# Presentation: 683121

## Talking to Your Center: Understanding the Adopt-Adapt Decision

***February 2008***

## Topic and Audience

**This presentation is for Cancer Center decision-makers and evaluation teams that are deciding how best to ****Connect with caBIGTM**
**Topics:**
- The Vision of caBIGTM
- Understanding the Adopt-Adapt Choice
- More about Adopt: Using caBIGTM Tools
- More about Adapt: Adapting Tools to be caBIGTM-compatible
- Summary and Next Steps

**Training Overview:**

## Topic 1: The Vision of caBIGTM 

## caBIGTM Overview

**caBIGTM Overview**

- 	**caBIGTM is an information network enabling all constituencies in the cancer community – researchers, clinicians, patients – to share data and knowledge to accelerate the discovery of new diagnostics and therapeutics, and improve patient outcomes.**
**	****caBIGTM Vision**
**Adapt or Build** tools for collecting, analyzing, integrating and disseminating information associated with cancer research and care
**Connect** the cancer research community through a shareable, interoperable infrastructure
**Deploy and Extend** standard rules and a common language to more easily share information

**Notes:**
“For those new to caBIGTM here is a quick view of the overarching caBIG TM mission and vision.  When you connect with caBIGTM, you aren’t just using a tool, you are connecting with a larger community striving to accelerate discovery in cancer research.  We want to connect people through a shared infrastructure, make it easier to share information where appropriate, and provide tools that support a life cycle of research and care.”  

## Transforming Scientific Research

- Biomedicine and cancer research are moving towards a new understanding of the molecular basis of disease.
- Information technology, biomedical informatics, and the adoption of standards are accelerating the collection, analysis, integration and dissemination of information – transforming data into knowledge essential to advancing cancer research, diagnosis and care.
- In connecting with caBIGTM, we are playing a critical role in this work.

## Facilitate collaborative research
Increase the research potential from data sets and accelerate the  extension to diagnosis and treatment 
Gain access to and share biomedical research data, within our center and with collaborators
Learn about the tools and resources to share, and promote our own services to others. 

- Facilitate collaborative research
- Increase the research potential from data sets and accelerate the  extension to diagnosis and treatment
- Gain access to and share biomedical research data, within our center and with collaborators
- Learn about the tools and resources to share, and promote our own services to others.

*The increased data sharing made possible by ****Getting Connected with caBIGTM**** increases the effectiveness and efficiency of cancer research, helping individual scientists, the cancer research community, and – ultimately – the patients.*

**caBIGTM Benefits**

**Notes:**
For basic researchers: Access to data sets in standardized formats accelerates studies and avoids repetitive efforts. Sharing data in a std format increases power of the data set, because of larger sample sizes. This avoid rediscovering the same thing. 
For clinical researchers: Faster, more efficient clinical trials; improved monitoring and reporting.
For Cancer Center Directors: Coordination among departmental silos; more productive research; alignment with national cancer research enterprise; efficiency.
For patients: Better access to clinical trials; new treatments available in a shorter amount of time; more personalized treatment options. 

## We Are Part of a Larger Community Getting Connected with caBIGTM

**Who is Getting Connected?**
- 43 of 63 NCI Designated Cancer Centers
- 16 of 16 NCI Community Cancer Centers
**What are We Doing to Get Connected?**
- Assess where we are (Self-Assessment)
- Determine where we want to be (Center caBIGTM Goals)
- Develop a plan to get there (Implementation Plan)
- Implement caBIGTM-compatible infrastructure and tools

***We have completed our Self-Assessment, and are now determining our goals and setting a plan for getting there.  This briefing discusses some of the options and choices that face us. ***

## Topic 2: Understanding the Adopt-Adapt Choice

## Setting the Stage: Key Concepts

- To connect with caBIGTM, we need tools (e.g., software applications) that are caBIGTM-compatible – meaning they can interoperate with other caBIGTM tools to achieve the benefits described above.
- We become caBIGTM-compatible when we either _adopt_ a tool from caBIGTM or when we _adapt_ our own tool to be interoperable (and therefore compatible) with other caBIGTM tools.
- In addition to adopting or adapting tools, we will also connect to the caBIGTM infrastructure backbone – called caGrid (or “The Grid”). This is called “establishing a Grid node” (or, “getting on the Grid”).
- Once connected to others through the Grid, we are able to access caBIGTM-compatible tools and data sets at other organizations, and can offer ours to others as appropriate.

