Developing a web-based central laboratory shipment scheduler and information system
05/2017
Presentation
Authors:
Daniels, Kayla;
Frasketi, Michael;
Shmueli-Blumberg, Dikla;
Dawson, Peter
Secondary:
SCT Annual Meeting
Location: Liverpool, UK
URL:
https://sctweb.org/presentations/
Keywords:
Information Systems & Technology Data Management Trial Management & Research Coordination
Abstract:
The use of central laboratories in multi-site clinical trials is common to ensure consistency in reporting and analysis of assay results. The additional time between sample collection and analysis is typically not a burden for frozen or otherwise properly stored specimens. When assay results are time sensitive due either to the sample type (e.g. fresh cells) or need for immediate results, local laboratories are often utilized. If an assay is novel or proprietary, however, the local laboratory may not be able to perform the assay and a specific central or research laboratory must be utilized. In several recent multicenter studies, an assay required shipment of whole blood samples and immediate labor intensive processing by a specific central laboratory. Despite extensive piloting to reduce time from collection to analysis and obtain quality assay results, an unexpected predicament developed during the trial in which sites were shipping more specimens than the lab could successfully test in a timely fashion due to limited central laboratory resources; resulting in failed assays. The coordinating center for these studies had to find an immediate solution that was convenient and accessible to both central laboratory and site staff. In response, coordinating center staff developed and deployed an access controlled shipment scheduler web site to allow sites and lab staff to more efficiently coordinate. Clinical site users entered shipment details and a validation routine capped each site at a certain number and type of clinical sample shipments. Central laboratory users could then monitor when specimens would be shipped to them and indicate lab closures or other dates shipments could not be accepted, thereby allowing better allocation of lab staff resources. Addition of the shipment scheduler to the laboratory management process resolved the difficulties involving laboratory capacity and the studies were able to continue obtaining novel, high quality assay results. This presentation will highlight some of the infrastructure and functionality of the system that may be relevant and applicable for studies with existing laboratory management systems or those interested in creating such a process. Furthermore, we will discuss the importance of flexibility among the clinical trial management team and the value of adapting processes to correspond with constantly changing requirements of a research trial.
