Figurski, Michal J.;
Berlas, Shaila;
Korecka, Magdalena;
Foroud, Tatiana M.;
Galasko, Doug R.;
Shaw, Leslie M.
Web‐based requisitioning, tracking and laboratory result reporting system for clinical trials using a central laboratory : Biomarkers (non‐neuroimaging)/Use in clinical trial design and evaluation
: Biomarkers (non‐neuroimaging)/Use in clinical trial design and evaluation
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Medientyp:
E-Artikel
Titel:
Web‐based requisitioning, tracking and laboratory result reporting system for clinical trials using a central laboratory : Biomarkers (non‐neuroimaging)/Use in clinical trial design and evaluation
:
Biomarkers (non‐neuroimaging)/Use in clinical trial design and evaluation
Beteiligte:
Figurski, Michal J.;
Berlas, Shaila;
Korecka, Magdalena;
Foroud, Tatiana M.;
Galasko, Doug R.;
Shaw, Leslie M.
Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Chemical biomarkers are increasingly important in clinical trials. Many multi‐center trials use single core laboratory to process biomarkers, to ensure comparability of results. Sample shipment is accompanied by transmission of data between centers, core lab, and other entities. Often physical forms are used: transmitted via email, fax, or as paper forms. Consequently, flow of information about samples is restricted. Core laboratories receive inquiries about sample receipt on a daily basis. The process of information look‐up is a substantial burden on the lab personnel, more so when paper forms are involved, and especially when samples were not actually received.</jats:p></jats:sec><jats:sec><jats:title>Method</jats:title><jats:p>To alleviate the issues that arise in this setting, we created a secure web‐based system that integrates information about sample, shipment and test results. The application (“R3+ system” for Requisitioning, Tracking and Result Reporting) allows participating centers to enter information about samples being shipped (Requisitioning), track shipment and the progress of the sample as it’s received and analysed by the core laboratory (Tracking), and see results of analyses, along with full Audit Trail and automated timestamping of all steps (Result Reporting). Records, both current and past, can be retrieved at any time.</jats:p></jats:sec><jats:sec><jats:title>Result</jats:title><jats:p>The first project using the application is BioSTAC: a multi‐center trial evaluating biomarkers Abeta42, Tau and p‐Tau, in CSF samples shipped overnight at ambient temperature. Participating centers received no training in using R3+ except instruction on registering an account. Within the first 2 months of operation, 14 users from 11 centers registered their accounts. 24 samples have been requested and reported via this application to 6 centers. No usability or security issues were reported. BioSTAC users have requested to utilize the app in other projects, thus two other projects are now actively using this platform.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Implementation of the web‐based system for storage and transmission of data about the samples in clinical trials has proven to be easy to use and an efficient means of communication, as it replaces email, fax and paper forms, and eliminates the need for querying paper records. Users typically report high satisfaction using this system, while core laboratory personnel save time on administrative tasks.</jats:p></jats:sec>