Too Many Lupus Patients Precluded from Clinical Trials Due to Overly Complex Inclusion Criteria

Too Many Lupus Patients are Being Precluded from Lupus Clinical Trials Due to Overly Complex Inclusion Criteria

Much like in the therapeutic area of oncology, where overly stringent study protocol inclusion and exclusion criteria make it very difficult for large numbers of people to qualify and thus participate in the study, the same trend is occurring among lupus patients. New study data indicate that perhaps a majority of patients with moderate to severe lupus cannot participate in clinical research, even if a particular clinical trial could extend or save a life. In a nutshell, 63% of members in a national moderate-to-severe lupus organization couldn’t participate in Phase 3 lupus clinical trials for failure to meet inclusion criteria. Moreover, 43% of the patient population with active lupus nephritis (LN) is not eligible due to the standard onerous inclusion criteria promulgated in most studies today.

A Mission-Critical Problem Across Therapeutic Areas

As nicely articulated by the Lupus Foundation 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. For...

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