# Presentation: 662074

## Integration of Clinical Trials Working Group Informatics-based Recommendations into the caBIGTM Program

***Kenneth Buetow, Ph.D.***
***Assoc. Dir. for Bioinformatics & Information Technology***
***National Cancer Institute ***
***National Institutes of Health***

***Session # 1***
* **Monday, May 22, 2006*
*12:00 Noon – 1:30 PM EST*
***Session # 2***
* **Tuesday, May 23, 2006*
*1:30 – 3:00 PM EST*

## Agenda

- Introductions
- The CTWG Report: Background and History
- Introducing the new CTWG Informatics-based Initiatives
- Introduction to the caBIGTM Program and the Clinical Trials Management Systems (CTMS) Workspace
- How members of the Cancer Research Community can become involved in the CTWG Informatics-based Initiatives
- Summary & Next Steps

## The Clinical Trials Working Group (CTWG)

- In January 2004, the Director of the National Cancer Institute (NCI) established the Clinical Trials Working Group (CTWG) to provide recommendations to the National Cancer Advisory Board (NCAB) on whether, and in what ways, the NCI-supported national clinical trials enterprise should be restructured to realize the promise of molecular medicine for advancing oncologic clinical practice in the 21st century.

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## The Clinical Trials Working Group (CTWG)

- The CTWG was a broadly constituted panel with experts from academic research institutions, community oncology practices, the pharmaceutical and biotechnology industries, cancer patient advocacy groups, NCI, the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS).

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Clinical Trials Working Group (CTWG) ReportRestructuring the National Cancer Clinical Trials Enterprise 

**CTWG Vision Statement**
*Enhance the best of all the components of the NCI-supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders.*

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Goals for Restructuring the National Cancer Clinical Trials Enterprise

***The CTWG reached consensus on four goals for designing a restructured national clinical trials enterprise.***
- The first goal is to ***improve coordination and cooperation*** among the functionally diverse components of the current system, including industry and federal regulatory agencies.
*The resulting ****Coordination Initiatives**** are directed at enhanced information sharing, incentives for collaborative team science, and coordination of regulatory processes.*

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Goals for Restructuring the National Cancer Clinical Trials Enterprise (continued)

- The second goal is to ***improve prioritization and scientific quality*** by developing an open and transparent process for the design and prioritization of clinical trials that are science-driven and meet the needs of patient care.
*The resulting ****Prioritization/Scientific Quality Initiatives**** establish new processes for the design and prioritization of clinical trials, and for facilitating the conduct of correlative science and other ancillary studies.*

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Goals for Restructuring the National Cancer Clinical Trials Enterprise (continued)

- The third goal is ***to improve standardization of tools and procedures*** for trial design, data capture, data sharing, and administrative functions to minimize duplication of effort, and ***to facilitate development of a shared infrastructure ***to support an integrated national cancer clinical trials network.
*The resulting ****Standardization Initiatives**** promote development of standardized tools and procedures to minimize duplication and reduce the effort required to initiate and conduct clinical trials.*

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Goals for Restructuring the National Cancer Clinical Trials Enterprise (continued)

- The fourth goal is to ***improve operational efficiency*** by increasing the rate of patient accrual and reducing operational barriers so that trials can be initiated and executed in a timely, cost-effective manner.
*The resulting ****Operational Efficiency Initiatives**** focus on improving patient accrual rates and reducing operational barriers to speed both the initiation and conduct of clinical trials.*

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Clinical Trials Working Group (CTWG) Report Summary 

- The initiatives resulting from the CTWG report are designed to support a powerful and transparent clinical trials enterprise that integrates the individually strong components of the current system into a ***cross-disciplinary, scientifically-driven, cooperative research effort.***
- The result of this broad-based, strategically-driven effort, involving all the critical stakeholders in the cancer clinical trials community, is the compendium of 22 initiatives detailed in the CTWG Report.

