Lupus Clinical Trials Omit Many People from Participating Due to Restrictive Eligibility Criteria

New data show a large percentage of people with moderate to severe lupus are unable to take part in clinical research trials due to restrictive eligibility criteria – characteristics that must be shared by all participants in order to be included in a study. In a national register of people with moderate to severe lupus, most (63%) would not be able to participate in phase III lupus trials because they did not meet eligibility criteria. And, nearly half (43%) of those with active lupus nephritis (LN) would not be able to participate in phase III LN trials.

Phase III trials are late-stage studies in which researchers can investigate the safety and effectiveness of a treatment in a large group of people. It’s also often the final step before advancing a drug for federal approval.

The most common reasons for exclusion in non-LN lupus trials were active kidney involvement and low disease activity. Overall, people with multiple co-occurring illnesses were less likely to be eligible to participate in non-LN lupus trials. In LN trials, the most common reason for exclusion was preexisting impaired kidney function.

Clinical research trials are critically important to developing and approving new treatments for lupus. However, many studies are forced to end prematurely due to a lack of sufficient participation. The latest findings suggest that study eligibility criteria may be too restrictive, and for that reason, phase III clinical trials also may not be generalizable to the real-world lupus population.

Raising awareness of opportunities to participate in clinical trials in under-represented populations is important. The researchers noted The Lupus Foundation of America's (LFA’s) ongoing work in this area. LFA recognizes that participation in lupus studies from ethnic minority groups is low, resulting in a lack of data on the effectiveness and safety of treatments in those who have the greatest lupus health risks. Learn about getting involved in lupus research.

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