# Presentation: 007672

## caBIG Workspace Overview, Scope and Needs

- February 19 & 20

**caBIG Workspace Overview, Scope and Needs**
**Clinical Trial Management Systems**

## Rules for Today’s Meeting

- We want to hear ALL and ANY ideas
- No idea, no question, no comment is too dumb
- Check egos at the door
- Let’s not get hung up on bits and bytes
- Apologies in advance to any toes we have stepped on

## Contents

**Contents**

**Goals of this Session**
- Workspace Structure
- Workspace Operations
- Workspace Participants and Scope
- Workspace Needs

## Workspace Breakout Session - Goals

- Learn about the relevant capabilities at the participating cancer centers and the NCICB
- Review the needs and interests of participating pilot Cancer Centers
- Discuss workspace requirements
- Review requirements for potential developer projects and identify key, near term milestones and activities.
- Review existing caBIG compliant solutions as the basis for early testing and integration by Adopter Centers
- Discover sources of data within the Workspace which can be shared on the grid as part of the pilot program
- Discuss group coordination and future meeting schedule
- Draft action plan summarizing conclusions

## Purpose of this Presentation

- Start today’s discussion from a common understanding
- Overview of caBIG Workspaces in general (structure and operations)
- Set the stage for the Workspace specific discussions
- Understand the scope and needs of the Clinical Trial Management Systems Workspace

## Contents

**Contents**

- Goals of this Session
**Workspace Structure**
- Workspace Operations
- Workspace Participants and Scope
- Workspace Needs

## Workspace Definition

- Central to the caBIG pilot initiative
- Areas where caBIG pilot project activities are grouped and coordinated
- Encompass activities with a common focus, addressing identified Cancer Center needs
- Create products and solutions including tools, standards, data and documentation
- Share and test products and solutions amongst pilot participants
- Develop products and solutions which will ultimately be open and shared among the cancer research community

## Workspace Types

- There are two types of Workspaces – Domain and Cross Cutting
- Clinical Trial Management Systems is a Domain Workspace

## Workspace Roles

**Developer**
- 	An NCI-designated Cancer Center selected and funded by NCICB to participate in a specific Workspace to undertake software or solution development activities.
**Adopter**
- 	An NCI-designated Cancer Center selected and funded by NCICB to undertake formal testing, validation and application of products or solutions developed by Workspace Developers and existing caBIG compliant solutons.
**Workspace Working  Group**
- 	A group of NCI-designated Cancer Center members (and other invited stakeholders) funded to provide guidance and support for Workspace activities.  The Working Group includes representatives from the Developer and Adopter teams.

## Slide 10

## Contents

**Contents**

- Goals of this Session
- Workspace Structure
**Workspace Operations**
- Workspace Participants and Scope
- Workspace Needs

## Workspace Principles of Participation

- Support the spirit, vision, goals and principles of the caBIG initiative as a whole
- Collaborate effectively with other Workspace participants and groups to support specific and overarching goals
- Collaborate effectively with other Workspaces and Working Groups (Workspace and Strategic levels) to support specific and overarching goals
- Undertake activities with integrity and objectivity
- Perform activities in a consensus driven manner
- Respect and capitalize on the skills and merits of individual participants
- Act in accordance with the caBIG Oversight Board and Master Contractor guidelines and processes

## Workspace Communications 

- The success of the caBIG network relies on communication and coordination between caBIG participants
- Mechanisms will be established to ensure effective communications both within Workspaces and between Workspaces/Working Groups
- e.g., Face-to-face meetings
- e.g., Electronic Program Updates
- e.g., Web based tools
- The Cross Cutting Workspaces and the Strategic Level Working Groups address issues of common concern across caBIG and will promote communications across Workspaces

## Workspace Performance

- As part of undertaking Workspace activities, Workspace participants
- are asked to:
- Perform in accordance with their contracts and charters
- Meet agreed work plans, milestones and deliverable schedules
- Support processes as delineated by the caBIG coordination and oversight groups, including those for performance planning, monitoring and reporting
- Support the vision, goals and principles of caBIG
- Perform activities within agreed scope and budget

