# Presentation: 406706

## NCCCP Information Technology Break-Out

*NCI Center for Bioinformatics and*
*Information Technology*

- NCI Community Cancer Centers Program Pilot Launch
- June 26, 2007

## Agenda

**Introductions**
**caBIGTM Program Overview**
**Overview of NCCCP Informatics Activities**
**Site overviews and discussion: Strengths, Capabilities and Needs**
- Current status of IT infrastructure
- What systems are in place to support clinical operations?
- What systems are in place to support research?
- Are any clinical operations software systems currently supplying data to research systems automatically?
- Any linkages/collaborations with NCI-designated cancer centers/other centers that involve IT efforts?  Is data shared with them?
**Next Steps, Logistics**

## Introductions

**NCI Center for Biomedical Informatics and Information Technology (CBIIT)**
**Ken Buetow, Ph.D.**
- Director
**Leslie Derr, Ph.D.**
- Director, Community Alliances and Support
**John Speakman**
- Associate Director, Clinical Trials Products and Programs

## caBIGTM:NCI’s Platform for Molecular Medicine

## Molecular Medicine: Personalized Approaches

**Molecular Medicine: Personalized Approaches**

## caBIGTM Defined

**A virtual web of interconnected data, individuals, and organizations redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise**

**Next generation World Wide Web****of biomedical research**

## caBIGTM Mission

**caBIGTM Mission**

**Connect** the cancer research community through a shareable, interoperable infrastructure
**Deploy **and Extend standard rules and a common language to more easily share information
**Build** or adapt tools for collecting, analyzing, integrating and disseminating information associated with cancer research and care

## caBIGTM Imperatives

**caBIGTM Imperatives**

- Integrate the biological and clinical silos

- Integrate IT infrastructure, software and data

- Integrate institutions and people

**Address the complexity of cancer**

## Molecular Medicine as a Complex Continuum

**Molecular Medicine as a Complex Continuum**

**Clinical Research**

**Pathology**

**Molecular Biology**

**Imaging**

**Molecular Medicine**

## The People

**The People**

## The People

**The People**

## The People

**The People**

## The People

**The People**

## The Activities

**The Activities**

**Clinical Trial****Management**

## The Activities

**The Activities**

**Image Sharing ****& Analysis**

- Cross-reference image archive to improve detection and diagnosis.

## The Activities

**The Activities**

**Tissue Banking**

- Collect, process, annotate, archive and disseminate tissue samples from patients.

## The Activities

**The Activities**

**Molecular Profiling**

## caBIG Approach

** ****Modules that address****  specific needs**
** ****Use of international data ****  standards**
** ****Connect through defined****  Electronic interfaces**

## Boundaries and Interfaces

**Boundaries and Interfaces**

** ****focus on boundaries, interfaces, how things fit together, not on the internal details**
**  ****once they’re built: assume they will be diverse & changing**

## Addressing real world issues

**Notes:**
As you are well familiar, we created Workspaces where communities work on specific collections of problems; specific research interest groups that build tools and share data; how a community comes together to work on specific activities.

Cross-cutting workspaces support the construction of basic infrastructure, knitting together the caBIGTM community at infrastructure level.

## Standards as a process

**caBIG ****Compatibility ****Guidelines**

## Supporting infrastructure and services

**Enterprise Vocabulary Services (EVS)**
**Browsers**
**APIs**
**cancer Data Standards Repository (caDSR)**
**CDEs**
**Case Report Forms**
**Object models**
**caGrid**
**Globus**
**Mobius**
**Introduce**
**Dorian **
**Grouper**
**ActiveBPEL**
**Developer Toolkits**
**caCORE SDK**

## The Clinical Research “World of Standards” Today

**The Clinical Research ****“World of Standards” Today**

- One harmonized standard/model: **Biomedical Research Integrated ****Domain Group** (BRIDG)

## caGrid 1.0 Conceptual View

**caGrid 1.0 Conceptual View**

## The Software Tools

**The Software Tools**

**Clinical Trial****Management**

**Patient Study Calendar (PSC)**** **
**Cancer Central Clinical Patient Registry ****(C3PR)**** **
**Cancer Central Clinical Database (C3D)**

## The Software Tools

**The Software Tools**

**Imaging**

**National Cancer Imaging Archive (NCIA)**

## The Software Tools

**The Software Tools**

**Tissue Banking**

**caTissue**
**caTIEs**
**Clinical annotations**

## The Software Tools

**The Software Tools**

**Molecular Profiling**

**caARRAY/geWorkbench**** **
**caIntegrator**** **
**Cancer Translational Informatics Research Platform (caTRIP)**

## caBIG Application Bundles

**Electronic Clinical Trials Management**
**Connecting through caBIG and its biomedical research applications **
**Security and Data Sharing**** **

## CTMS Bundle: Details

**The CTMS Bundle brings together a range of interoperable tools supporting the clinical trials enterprise.**
**Functions include:**
*Patient Study Calendar (PSC)*
*Participant Registry (C3PR)*
*Adverse Event Reporting (caAERS)*
*Clinical Source Data Integration (caXchange)*
*Integration with Cancer Central Clinical Database (C3D), or with commercial clinical trials data collection tools at sites*

