Trial Reporting and the Human Studyome Project

The Trial Bank Project (summarized here) has moved away from pursuing trial bank publishing to explore new research avenues for several reasons. First, the registration of clinical trials into national registers like ClinicalTrials.gov is now a global policy. Dr. Sim led the establishment of this policy when she was the founding Project Coordinator of the International Clinical Trials Registry Platform at the World Health Organization. Second, the FDA Amendments Act of 2007 also requires the reporting of basic results into ClinicalTrials.gov. This greatly welcomed worldwide effort to make trial registration and reporting required means that setting up and running trial registers and results reporting websites has become an administrative and operational effort, rather than a research one. The real scientific opportunity is now in the sharing and re-use of human studies data for large-scale high-throughput computation of what we are calling the human studyome (the totality of all human studies worldwide). Our efforts are now aimed at collecting study information from as early in the study lifecycle as possible, and to ensure the distributed data sharing of human studies design and results information from multiple database using the shared semantics of the Ontology of Clinical Research. 

The Trial Bank Project's work is currently focused on two major areas:

  1. The Ontology of Clinical Research (OCRe), a reference ontology for the interpretation of human studies
  2. HSDBgrid, a caGrid-based architecture for federated data-sharing of human studies data using OCRe as the reference semantics, now with participation of 15 major US academic medical centers and increasing interest from UK and Europe

The applications developed by the Trial Bank Project are:

  • RCT Presenter (a subset of pages is available for browsing)
  • Bank-a-Trial (no longer available online; you can view the underlying model, RCT Schema)

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