For sponsors and CROs, clinical trials for systemic lupus erythematosus (SLE or, more commonly, lupus) present a specific set of challenges that can impact the recruitment of investigators and patients and inhibit the ability to collect accurate data.
In 2017, a global CRO headquartered in Durham, North Carolina, learned about Clinical Ink’s technical capabilities and its success in remotely monitoring and capturing data for recent Ebola clinical trials. Its lupus clinical research team saw an opportunity to re-create this success and improve the way lupus clinical trials are conducted. Upon recognizing this, the companies formed a partnership. As a result, Clinical Ink developed a technology platform called the electronic Lupus Disease Assessment Suite (eLAS™) to improve and streamline the way data is collected for this specific therapeutic area. The launch of eLAS helped study teams drive protocol compliance and capture source data at the time of the patient visit, which improved data quality and integrity.
The CRO partnership allowed eLAS to be successfully tested, perfected, and adapted for use in multiple lupus clinical trials. The efficiencies created are significant to the future of lupus treatment. By providing better data sooner, eLAS can help sponsors and study teams make better-informed study decisions earlier, potentially saving significant costs and time. This, in turn, may encourage more lupus research. And not only is this platform potentially transformational for lupus research but it holds significant promise to be adapted for use in other therapeutic areas.
This white paper discusses the challenges of diagnosing lupus, the unique difficulties lupus clinical trials face, and how the innovative eLAS platform helps meet these challenges.