## Two Pathways – Adopt or Adapt 

**Adopting** a tool involves installing software applications already created by caBIGTM, integrating them into our workflow, and connecting to caGrid.
**Adapting** a tool involves modifying our existing software applications to be caBIGTM-compatible,  and then connecting to caGrid.

- Interface from Our Tool to the Grid

## Determining Our Best Path

**Determining Our Best Path**

_**Adopting**_** may be best **_**if**_**...**
- caBIGTM tools fulfill our needs in the domains of clinical trials, molecular research, imaging, and/or biospecimen banking
- End users are open to learning new tools and integrating them in their workflow
- Our technical teams are not available or able to build or reengineer software, but we can leverage internal resources to support a software installation effort** **

_**Adapting**_** may be best **_**if**_**...**
- Our existing technology infrastructure and tools meet the needs of the users, and are already integrated into workflows
- Our technical team has software development expertise and experience with the NCI’s vocabulary and data model tools/repositories

***We can choose a hybrid approach**** where we ****adopt**** some of the available caBIGTM applications ****and**** ****adapt**** some or all of our existing applications.*

## A Practical Example:Biospecimens Management

- Biospecimens management is a critical activity in laboratories across research departments and institutions.  While some have existing robust systems for this, others have simple spreadsheets – rarely do these connect with each other.  To support  biospecimens management, caBIGTM offers caTissue...

*caTissue helps improve the way that biospecimens are catalogued, managed, and accessed - making it easier for researchers to obtain a statistically significant number of specimens and related data for experiments.*

**Adopting**** caTissue...**
- Appropriate for those needing a new tool – either because they don’t have one, or because they wish to replace a legacy system
- Adopting will involve installation of caTissue, integration into existing workflows, and migration of legacy data

**Adapting**** an Existing Tool...**
- Appropriate for those wishing to connect with others, but who want to keep their own biospecimens tool, or for whom data migration poses challenges
- Adapting a tool can involve reengineering an existing tool, or developing an interface that connects an existing tool to caTissue for data exchange

## Topic 3: More about Adopt: Using caBIGTM Tools

## What Tools Can We Adopt? 

- To help us _adopt_ caBIGTM tools, caBIGTM offers three tools bundles. “Bundles” are collections of caBIGTM resources organized by use
- Clinical Trials Compatibility Framework
- Life Sciences Distribution
- Data Sharing and Security Framework
- Two of these tool bundles include a variety of software tools that support clinical trials, biospecimen banking, and molecular research. The third bundle addresses data sharing and compatibility policies, procedures, and model documents. This briefing covers Adopting and Adapting the first two tool bundles; additional information of Adopting and Adapting the Data Sharing and Security Framework will be offered separately.
- caBIGTM tools in the bundles are already caBIGTM-compatible.

## Tools Available to Adopt

**Life Sciences ****Distribution **

**Clinical Trials Compatibility Framework**

- C3PR
- PSC
- caAERS
- caXchange
- CTODS
- caGrid

**Data Sharing and ****Security Framework**

- caArray
- caTissue
- caGWAS
- NCIA
- CTODS
- caGrid

- caBIGTM Policies
- Processes and Best Practices
- Model Documents
- Trust Fabric

## Clinical Trials Compatibility Framework

**The caBIGTM Clinical Trials Compatibility Framework is an integrated, stable, and secure collection of interoperable software **_**tools**_** and **_**infrastructure**_** that supports the management of study participant information through the clinical trial lifecycle. **
**The current version of the framework enables tasks such as: **** **
- Screening and registering patients for accrual to clinical trials
- Scheduling and tracking of patient encounters during the course of a study
- Integrating laboratory results with the patient record
- Tracking and managing adverse events
- Capturing, storing, analyzing and routing clinical data in a meaningful manner

