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Clinical Research Informatics: Using CDISC Standards to Create Formal and Computable Representation of Human Clinical Research Protocols

Tuesday, September 23, 2014 — Poster Session III

12:00 p.m. – 2:00 p.m.

FAES Academic Center



* FARE Award Winner


  • V Huser


The field of clinical research informatics (CRI) tries to improve research efficiency by creating standards for describing human clinical trial design to IRBs, investigator sites, trial registries and regulators (e.g., FDA). We have analyzed the text of several clinical trials protocols (terminated 2+years ago or published) to contribute to the Protocol Representation Working Group within Clinical Data Interchange Standards Consortium (CDISC) that aims to develop XML-based protocol standard. Clinical protocol typically describes trial’s rationale, objectives, methodology, and statistical and other considerations. We qualitatively analyzed frequency of selected sections (e.g., subject withdrawal criteria, blinding or adverse event reporting). For a separate informatics project targeting drug-protocol interactions, we also looked at whether and how protocols describe medications permitted (including rescue medication) and not permitted before or during the trial. NIH BTRIS systems catalogs 7987 completed studies of which 7615 are terminated 2+years ago. Protocol information is important when secondary hypotheses are explored within BTRIS. We have also created automated script that links study result articles within PubMed to terminated protocols. Our analysis contributes to improving NIH protocol authoring tool as well as to CDISC efforts to develop universal protocol representation format (for use by WHO-accredited trial registries) and research enterprise at large.

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