- CTWG Report: http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf

## Delivering on four related informatics-based initiatives highlighted in the CTWG Report

- Establish a Comprehensive Community-Accessible NCI Clinical Trial Database
- Promote Information Sharing &        Exchange between Systems           Supporting NCI Clinical Trials
- Establish a Core Library of          Standardized Case Report Forms        (CRFs) through Stakeholder          Consensus
- Develop a Credentialing System for Investigators and Sites

## Establish a Comprehensive, Community- Accessible NCI Clinical Trials Database 

- Establish Cancer Research Community involvement in Clinical Trials Database definition, development and adoption activities
- Define community needs for secure and transparent access to NCI clinical trial data and information
- To establish a single source for NCI clinical trial data
- To provide transparency on the status of clinical trials
- To support expansion of the database to include data from other public- and private-sector sponsors
- To enhance ability to compare and analyze data across trials with structured, electronic data & information
- Define and execute NCI Clinical Trials Database implementation plan leveraging caBIGTM design principles and implementation standards

## Promote Information Sharing & Exchange between Systems Supporting NCI Clinical Trials

- Establish on-going Cancer Research Community involvement in to opportunities to promote information sharing and exchange
- Define Cancer Research Community information sharing and exchange needs
- Align NCI internal and external IT systems to share and exchange research data, information and knowledge
- To enable secure and transparent NCI community access to clinical trials research data
- Develop a portal to support Clinical Trial Research activities including tools and services to support protocol initiation activities

## Establish a Core Library of Standard CRFs Developed through Stakeholder Consensus 

- Establish on-going Cancer Research Community involvement in CRF Standardization activities
- Define Cancer Research Community data capture needs
- Establish a core library of standardized CRFs developed through stakeholder consensus
- To reduce time, cost and effort of initiating & executing clinical research trials
- To facilitate the regulatory review process
- To enable standardized data capture to enhance investigator ability to compare and analyze data across trials
- To eliminate the capture of clinically insignificant data elements

## Develop a Credentialing System for Investigators and Sites

- Establish on-going Cancer Research Community involvement in credentialing system definition, development & adoption activities
- Define Cancer Research Community investigator and site credentialing system needs
- To speed and simplify the trial initiation process
- To facilitate communication of changes in the status of individual investigators and sites to sponsors.
- To help keep the investigative community abreast of new trends in clinical trials, including legal, safety, and regulatory changes
- Explore existing credentialing systems
- Implement Investigator and Site Credentialing System

## The Clinical Trial Working Group’s Call to Continue Building upon the caBIGTM Informatics Foundation 

*To create, in partnership with the extramural community, a national cancer clinical trials information technology infrastructure fully interoperable with NCI’s cancer Bioinformatics Grid (caBIGTM) to improve the cost effectiveness and comparability of results across trials.*

- CTWG Report: _[http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf](http://integratedtrials.nci.nih.gov/ict/CTWG_report_June2005.pdf)__ _

## The caBIGTM Mission

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

## The caBIGTM Objectives

***caBIGTM is developing and promoting:***
- A common, widely distributed infrastructure that permits the cancer research community to focus on innovation
- Shared vocabulary, data elements, data models which facilitate information exchange
- A collection of interoperable applications developed to common standards
- Solutions which make raw published cancer research data available for mining and integration

## Introducing the Structure of the caBIGTM Program

**caBIG****TM**** Architecture Workspace**

**caBIG****TM ****Vocabularies and Common Data Elements Workspace**

**Strategic Planning  Workspace**

**Training Workspace**

**Integrative Cancer Research      Workspace**

***In Vivo*****   Imaging Workspace**

**Tissue  Banks & Pathology Tools Workspace**

**Data Sharing & Intellectual Capital Workspace**

- Introducing the Structure of the caBIGTM Program

**Clinical  Trials Management Systems      Workspace**

## Community Participation in the caBIGTM Clinical Trials Management Systems (CTMS) Workspace (WS)

***CTMS Steering Committee***** **
- Helps establish & drive the overall Clinical Trials Enterprise Informatics vision
- Establishes overall cross-cutting priorities and defines high-level strategic & tactical approaches for meeting Clinical Trials Enterprise Informatics vision

