Resources
Case Study: Glassbox
Client
Translational Genomics Research Institute (TGen)
Industry
Life Sciences
Overview
TGen envisioned a research study where they would prepare a series of 3-4 composite tissue microarray (TMA) blocks by requesting 3 clinically annotated, properly consented brain tumor specimens from at least 15 institutes around the world. Once the tumors were sent and organized into the blocks, slides from the blocks representing 45 tumors would be cut and distributed back to collaborators with unique immunohistochemistry (IHC) expertise to evaluate the expression of candidate markers on the tissue section. All results would be made available to the collaborators for testing hypotheses related to specific molecular markers and glioma behavior (proliferation, progression, invasion, survival, patterns of recurrence, location of recurrence, etc.). The end goal was to sharpen, accelerate and refine the use of multi-institutional specimen collections to develop new diagnostic markers, prognostic leads and therapeutic targets for brain cancer and serve as a model for future collaborative studies. TGen needed a way to connect international researchers, direct and share clinical, lab, and genomic research data, while at the same time protecting the privacy of individuals and access to the data at very discrete levels.
Problem
Orchestrating the logistics and information technology just in terms of subjects, researchers, and specimens represented a significant hurdle. The clinical research industry lacks an affordable mechanism, despite the fact that thousands of investigator initiated studies are run each year. Particularly painful was the idea that all data submitted would have to be reassembled by hand at TGen. The global distribution of the collaborators - from the U.S., Europe and Asia - prevented the integration of each institution’s system due to overall expense and time. Adding to the complexity was the requirement to connect each tumor specimens’ clinical data with the block and slide creation, as well as managing slide distribution and directing the data to be collected against those slides. Any implemented system would have to ensure compliance with the Health Insurance Portability and Accountability Act (HIPAA) and Part 11 of the Code of Federal Regulations (CFR-11) governing Electronic Records and Electronic Signatures for U.S. collaborators.
Solution
5AM customized Glassbox, our flexible internet-based application that provides a foundation to medical researchers, clinicians, physicians, therapists, and scientists to collaborate on research and communicate in the context of a research project. Sophisticated yet customizable workflow, inventory tracking, and role-based information collection and sharing combine to make Glassbox a unique and powerful Internet application. Using the features that support enrollment, clinical data collection, specimen creation and tracking, 5AM was able to launch the study over a month’s time. Next, using the Glassbox framework and guided by the researchers, 5AM was able to create the modules required for organizing the block and slide creation and distribution mechanisms, in addition to the unique data requirements for the IHC scoring of the slides and the ability to extract all the relational data while preserving the integrity of patient confidentiality. 5AM also provided secure hosting, hourly data backups, online help and phone/email support.
Benefits
A key benefit occurred up front through the study definition and elicitation process. This series of activities sharpened the direction of the study, forced the analysis of how the research would be run from a variety of perspectives and allowed us to be able to incrementally meet the needs as they were derived. For the collaborators, Glassbox shares the effort and the gain from data generation for peer-reviewed manuscripts, fosters collaborative funding requests from Foundations and competitive funding requests from NIH, fuels discovery and the creation of Intellectual Property and demonstrates the strength and speed of collaborations. User adoption was quick as new collaborators were able to contribute within a half-hour of un-supervised training. HIPAA, data backup, encryption, in-house maintenance, collaborator/customer service and support are concerns eliminated through the use of Glassbox and 5AM services.