Configuring Protocol Changes in Real Time for CTOT/CTOT-C

The Clinical Trials in Organ Transplantation (CTOT) and Clinical Trials in Organ Transplantation in Children (CTOT-C) projects are cooperative research programs sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and coordinated by Rho. CTOT and CTOT-C are investigative consortia for conducting clinical and associated mechanistic studies that will lead to improved outcomes for transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival. CTOT/CTOT-C trials are unique because they not only collect samples needed to analyze the safety and efficacy of a study treatment, but also to define new biomarkers and investigate the immunologic mechanisms related to organ transplantation.

Due to the cutting edge nature of their research, CTOT/CTOT-C protocols tended to change more often than average and the sample handling requirements were often more complex. Despite these challenges, the study team lead by Rho knew that accurate sample management was critical to the success of their clinical trials, so they adopted a custom sample tracking system to manage the collection, processing and shipment of their mechanistic specimens. This traditional Specimen Tracking Software (STS) worked well, but each new clinical trial required the help of an experienced programmer to configure, taking 2-3 months to implement and test. In addition, the software required the installation of an applet on the computer to be used, which often required the clinical sites and labs to enlist the assistance of their local IT department, causing further delays to study start. It became clear that in order to keep up with their rate of growth, the team would need a system that could overcome these limitations.

Their solution: partner with Sampleminded to create a non-traditional STS that would allow changes to be configured quickly and easily and would lower overall operating costs.

In collaboration with Rho, Sampleminded designed a sample management system that supported real-time updates and easy versioning of specimen collection requirements. The Sampleminded Clinical Research system also included a user-friendly interface (Study Builder) that enabled non-programmers, such as clinical research analysts or project managers, to easily configure all facets of a clinical trial, including visit collection requirements, kit definitions, and security access. Using Study Builder, the study team would now be able to configure a new trial in a matter of days.

When it was time to launch, the Sampleminded team worked closely with Rho to migrate all of their existing data to the new Sampleminded system, resulting in minimal system downtime and maximum continuity for their existing users. Users were able to process samples the day before launch, and pick up where they left off in Sampleminded the next morning. Because Sampleminded was deployed to the cloud as a Software as a Service (SaaS) solution, Rho was spared the time and expense previously needed to backup databases, monitor security, and maintain servers in house.

Due to the cost and time savings, Rho was able to scale to over 150 users, 16 studies and 64 sites, with management of over 275,000 specimens in 2015. Today, Rho continues to track samples from 12 active clinical trials worldwide through the Sampleminded system.

“Sampleminded partnered with us to ensure their solution would be both intuitive and flexible,” said David Ikle, Ph.D., Senior Statistical Scientist, Rho. “ By using the Sampleminded application, we have not only saved over $200K in hosting and development costs, but our tracking and sample management issues are now almost negligible. The automated shipment alerts virtually eliminates communication gaps with the labs and we have a much faster turn-around time for getting a new trial up and running.”