LFA Research Improving Clinical Trial Design

Researchers face multiple obstacles that can hinder their ability to show whether a potential lupus treatment works or may be better than a current treatment. Years of disappointing results in lupus drug development demonstrates that a different approach is needed.

In 2009, the Lupus Foundation of America established the LFA Collective Data Analysis Initiative (LFA CDAI), a first-in-lupus collaboration among multiple companies with a shared goal – to improve clinical trials so we can have an arsenal of treatments needed for people living with lupus.

Since its inception, LFA CDAI has published important findings on the impact of background medications taken by people with lupus during clinical trials. The latest LFA CDAI analysis builds upon this work.

In this study, researchers looked at the long-term effects of a potential treatment on health outcomes. The results showed that shorter Phase 2 clinical trials may not be effective at predicting outcomes in longer clinical trials.

Researchers also found that response rates to the standard of care treatment are affected by the severity of the disease and the aggressiveness of background immuno-suppressive treatments, which has implications for the selection of participants in future clinical trials.

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.

We are aggressively working to accelerate the search for cures, but we must first improve and streamline clinical trials.

In an earlier CDAI study, researchers found that the use of many different kinds of background medications in lupus trials results in high response rates among placebo groups. This makes it challenging to evaluate new treatments that might be safer or more effective.

The analysis includes some insights that can help people who design clinical trials come up with ways to improve study designs, in order to be able to see whether an investigational treatment has advantages over current options.

These studies will help the lupus research community conduct stronger clinical trials that produce more meaningful data, which will accelerate the development of new therapies.

For more information on Foundation research priorities, visit lupus.org/research.