## A Look at the Bundle Tools....

**Cancer Adverse Event Reporting System (caAERS) **– Captures and manages reports describing adverse events that occur during clinical trials.
**caXchange **- Facilitates the automatic capture of data from clinical systems and then performs an automatic translation and import to caBIGTM-compatible clinical trials databases.
**Patient Study Calendar (PSC) **- Enables clinical trial managers to schedule and manage treatment and care events for participants in a clinical trial.
**Cancer Central Clinical Participant Registry (C3PR) **- Tracks subject registrations to clinical trials.
**Clinical Trials Object Data System (CTODS) **- Enables storing and sharing of clinical trials data in both identifiable and de-identified form.
**caGrid **- Provides the backbone for data and message exchange across tools.
**Clinical Data Management System (CDMS) Integration **- Enables the exchange of data between the framework tools and a caBIGTM-compatible clinical data management system.

## Life Sciences Distribution

**The Life Sciences Distribution is a set of tools and infrastructure to provide support for interdisciplinary teams engaged in translational cancer research.  It supports:**
- Data capture and analysis.
- Management of biospecimen resources.
- Sharing of data, images and the interchange of experimental results among geographically distributed teams of interdisciplinary investigators.

## A Look at the Bundle Tools....

**caArray **- Microarray data management system that guides annotation and supports the exchange of SNP and microarray gene expression array data.
**caTissue Core** - A biorepository management that supports collecting, processing, and managing biospecimens and associated information.
**Cancer Genome-Wide Association Studies (caGWAS)** - Allows researchers to integrate, query, report, and analyze a variety of data types from multiple sources including microarray, genomic, immunohistochemistry, imaging, and clinical data through a single application.
**National Cancer Imaging Archive (NCIA)** - A searchable repository of *in vivo *cancer images, such as CT, MRI, and Digital X-rays. NCIA also contains annotation files (PDF, image markup) and annotation data provided by a curator. Cancer images are integrated with clinical and genomic data.
**Clinical Trials Object Data System (CTODS)** - Enables storing and sharing of clinical trials data in both identifiable and de-identified form.
**caGrid **- Provides the backbone for data and message exchange across tools.

## Bringing The Tools Together: A Case Study

- A Team of Clinical and Basic Science Investigators from multiple Cancer Centers wish to collaborate to discover new candidate genes involved in breast cancer.
- Subjects need to be selected that fit a rigorous profile: **CTODS** and the **NCIA** are used to search the databases of the multiple Centers to select the patient pool. **caGrid** makes it possible for the databases at multiple institutions to be interconnected for a joint search
**caTissue** makes it possible to determine which subjects have suitable tissue and serum samples to permit genome-wide SNP analyses and gene expression profiles before and after treatments.
**caGWAS** is used to design and execute the SNP-based study.

## Data Sharing and Security Framework

**Connecting with caBIGTM is not just about tools – it’s about sharing or integrating data held within those or other tools.  **
**To support this in a way that protects sponsors, researchers, and patients, the Data Sharing and Security Framework facilitates appropriate data sharing by addressing legal, regulatory, policy, ethical, proprietary, contractual, and socio-cultural issues.**
**When fully developed, the Data Sharing and Security Framework will consist of:**** **
- caBIGTM Policies
- Processes and Best Practices
- Model Documents
- Trust Fabric

## Want to Learn More About caBIGTM Tools? 

**To learn more about tools available for adoption from caBIGTM: **
- _[Getting Connected with caBIGTM Clinical Trials Compatibility Framework ](https://cabig.nci.nih.gov/getting_connected/1_ClinicalTrial_bundle_LOWres.pdf)__(PDF)_
- _[Getting Connected with](https://cabig.nci.nih.gov/getting_connected/2_LifeSciences_bundle_LOWres.pdf)__[ caBIGTM Life Sciences Distribution ](https://cabig.nci.nih.gov/getting_connected/2_LifeSciences_bundle_LOWres.pdf)__(PDF)_
- _[Getting Connected with](https://cabig.nci.nih.gov/getting_connected/3_DataSharing_bundle_LOWres.pdf)__[ caBIGTM Data Sharing and Security Framework ](https://cabig.nci.nih.gov/getting_connected/3_DataSharing_bundle_LOWres.pdf)__(PDF)_
- Tools pages on the caBIGTM website provide a full listing of caBIGTM tools with information to support their use - Visit _[https://cabig.nci.nih.gov/tools/](https://cabig.nci.nih.gov/tools/)_