## Workspace Coordination

- Workspace participants are responsible for the coordination of their Center level caBIG related projects and activities according to agreed Statements of Work and contracts
- Overarching coordination of Workspace activities is undertaken by the Master Contractor (contracting team appointed by NCICB)
- Workspace participants are asked to support processes established by the Master Contractor to ensure the coordination of caBIG activities

## Contents

**Contents**

- Goals of this Session
- Workspace Structure
- Workspace Operations
**Workspace Participants and Scope**
- Workspace Needs

## Clinical Trial Management Systems: Workspace Goals

- Improve clinical research productivity
- Integration of the clinical trials infrastructure with the research infrastructure (in conjunction with Integrated Cancer Research Workspace)
- Allow sharing of de-identified data across trials and sites
- Facilitate greater standardization of coding, vocabulary, nomenclature and data collection methods as part of clinical trials
- Define specifications to be followed by developers of new or existing clinical trials systems intended to be compatible with caBIG
- Consistency with NIH Roadmap direction (_[http://nihroadmap.nih.gov/](http://nihroadmap.nih.gov/)__)._

## Clinical Trial Management Systems:Workspace Participants

## Clinical Trial Management Systems: Workspace Scope

- Near-term:
- Adoption of existing tools that are already caBIG-compatible or can be quickly made caBIG-compatible
- Development of a strategic vision for the workspace, detailed specifications, and a defined path for migration
- Work with Integrated Cancer Research Workspace on clinical trials interoperability with other domains
- Work with vocabulary workspace to facilitate greater standardization of coding, vocabulary, and nomenclature
- Work with architecture workspace to define specifications for caBIG compatibility, and to define infrastructure requirements
- Ultimately, the efforts should result in a set of related and interoperable tools for clinical data management, arising from the efforts and specific interests of all the Workspace participants

## Contents

**Contents**

- Goals of this Session
- Workspace Structure
- Workspace Operations
- Workspace Participants and Scope
**Workspace Needs**

## Clinical Trials Management Systems: Challenges 

- Heavily manual, paper-based processing
- “Islands of Information”
- Syntactic interfaces vs. semantic interoperability
- Variable/conflicting vocabulary, coding and nomenclature standards
- Every trial is “de novo”
- Time/money spent on building infrastructure, rather than scientific and research endeavors
- Sociological barriers to change

## Results – Examples from Drug Discovery/Development

- In 2002, FDA only approved 17 drugs, the lowest rate of approval in nearly 20 years
- Each year, more than 80,000 clinical trials are conducted in the US and about 95 percent of these are still paper base
- $800 million and 15 years to bring a new drug to market

## Need for a New Approach

- “The world we have created today has problems which cannot be solved by thinking the way we thought when we created them”
- 		- Albert Einstein

## Clinical Trials Management Systems: Needs

- Improved productivity
- Paper follows the work, rather than driving the work
- Manual processes significantly reduced
- Eliminate “islands of information”
- Computational semantic interoperability
- Sharing of de-identified clinical data
- New, innovative approaches clinical research
- Advance discoveries from bench to bedside and back
- Integration of clinical trials and research infrastructure

## Trials vs. Research Infrastructure at NCICB

## Clinical Components

- Services
- Participant Registry
- Adverse Events
- And more ...
- Toolkits
- HL7 RIM SDK
- Patient De-identification
- Security
- And more ...

- Engines
- Workflow Engine
- Report Generator
- Document Management
- Messaging
- And more ...

## CTMA and the University of Pittsburgh Clinical Trials Research Core

- Administrative and Regulatory Management
- Clinical Research Management
- Financial Management
- Study Parameters Development
- Data mining and De-Identification
- Patient Enrollment

## Critical Success Factors (1)

- Completeness and strength of vision
- Scientific and clinical requirements well understood
- Participants challenge everything and are innovative in looking for solutions to problems.
- Community willing/able to accept radical change
- New technology implemented in new ways with new results
- Team approach.
- Participants are open and honest about issues/problems.

## Critical Success Factors (2)

- All participants have a clear and common understanding of project goals, objectives, timelines, deliverables, etc.
- Participants (full-time and part-time) attend meetings as required and adhere to deadlines and schedules.
- Detailed planning and close tracking of project progress.
- Adherence to established scope and avoidance of scope creep.
- Superheroes that live the mission

## It’s a Team Effort!