***Project Teams / Special Interest Groups (SIGs)***
- Provide priorities & direction for specified topic area
- Define requirements for tools and applications

## Immediate Next Steps

- Establish teams to support initiatives
- Align participant representation on teams with initiative goals & objectives
- Identify participation gaps and solicit individuals to close gaps in required roles or expertise
- Obtain community input on additional activities or initiatives to support the CTWG Goals
- Conduct Kick-off activities associated with each of the initiatives

## Timeline for caBIGTM Activities

**2007**

**2008 **

**2006**

**LEGEND:****	****Clinical Trials Database (CTDB) Activities****	****Data Sharing & Exchange Activities**
**	****Case Report Form (CRF) Activities****	****Credentialing Activities**

## Timeline for New caBIGTM Activities in 2006

**LEGEND:****	****Clinical Trials Database (CTDB) Activities****	****Data Sharing & Exchange Activities**
**	****Case Report Form (CRF) Activities****	****Credentialing Activities**

**Oct - Dec**

**May **

**June**

**July **

**August**

**September**

## What does this mean to the Clinical                   Trial Research Community?

- Your input and contributions will ultimately drive this process. As a participating trialist, you will provide critical input into these informatics-based initiatives that reflects your organization’s needs.
- The technical participants can define and build the technical solutions, but the clinician and / or functional or domain expert will define the research, regulatory and process requirements that will make this effort successful.

## Summary

***Expansion of the caBIGTM program under the CTMS Workspace will:***
- Establish four new initiatives within the workspace to support the informatics recommendations highlighted in the CTWG Report
- Develop & implement tactical plans for meeting initiative objectives
- Increase Cancer Research Community participation in the CTMS Workspace
- Establish a formal Clinical Trials Management Systems Steering Committee to support the broader workspace coordination activities
- Leverage existing caBIGTM and other existing NCI and community efforts to support expanded workspace activities

## How can you become involved?

- To learn more about, or to become a member of one of the 4 new initiatives / SIGs being established, please send an email message to ctms_sigs@bah.com (ctms_sigs@bah.com) indicating your interest in participating and identifying which of the new informatics-based SIGs you would like to be a part of.

## What you need to know to participate in one or more of the upcoming activities 

***Now is the time for you to become involved!***

| SIG | START DATE
& TIME | TELECON INFO | LISTSERV |
| --- | --- | --- | --- |
| NCI Clinical Trials Database | June 7, 2006
1:30–3:00 PM EST  | 1-800-857-4523
Pass Code: 80757  | https://list.nih.gov/archives/cabig_ctms_ctdbsig-l.html  |
| Information Sharing & Exchange between Systems  | June 8, 2006
2:00–3:30 PM EST | 1-800-857-4523
Pass Code: 83554   | https://list.nih.gov/archives/cabig_ctms_hisig-l.html |
| CRF Standardization  | June 12, 2006 11:30 AM–1:00 PM EST | 1-800-857-4523
Pass Code: 99435  | https://list.nih.gov/archives/cabig_ctms_crfsig-l.html   |

- SIG to Develop a Credentialing System for Investigators and Sites will be established in July / August

## Thank You!

- Please sign up on the caBIGTM CTMS LISTSERV if you would like to be informed of on-going CTMS activities  _[https://list.nih.gov/archives/cabig_ctms-l.html](https://list.nih.gov/archives/cabig_ctms-l.html)_
- More information about caBIGTM CTMS Workspace please contact the CTMS Workspace Lead, Meg Gronvall at _[Gronvall_Margaret@bah.com](mailto:Gronvall_Margaret@bah.com)__  or by visiting the CTMS Workspace https://cabig.nci.nih.gov/workspaces/CTMS/ _
- For more information regarding these new initiatives, please send and email with your questions to ctms_sigs@bah.com (ctms_sigs@bah.com)

***Now is the time for you to become involved!***

## Q & A