Despite a history riddled with setbacks, lupus researchers may now be able to construct more effective clinical trials following the published results of a collaboration in drug product development, the Lupus Foundation of America said in a recent release.
Lupus researchers have long encountered challenges in developing effective treatment for the disease, such as when control groups administered placebos inexplicably showed more improvement than their treated counterparts, complicating the ability to assess the effectiveness or safety of new approaches.
In 2009, the Lupus Foundation of America established the LFA Collective Data Analysis Initiative (LFA CDAI), a first-time collaboration among companies to improve clinical trials for the benefit of lupus patients.
In its latest findings, LFA found that relatively short phase 2 clinical trials may not have significant bearings on outcomes for longer clinical trials, the release said. In addition, scientists discovered that varying response rates are dependent on not only the severity of the disease in individuals but also the efficacy of background immune-suppressive medications.
“The results from this study can be used by the lupus clinical trials community to improve the design of future studies and to accelerate the identification of effective new therapies that would ultimately benefit everyone who suffers from lupus,” LFA said in the release.