**CTMS Bundle**

## CTMS Bundle: Patient Study Calendar (PSC)

***Automatically generated study-template-based patient calendar***
***Accurate, versioned representation of study parameter table***
***Prospective forecasting of patient visit information ***
***Management of study participant schedules (schedule, reschedule, cancel)***
***Retrospective outcomes review and reporting of calendar activities***
***Consent / reconsent notification and tracking***

## CTMS Bundle: Adverse Event Reporting (caAERS)

***Adverse Event Tracking and classification using accepted standards***
***Data import / export AE data in common/required formats***
***Automated, rules-based assessment of seriousness and reporting requirements (sponsor-level, institution-level and protocol-level rules)***
***Reporting, including generation of CTEP, DCP, and FDA compliant reports***
***Ability to submit electronically to CTEP AdEERS system***

## CTMS Bundle: Participant Registry (C3PR)

***Verifies registration criteria (study open, participant eligible, consent received)***
***Stratifies subject into a stratum group, randomizes to the trial***
***Tracks participants across sites (handles multi-site trials)***
***Manages study personnel***
***Reporting  (federal/local requirements, supplies NCI Summary 3/4 data)***

**CTMS Bundle: Participant Registry (C3PR)**

## CTMS Bundle: Clinical Source Data Integration (caXchange)

***Accumulates results in a standards-based data warehouse with defined electronic interfaces ***
***Translation of multiple source data formats into standards-compliant data for use in clinical trials***
***Incorporates Viewer – enabling viewing and selection of data***

**CTMS Bundle: Clinical Source Data Integration (caXchange)**

## Clinical Data Warehouse

**Local**
**Clinical **
**Systems**

- Labs,
- EMR,
- Tissue,
- etc.

**Clinical**
**Trials**

**caXchange**

**Clinical**
**Data Mgmt**

- EDC

- Adverse Events

- Participant Registry

- etc.

**Research****Data****Warehouse**

**Patient****Health****Record**

- Lifecycle Management

## Biomedical Informatics Bundle: Details

**The Biomedical Informatics Bundle brings together a range of caGrid-interfaced tools supporting biomedical informatics**
**Functions include:**
*Tissue Banking (caTISSUE Suite)*
*Gene Expression Database (caArray)*
*Translational Medicine tools (caIntegrator)*
*Biomedical Image Management (NCIA)*
*Array analysis (geWorkbench)*
*...**and the supporting caGrid infrastructure ...*

**Biomedical Informatics Bundle**

## Biomedical Informatics Bundle: caTISSUE

**Product Description:**
- caTissue Core is caBIG's tissue bank repository tool for biospecimen inventory, tracking, and basic annotation. Version 1.1 of caTissue permits users to track the collection, storage, quality assurance, and distribution of specimens as well as the derivation and aliquotting of new specimens from an existing ones (e.g. for DNA analysis). It also allows users to find and request specimens that may then be used in molecular, correlative studies.

**Current Version Number: **Version 1.1
**Release Date of Current Version: **February 2007** **
**caBIGTM Compatibility Level: **Silver**Maturity Assessment: **Stable Release

## Biomedical Informatics Bundle: caARRAY

**Product Description:**
- caArray is an open source microarray data management system that allows users to submit, annotate and download microarray data. caArray was developed using the caBIG compatibility guidelines, as well as the Microarray Gene Expression Data (MGED) society standards for microarray data. Compatibility with these standards and guidelines will facilitate data sharing and integration of diverse data types including clinical, imaging, tissue and functional genomics data. A number of analytical tools that connect to caArray are already available, including geWorkbench and GenePattern that both provide a variety of data analysis, visualization and annotation functions for microarray and other data types.

**Current Version Number: **Version 1.4
**Release Date of Current Version: **October 2006** **
**caBIGTM Compatibility Level: **Silver**Maturity Assessment: **Stable Release

## Biomedical Informatics Bundle: NCIA

**Product Description:**
- The National Cancer Imaging Archive (NCIA) is a searchable, national repository integrating in vivo cancer images with clinical and genomic data. NCIA provides the cancer research community, industry, and academia with public access to: DICOM images, Image markup, Annotations, and rich meta data.

**Current Version Number: **Version 2.2
**Release Date of Current Version: **January 2007
**caBIGTM Compatibility Level: **Silver**Maturity Assessment: **Mature Product

## Biomedical Informatics Bundle: geWorkbench

**Product Description:**
- geWorkbench provides an innovative, open-source software platform for genomic data integration, bringing together analysis and visualization tools for gene expression, sequences, pathways, and other biomedical data. It gives scientists transparent access to a number of external data sources and algorithmic services, combining these with many built-in tools for analysis and visualization (at present more than 40 distinct analysis and visualization modules are part of the platform).

