# Presentation: 215435

## DRIVING BIOLOGICAL PROJECT: ANALYSIS OF HIV TRIALS 

**DRIVING BIOLOGICAL PROJECT: ANALYSIS OF HIV TRIALS**
- Ida Sim, Simona Carini, Ben Olasov

- University of California, San Francisco

**Introduction**
- The National Center for Biomedical Ontology (http://bioontology.org) is a consortium that comprises leading informaticians, biologists, clinicians, and ontologists funded by the NIH Roadmap to develop innovative technology and methods that allow scientists to record, manage, and disseminate biomedical information and knowledge in machine-processable form.

**Domain Problem**
- Clinical science and practice advances are based on results from randomized controlled trials (RCTs).
- Randomization equalizes known and unknown confounders between intervention arms. Hence, any observed differences in outcome should be due only to the intervention.

- Regimen A

- Placebo

- Study population

- HIV transmission rate

- HIV transmission rate

- RCT results are published in journal articles not suited for computation. Hence clinicians, systematic reviewers and trial designers have difficulty finding, interpreting and applying RCT results to their practice.

**Objective**
- To drive the development and use of ontologies and ontology-based services to augment computational reasoning of RCTs. Examples include using ontologies to drive multi-dimensional visualizations and dynamic manipulation of heterogeneous trials and the use of vocabulary mapping services to semantically correlate RCTs with electronic patient records.

**The Trial Bank Project**
- The Trial Bank Project started answering the need for computational support by making clinical trial reports available in a machine-understandable "trial bank,” called **RCT Bank**. RCT Bank is a knowledge base that stores information on
-  design,
-  execution
-  results of RCTs.
- The data model for RCT Bank is a frame-based ontology called **RCT Schema**, the most detailed ontology in existence for the analysis and interpretation of RCTs.

**Analysis of HIV Trials as**** ****Driving Biological Project**

**RCT Bank**

**RCT Presenter: **a web-based program for browsing RCT Bank entries

**Specific Aims of the Driving Biological Project:**** **
**1.** to collect and annotate RCTs in the areas of MTCT and ART;
**2.** to use visualization techniques to identify similarities and differences among
-     those trials for meta-analysis (statistical technique used to combine the trials’
-     results) of available evidence;
**3.** to facilitate the automated determination of the applicability of RCT results to
-     patients, whose data is stored in an electronic medical record (EMR) system
-     and coded in a standard vocabulary (applicability indicates the degree of
-     relevance of the study to the patient); and
**4.** to inform the design of future trials to maximize the value of the evidence they
-     will provide.

**Bank-a-Trial: **a web-based program for entering trials into RCT Bank

**Electronic Medical Records**

**Open Biomedical Data**

**LexGrid**

**Applicability Engine**

**Meta-analysis**

**Visualizations**

**HIV trials**

**UMLS**

**SNOMED**

**Aim #1**

**Aim #2**

**Aim #3**

**Aim #2**

**Aim #4**

**Future Clinical Trials**

**Application**
- Two controversial areas with conflicting RCT evidence in the domain of HIV/AIDS prevention and care:
-  Prevention of mother-to-child transmission (MTCT)
-  Structured interruption of anti-retroviral treatment (ART)
- Trials in these areas are complex and heterogenous, hence the need for computational support to visualize, analyze and apply them to clinical practice.

**WHO/**
**CDISC XML**

**Conclusion**
- RCTs yield some of the most valuable evidence for the advancement of clinical science and practice. Our project will lead to advanced understanding of important and controversial issues in HIV/AIDS prevention and care, as well as to tools for analyzing RCTs in any other clinical domain.