A New Approach To Collecting Assessments In Lupus Trials: Software Improves Data Quality And Speeds Data Review

By Rinah Yamamoto and Doug Pierce

Systemic Lupus Erythematosus (SLE) is a complex disease that is difficult both to diagnose and to track through the array of symptoms and periods of flares and remissions that patients experience. Multiple clinical outcomes assessments (COA) are typically used to confirm endpoints in clinical trials of SLE treatments, and the evaluation and scoring process is time-consuming for investigators. Overlaps between the profiles in the various assessments can lead to inconsistencies in reporting. Errors can also creep in because clinicians typically complete the assessments after the patient has left the site, relying on notes taken during the visit. Data reliability is further reduced because the data are transcribed multiple times into different assessments and systems. Unsurprisingly, the process generates a high volume of queries that can take weeks to investigate and resolve – often requiring source data verification.

Technology offers a solution. The various assessments can be integrated into one automated tool for investigators to use during the patient visit. An application that guides the clinician through the clinical lupus assessments following the structure and flow of the patient visit can automatically display critical information from one visit to the next, allowing electronic forms to be completed in the presence of the patient. The result is cleaner data, fewer queries, real-time data review, and shortened study timelines.