**Current Version Number: **Version 1.0.4
**Release Date of Current Version: **August 2006
**caBIGTM Compatibility Level: **In process
**Maturity Assessment: **Stable Product

## Biomedical Informatics Bundle: caIntegrator

**Product Description:**
- caIntegrator is a novel translational informatics platform that allows researchers and bioinformaticians to access and analyze clinical and experimental data across multiple clinical trials and studies. The caIntegrator framework provides a mechanism for integrating and aggregating biomedical research data and provides access to a variety of data types (e.g. Immunohistochemistry (IHC), microarray-based gene expression, SNPs, clinical trials data etc.) in a cohesive fashion.

**Current Version Number: **Version
**Release Date of Current Version:**
**caBIGTM Compatibility Level: **Silver**Maturity Assessment: **Stable Release

## DSIC Bundle: Details

**DSIC Bundle: Details**

**DSIC Bundle**

**The DSIC Bundle provides a critical range of processes, procedures, policies and template agreements that provide a framework for collaboration**
**Bundle includes:**
*Master Guidance Document*
*Flow document and questionnaire*
*Decision tree*
*Template agreements for MTA, IRB, etc.*
*Security policies, procedures, and a framework for caGrid-wide authorization*
*...**and a framework for participating in the DSIC process, refining the structure for data sharing throughout the program ...*

## CBIIT caBIG Support Approaches

**CBIIT Application Support**
- E-mail
- Phone support
- List Servers
**caBIG “boot camps”**
- Developers
- Application Users
**Online Interactive Training **
**Down-loadable User Materials**
**Training Sessions at Scientific Meetings**

## caBIG Enterprise Support Activities

## caBIGTM: Power of Connection

## Overview of NCCCP Informatics Activities

## Our Remit

***“******[To] increase knowledge of infrastructure requirements, necessary interfaces, and  applicability of specific components of NCI’s Cancer Biomedical Informatics Grid (caBIGTM) program for community hospital settings”***
***“******[To] increase implementation of electronic medical records and exploration of the application of electronic medical records in the provision of cancer care”***

## Utilizing caBIGTM

**Organizations *****leverage***** caBIGTM through the following:**
- Accessing the capabilities of caBIGTM, including software, data standards, training, documentation, and support
- Applying caBIGTM to achieve bench-to-bedside-to-bench molecular medicine
- Applying caBIGTM beyond cancer to other diseases
- Building on/contributing to caBIGTM policies and procedures

## “Baseline” (all sites)

**Year 1: Plan**
- Assess informatics capabilities/challenges of each site, stratify sites into tiers, determine strategy
**Year 2: Do**
- Execute according to plan(develop detailed plan for implementing/leveraging caBIG)
**Year 3: Assess**
- Evaluate execution according to plan
- Document lessons learned(barriers to implementation, successful strategies, future opportunities)

## Cancer Community IT Landscape

- Integrated Systems
- Homegrown/Commercial
- Smooth navigation between applications
- Difficult to expand/extend
- Large IT staff
- $10M’s invested

-  Heterogeneous      Systems
- Complex mix of commercial and homegrown components (may be composed of dozens of components)
- No common interfaces
- Medium size IT staff
- $1M’s invested

-  Informal/  no systems
- Use of productivity applications (e.g. Excel, Access)
- Complex manual processes
- Small or no IT staff
- $100K’s invested

## Stratification of sites: Tier 1

**Year 1: Plan, Year 2: Do, Year 3: Assess**

***Baseline***

## Sample Tier 1 Applications from the caBIGTM Portfolio

| Application | Functionality | Area(s) of applicability |
| --- | --- | --- |
| C3PR | Subject/participant registry | Clinical Trials, Biospecimens |
| caTissue | Biospecimen repository | Biospecimens |
| caMATCH | Eligibility prescreening | Clinical Trials, Disparities |
| caXchange | Automated transfer of clinical data | Clinical Trials, Biospecimens |
| C3DS | Clinical research environment | Clinical Trials |

## Stratification of sites: Tier 2

**Year 1: Plan, Year 2: Do, Year 3: Assess**

***Baseline***

***“******Tier 1”***
***sites***

**Baseline plus: Collaboratively identify and deploy caBIGTM tools that would add value to the site, either**
- using NCI as an application service provider, or
- installing infrastructure locally, or
- adapting local systems to share data in a caBIGTM compliant manner

## Site Overviews and Discussion

## Strengths, Capabilities and Needs

- Current status of IT infrastructure
- What systems are in place to support clinical operations?
- Types
- Vendors
- Standards
- What systems are in place to support research?
- Do you have a structured data warehouse/repository in place?
- What structured data sources do you have in place that might feed a data warehouse?
- Are any clinical operations software systems currently supplying data to research systems automatically?
- Any linkages/collaborations with NCI-designated cancer centers/other centers that involve IT efforts?  Is data shared with them?
- Needs/ Desires

## Next Steps and Logistics

## Next Steps / Logistics

- We need IT contact(s) at each site
- How would you like to communicate
- E-mail listservs
- Online forums
- Other?
- Regularly scheduled teleconferences
- Monthly, twice monthly?
- Tues/Thurs 1-3 ET timeframe preferred
- Your next steps
- Comprehensive site evaluation
- Participate in caBIG
- _[http://cabig.nci.nih.gov](http://cabig.nci.nih.gov/)_
- Join caBIG Announce listserv