Guest Commentary: Online Adjudication—The Next Frontier in EDC
Friday, June 12, 2009
By Linda Beneze, CEO of KIKA Clinical Solutions
One of the most exciting developments made possible by electronic data capture (EDC) is the process of adjudicating online.
Adjudication is the review of an event reported at a site by one or several experts in a clinical trial. It is performed to improve the reliability of assessments subject to interpretation.
Traditional adjudication is long and expensive. A project manager at a major sponsor explained, “When I used traditional adjudication in a late-stage trial, it took weeks to freeze the internal database. We sent a binder to each study member, and they had to complete their spreadsheets separately and send them back. Or, we tried to schedule in-person reviews.”
Until a few years ago adjudication often was omitted from the EDC workflow because it required features that were not available in existing platforms. Now, online adjudication offers full access to all data collected, providing a comprehensive review and enabling early detection of discrepancies. It accelerates the delivery of primary or secondary endpoints because it is a real-time process. Data collected are better quality, and there is a shorter time between event and adjudication.
Online adjudication also offers time, quality and cost improvement on large cohorts. There is no need to set up another system because it is fully integrated. It reduces the need for physical meetings and virtually eliminates shipping costs because documents and reports are online.
Combining EDC and online adjudication is a complete approach to clinical asset management. If a definition changes in the middle of a trial, a project manager can create an interim report quickly, and merge data into one table.
Online adjudication addresses new clinical challenges, including regulatory agencies requesting large-scale post-marketing surveillance programs.
KIKA Clinical Solutions
is a provider of advanced EDC solutions for pharmaceutical and medical device clinical trials. KIKA Clinical Solutions has made online adjudication a vital component of its web-based platforms, which have been successfully implemented in thousands of cases in oncology, cardiovascular, urology, radiology, neuroradiology and orthopedics.