## Getting Started on Adoption

- We can adopt as many or as few tools in each bundle as we want, based on our existing tools and our identified needs.
- To choose to adopt, we need to engage decision makers and end users to establish how tools might benefit research efforts, how tools might integrate with existing workflows and processes, and how tools can be leveraged across our institution.
- Accessing and installing caBIGTM tools will require technical teams that can install and integrate the tool into our infrastructure.  Most caBIGTM tools require open source supporting software. Some tools will have hosted options, if we don’t want to install them locally.
- Critical factors influencing our adoption decision include:  tool functionality, usability, and implementation logistics (such as data migration from existing legacy systems).  Our Self-Assessment and caBIGTM Capability Report will help support these decisions.

## Topic 4: More about Adapt: Adapting Tools to be caBIGTM-compatible 

## When Is It Best to Adapt?  

- Some departments at our Center already have cancer research tools that are integrated into existing workflows and infrastructure, that exchange data, and that meet the needs of our users.
- We may wish to _adapt_ these tools to become caBIGTM-compatible, so that they can interoperate with other tools – both at our organization, and at others connected to the caGrid infrastructure.
**Adapting our tool to be caBIGTM-compatible will allow us to...**** **
- Access data from other Centers
- Share data with others – both internally and externally
- Access and share data analysis tools and services with others
- Integrate other caBIGTM tools with our compatible tool
- Further extend or modify other caBIGTM tools to connect with ours.

## How Do I Adapt A Tool? Steps to Compatibility

**How Do I Adapt A Tool? ****Steps to Compatibility**

- caBIGTM-compatibility begins with an **Information (or Data) Model**, which represents the interfaces and relationships of a system.
- The information model is then annotated with **Controlled Vocabularies** to establish shared meaning across model components (called “semantic integration”).
- This annotated information model is then converted into **Common Data Elements (CDEs)** that provide the structure (or format) for the data.
- The information model is also used to generate the **Application Programming Interface (API)**: the mechanism by which data are exchanged.

- These four elements are called **compatibility criteria**.  If each is created correctly, we have a caBIGTM-compatible tool.

**NOTE to PRESENTER:**  If you are speaking to a technical audience, you may wish to modify this slide to remove the definition clauses – technical audiences will know what these terms mean.

## Adapting is a Complex Process with Investment Implications

**Investments are required to adapt a tool to become caBIGTM-compatible – the cost depends on the complexity of our tool, and the degree to which a data model already has been defined.  **
**Staffing – **Achieving caBIGTM compatibility requires technical and domain teams.  The technical team may include a mix of application developers, data modelers and curators, and database administrators.  The domain team represents the scientific research realm that the tool supports.
**Tools – **The National Cancer Institute (NCI) provides a set of tools to support the compatibility development process, as well as a controlled vocabulary repository, and a metadata repository. Previous experience with these tools will facilitate the adaptation process – a training curriculum is available to new users.
**We do not have to reengineer an entire tool to become caBIGTM-compatible – there are many alternative approaches. **

## Alternative Approaches toAdapting a Tool

| Option | Operating Scenario | Recommended Solution |
| --- | --- | --- |
| 1 | We have a paper-based system or a homegrown tool that would not be painful to abandon. | ADOPTION OPTION:  Adopt caBIGTM tool, and migrate existing electronic data to new tool.  |
| 2 | We have an existing basic tool that we want to keep.  Examples: Tool built in Access or mySQL database.   | Become caBIGTM-compatible by installing a caBIGTM tool that serves a similar function, and then map our tool to it. We connect from our tool to the Grid through the caBIGTM tool.   |
| 3 | We have existing tools - more complex than a simple database, with separate modules for reporting and storage (e.g., standard reports are a small extract from a larger system).  | Make the existing tool caBIGTM-compatible for standard reports only.  Data generated in required reports would be caBIGTM compatible; the remaining data need not be.  |
| 4 | We have an existing complex informatics tool (like Option 3), but our reporting needs vary greatly, and we would like to have the entire system caBIGTM-compatible for maximum flexibility.  | Make the full tool compatible, by creating an interface that maps the existing tool’s data structures to caBIGTM standards.  This is the highest investment solution, but may provide the greatest payoff. |

## The Five Steps to Compatibility

- There are five steps in developing a caBIGTM-compatible application using NCI’s caCORE Software Development Kit (SDK) – the steps relate to the four compatibility criteria:
- Creating an Information Model
- Performing Semantic Integration (Vocabularies)
- Transforming the Information Model into Metadata (Common Data Elements)
- Generating Code and Messaging Interfaces (API’s)
- Generating a caGrid Interface

**Lesson 5:  Making a Tool caBIGTM-compatible **

**NOTE to PRESENTER:**  If you are speaking to a NON-technical audience, you may wish to delete this slide – if you ARE speaking to technical audience, you may want to use it in place of the “Steps to Compatibility” slide above.

## Getting Started with Adapting a Tool 

- Adapting a tool to be caBIGTM-compatible requires collaboration by both research domain and technical development representatives – this team will set goals and approach.  The _[caBIGTM Compatibility Guidelines](https://cabig.nci.nih.gov/guidelines_documentation)__ describe the compatibility criteria in more depth. _

## Topic 5: Summary and Next Steps

## Summary: How It All Fits Together

**Summary: ****How It All Fits Together**

## Many Options Are Available

| Option | Operating Scenario | Recommended Solution |
| --- | --- | --- |
| ADOPTING |  |  |
| 1 | We have a paper-based system or a homegrown tool that would not be painful to abandon. | Adopt caBIGTM tool or a caBIGTM-compatible vendor tool, and migrate existing electronic data to new tool.  |
| ADAPTING |  |  |
| 2 | We have an existing basic tool that we want to keep.  Examples: Access or mySQL database.   | Become caBIGTM-compatible by installing a caBIGTM tool with a similar function, and then map our tool to it. We connect from our tool to the Grid through the caBIGTM tool.   |
| 3 | We have existing tools - more complex than a simple database, with separate modules for reporting and storage (e.g., standard reports are a small  extract from a larger system).  | Make the existing tool caBIGTM-compatible for standard reports only.  Data generated in required reports would be caBIGTM compatible; the remaining data need not be.  |
| 4 | We have an existing complex informatics tool (like Option 3), but our reporting needs vary greatly, and we would like to have the entire system caBIGTM-compatible for maximum flexibility.  | Make the full database compatible, by creating an interface that maps the existing tool’s data structures to caBIGTM standards.  This is the highest investment solution, but may have the greatest payoff. |

## Determining the Forward Path

**Determining the Forward Path**

**Next Steps:**** **
- Determine target research domains across the institutions for connecting with caBIGTM - driven in part by the kinds of data we are willing and able to share with others who are connecting.  This data sharing should occur across our institution, as well as with others.
- Identify the team that can drive adopt-adapt decisions in those domains across the Center, with the goal of driving meaningful research collaboration across the institution and with others.
- Establish our Center caBIGTM Goals and a path to Implementation.

**Lesson 1: Introduction to caBIGTM **

**Determining our specific path to connect with caBIGTM will require collaboration and involvement by domain decision-makers, end users, technical experts, and policy team members.   Our Cancer Center Director will approve our final plan. **

## Next Steps - Resources

- To send in a specific question about caBIGTM, write to: _[caBIGconnect@cancer.gov](mailto:caBIGconnect@cancer.gov)__  _
- caBIGTM Essentials Training provides more information about both the tools listed here (adopt option), and the compatibility criteria (adapt option) -  _[https://cabig.nci.nih.gov/training/cabigessentials/player.html](https://cabig.nci.nih.gov/training/cabigessentials/player.html)__ __ _
- Tools pages on caBIGTM website provide a full listing of caBIGTM tools – with information to support their use - _[https://cabig.nci.nih.gov/tools/](https://cabig.nci.nih.gov/tools/)__ __ _
- The Learning Management System includes both the caCORE training curriculum and self-paced training modules about tools: _[http://ncicbtraining.nci.nih.gov](http://ncicbtraining.nci.nih.gov/)__  _