Systemic Lupus Erythematosus (SLE) clinical trials have limitations, including stringent eligibility criteria in an attempt to achieve standardization. Strict eligibility criteria leads to poor recruitment, which can lead to early termination of a trial. As such, clinical trials may not reflect the disease population of interest and outcomes can be difficult to generalize.
Investigators explored 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.
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A literature review of recent major published LN clinical trials found that 50.6% of people in the group with active LN would not be eligible for clinical trial entry using published entry criteria. This poses significant implications on the study of LN treatment in people with more severe disease.
The researchers recommend that when designing clinical trials, the stringency of eligibility criteria should be reviewed in order to provide greater representation of the target disease population. Learn about participating in clinical trials.
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