accurately lupus nephritis (LN) clinical trials represented a real-world cohort, or group of people with the disease, by applying published trial eligibility criteria to people with LN participating in a large UK-wide registry.
In the study, investigators conducted a literature review of recent major published LN clinical trials and found that 50.6% of people in the group with active LN would not be eligible for clinical trial entry using published entry criteria. A problematic situation, this poses significant implications on the study of LN treatment in people with more severe disease.
The UK-based team recommends that when designing clinical trials, the stringency of eligibility criteria should be reviewed in order to provide greater representation of the target disease population.
The team is part of the Kellgren Centre for Rheumatology, NIHR Manchester Musculoskeletal Biomedical Research Centre, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom
Lupus Foundation of America
The Lupus Foundation of America was founded in 1977 as a national voluntary health organization based in Washington DC, with a network of chapters, offices and support groups located in communities throughout the United States. The Foundation is devoted to solving the mystery of lupus, one of the world’s cruelest, most unpredictable and devastating diseases while giving caring support to those who suffer from its brutal impact. Its mission is to improve the quality of life for all people affected by Lupus through programs of research, education, support, and advocacy.
A charitable organization with tax-exempt status granted under 501(C)(3) they are involved with fundraising and clinical research. In the past years, they have worked to secure $550 million in federal research funding and have allocated 400 grants and fellowship awards.
The foundation offers more information about clinical trials participation.Source: