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caBIG® POSSCON March 23, 2011

John Speakman Chief Program Officer, CBIIT, NCI

john.speakman@nih.gov @speakman (views mine, not NCI’s)


The National Cancer Institute (NCI): cancer.gov


Why NCI is in the informatics space: 21st Century Biomedicine, all the P’s


How’re we doing? • Estimated US cancer deaths 2009: 562,340 (American Cancer Society)

• Estimated new US cancer cases 2009: 1,479,350 (American Cancer Society)

• Cost of cancer deaths: $960.7 billion in 2000, estimated $1,472.5 billion in 2020 (Journal of the National Cancer Institute, Dec. 9, 2008)


Biomedical Research is Decades Behind the “Knowledge Economy” Curve The cancer Biomedical Informatics Grid® (caBIG®) is a virtual network of interconnected data, individuals, and organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise.


20th Century Research > Care Paradigm

•  Biological pathways 
 •  Target identification and validation

•  Candidate selection and Optimization
 •  Pre-clinical testing
 •  Phase I, II, III
 •  New Drug application and Approval#

•  Product launch

•  Reporting of serious/fatal ADRs

•  Clinical adoption #

•  Re-labeling (or recall) as needed
 •  Additional indications as warranted#



21st Century Learning Health System


Role of private sector •  Ernst & Young, Progressions 2011: •  Pharma 3.0: The health outcomes ecosystem •  Growing pool of data will be generated through electronic health records, social media, online communities, wireless devices and smartphones, “meaning that no single entity will own or control all of the data about any company, product, disease state or patient behavior.” •  “Value will come from developing insightful solutions with the data.” •  Open, defined interfaces mean a “common market” •  Focusing on interfaces, NCI has a core collection of non-viral, open source code (not abandonware) that can be reused


NCI also has an architecture: Services-Aware Interoperability Framework (SAIF) Framework for the development and use of data standards in a Services Oriented Architecture •  •  •  •  •

Human-readable statements about APIs Machine-testable definitions Platform-independent specifications Expanded metadata infrastructure Robust services framework


UTILITY”

“Infra /

“CORE” “CAPABILITY”“PROCESS”

NCI Enterprise sSOA Periodic Table of Services R

Pt

Oc

Po

E

Ae

Hx

Dx

Ds

Ra

Registration

Protocol

Study Outcomes

Patient Outcomes

Eligibility

Adverse Event

Hx and Physical

Discharge Note

Decision Support

Referral and Authorization

Cr

S

Tp

I

L

Rx

Sc

Credentialing

Specimen

Treatment Plan

Image

Lab

Pharmacy

Scheduling

Sd Qr SDTM

Data Query

C

O

P

Pa

D

A

Correlation

Organization

Person

Protocol Abstraction

Disease

Agent

Km Cm Ev Va Tx Au Knowledge Management

Contract Management

Enterprise Vocabulary

Validation

Translation

Audit

Id Id Management

Mp Ay Master Problem List

Tr

11Trust

Management

Allergy

Aa Py Authorization Authentication

Policy


caBIG® Core Principles •  Open Access •  Open Development •  Open Source •  Federation •  Over 70 tools developed


Open Source License for NCI-funded caBIG® Software: Lawyer Talk for “BSD-style, non viral” •

•  •  •  •

•  •  •

Source code, object code and related documentation must be available at no charge to the public with “unlimited rights”, i.e., the rights to disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly in any manner and for any purpose (FAR Section 52.227-14, “Rights in Data – General”). End users have no rights to use NCI-owned trademarks or the names “The National Cancer Institute” or “NCI” to endorse or promote products derived from NCI-funded caBIG® Software. There is no affirmative obligation to distribute or otherwise make available the source code of derivative works. “Non-viral” – no reciprocity requirement for distribution of derivative works (“modifications”) Choice of distribution method for source code of derivative works is an economic decision rather than a contractual term required by NCI. Closed distribution may represent a valid choice depending on the type of software product (applications vs. databases vs. infrastructure). Distribution of NCI-funded caBIG® Software that is bundled, combined, integrated or packaged with components that are licensed under reciprocal open source licenses (e.g., GNU GPL) would subject NCI-funded caBIG™ Software to such provisions, and thus conflict with NCI funding terms. Instead, developers of NCI-funded caBIG® Software that needs such components to function should provide instructions to end users to install those components separately. End user documentation must acknowledge the author. If there is no end user documentation, derivative software product itself must acknowledge the author. Licensee is solely responsible for the consequences of incorporating caBIG™ Software into thirdparty software Comprehensive disclaimer of expressed and implied warranties.


2011 Inflexion point: Scope has increased


2011 Inflexion point: People want to contribute


2011 Inflexion point: Appetite for funding of all software development


What we think we need •  Community •  We need to build and maintain a true open-source development community •  We also need to maintain engagement with the user community (i.e., not just actual/potential developers)

•  Content •  We need to coordination “community” (writ very large) development of software, including extensions to existing caBIG applications and infrastructure

•  Connectivity •  We need to support and guide developers •  We need to review submitted code to ensure consistency with caBIG principles and architecture


Other things we have learned / are learning •  Not everyone who says they need functionality, need functionality •  Maybe an open source community, with sufficient separation from NCI, can serve as a market

•  Not everyone who thinks they can code, can code •  Maybe an open source community can be a nonjudgmental way

•  Making something open source doesn’t necessarily make it cheaper •  But maybe it can make it easier to scale


We’ve been here already


More .org, less .gov


Find us at: • http://cabig.cancer.gov/ - public site • http://cabig.nci.nih.gov/ - community site • john.speakman@nih.gov • @speakman (views mine, not NCI’s)


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