Study of latest in clinical data technology applied to Phase II clinical trial in South Africa

Last week, at the fourth annual Clinical Trials in Emerging Economies conference, Margaret Ann Snowden, Director of Biostatistics and Data Management at Aeras Global TB Vaccine Foundation, and Daragh Ryan of Cmed Technology, presented a case study of the application of the latest in clinical data technology to a large Phase II clinical trial in South Africa. The presentation provided an update on how effective technology can be in promoting the development of affordable vaccine regimens for the prevention of tuberculosis (TB) worldwide.

In July 2009, Aeras enrolled the first subjects in a Phase II double-blind, randomized clinical trial of a TB vaccine candidate in infants in Worcester, South Africa. In this study, Aeras is using Cmed's Timaeus clinical data management platform to electronically capture data from three clinical sites in South Africa, while managing and analyzing the data from its headquarters in Rockville, Maryland USA in near real time. The Timaeus self-contained appliance technology allows clinicians and study coordinators in South Africa to capture data and perform edit checks on clinical data immediately; per study metrics to date, edit checks take an average of 0.376 seconds to run, and page turn rate has averaged 0.119 seconds. Timaeus then communicates all captured data to Aeras' US headquarters using consumer-standard, off-the-shelf mobile data cards, enabling staff at Aeras to review or report upon clinical data upon transmission.

"Aeras is an agile organization. We want the ability to make real-time, metric-based decisions on a weekly – and even daily – basis, as needed, and to position ourselves to be submission-ready on the back end," said Snowden.

When asked about the sites' experience with Timaeus over the past year, Snowden indicated that Aeras had received very positive feedback to date. In total, only 12 user calls have been placed to Cmed Technology's help desk. To prevent staff downtime, Timaeus will continue to work in the event no mobile signal is present, similar to industry-leading mobile devices. Clinicians and monitors can continue to work without interruption. When the mobile signal is restored, Timaeus automatically re-connects and communicates all data (with a full audit trail) without any user action.  

As Aeras expands its global vaccine development, Cmed Technology will continue its partnership with Aeras for ongoing advancement in the areas of trial configuration, monitoring, data management and reporting.

SOURCE Cmed Technology