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Reporting and Sharing
Special Interest Group
Christo Andonyadis, D.Sc
Associate Director, Clinical Trials Application Engineering
NCI Center for Biomedical Informatics and Information Technology
andonyac@mail.nih.gov
caBIG™ Clinical Trials Management Systems
Workspace Face-to-Face Meeting
May 30 – 31, 2007
Portland, Oregon
May 2007
Agenda
• Overview of Reporting/Sharing SIG Activities
• Scope, Validation and Feedback
• Adverse Event Reporting and Collection (caAERS)
• Routine Data Exchange (RDX)
• Clinical Trials Database (CTDB)
• Clinical Trials Object Model (CTOM)
• Janus (FDA Repository)
• Requirements Gathering for Data Sharing (after the
break)
2 2
What is the Clinical Trials Management
Systems Workspace Trying to Achieve?
• Facilitate the planning and instantiation of clinical
trials, (and their monitoring of trials once they are
instantiated)
• Facilitate the conduct of clinical trials
• Facilitate the reporting and sharing of clinical trial
data to existing/new destinations,
• Achieve interoperability
• Increase the ability of systems to access and use the
data and functionality of other systems
• Facilitate the integration of new sources and
destinations of data
3 3
Special Interest Groups and Projects
Planning/ Conduct Reporting/
Monitoring Sharing
•Standardized Case
Report Forms
•Investigator and Site •Clinical Trials Database
•Cancer Central Clinical
Credential Repository •Routine Data Exchange
Database (C3D)
•Study Initiation Tool •Clinical Trials Object
•Participant Registry
•Protocol Lifecycle Model (CTOM)
•Laboratory Interface
Tracking •Janus (FDA Repository)
•Financial/Billing
•FIREBIRD •Adverse Event Reporting
•Study Calendar
•DCP/DESK and Collection
•Subject Prescreening
•Clinical Data System
•Vendor Systems
(CDS/CDUS)
Interoperability
•System Interoperability and Harmonization
•Structured Protocol Representation (BRIDG)
•Clinical Trials Interoperability Project
4 4
Clinical Trials Database (CTDB)
URL: https://cabig.nci.nih.gov/workspaces/CTMS/CTWG_Implementat
ion/clinicaltrialsdatabasesig
Status: Clinical Trials Working Group (CTWG) Informatics Initiative
Summary: The initiative will establish a comprehensive community
accessible database that will contain information on all NCI-
supported clinical trials with the ultimate goal of enhancing
cancer trial management and planning through improved
coordination and cooperation across the many institutions
involved in cancer trials. An electronic database containing
complete, up-to-date information (e.g., status, protocol, accrual,
adverse events, toxicity, efficacy) of all cancer clinical trials will
be of benefit to all members of the clinical trials community,
including patients. The consolidated availability and routine
review of data reported from all NCI-funded clinical trials is
essential to the timely recognition and appropriate
dissemination of emerging insights on the safety and efficacy of
new treatments.
5 5
Routine Data Exchange (RDX)
URL: https://cabig.nci.nih.gov/workspaces/CTMS/routine-data-
exchange-sig/
Status: Pilot SIG
Summary: Define the requirements for a regulatory reporting interface
module that will facilitate the submission of clinical trial reports
(e.g., Summary 3 and Summary 4) electronically to NCI’s CDS
(Clinical Data Update System) and the NCI’s Clinical Trial
Monitoring Service (CTMS). This application will capture
relevant data from multiple systems and in multiple formats and
translate them into the required formats. The process will be
automated to improve workflow and minimize manual
operations. Additionally, this module will allow retention of data
that is lost under current reporting mechanisms to facilitate
internal analysis of ongoing studies.
6 6
Clinical Trials Object Model (CTOM)
URL: http://gforge.nci.nih.gov/projects/ctom/
Status: Under development
Summary: CTOM is a UML reference implementation of the BRIDG model,
i.e., a UML model of the clinical trials domain. The classes
identified in CTOM are intended to be instantiations of the
abstract BRIDG classes.
CTOM will enable data from any Clinical Trials Data Management
System (CDMS) or data source to be available to the cancer
research community through Java APIs, and thus will be a
means to enable the broad sharing of clinical trials data from
multiple sources in such a way that data from different sources
are compatible.
The initial test load of CTOM was taken from the CTMS
(Theradex) system.
7 7
Janus (FDA Repository)
URL: http://crix.nci.nih.gov/projects/janus/
Status: Under development
Summary: Janus is a standards-based clinical data repository that utilizes
an open source data model originally created by the Food and
Drug Administration in partnership with IBM.
The Janus repository provides a data collection and analysis
warehouse for clinical trial data submitted for protocols (what
was supposed to happen) as well as clinical outcomes data
(what did happen - events, interventions, etc.).
All of this information is submitted in Investigational New Drug
(IND) applications to the FDA. Depending on the particular trial,
the holder of the IND may be NCI, a pharmaceutical or
biotechnology company, an NCI Cooperative Group or an
academic institution funded by NCI.
8 8
Adverse Event Reporting and Collection
(caAERS)
URL: https://cabig.nci.nih.gov/tools/caAERS
Status: Release 2 currently under development
Summary: A comprehensive set of open source tools centered around the
collection, processing and reporting of information related to
adverse events that occur during the course of a cancer clinical
trial. Specific functionalities include:
• Capture of AEs and Notification Alerts
• Interface to Local Clinical Trial Databases
• Mapping to Vocabularies and Coding Systems
• Report Generation and Submission to External Agencies
9 9
Clinical Data System (CDS/CDUS)
URL: https://cdsweb.nci.nih.gov/cdsweb
Status: Web in production
Protocol Abstract & Analysis/Reporting piloted
Summary: CDS Web is fully in production allowing web submitters to
enter their CDS data for submission to CTEP
The Protocol Abstraction module has been piloted to allow
users to enter non-CTEP protocols for CDS (Complete or
Abbreviated) reporting
The Analysis/Reporting module has been piloted to allow users
to run reports on CDS data
10 10
Clinical Data Flow - TODAY
Today SDTM
CDS Viewer
Web (IBM)
JReview
SDTM
Domain Model
C3D CDS CTOM DB Janus
CTMS
CTEP/Theradex
11 11
Submission Standard
Clinical Data Flow - TOMORROW
Tomorrow SDTM
CDS CTOM Viewer
Web Viewer (IBM)
JReview
CTOM SDTM
Object Model APIs Domain Model
C3D CDS CTOM DB Janus
CTMS
CTEP/Theradex
12 12
Submission Standard
Clinical Data Flow - FUTURE
Future SDTM
CDS CTOM Viewer
JReview Web Viewer (IBM)
CDS CTOM SDTM
Object Model APIs Object Model APIs Domain Model
C3D CTOM DB Janus
CTMS
CTEP/Theradex
13 13
Submission Standard
Requirements Gathering for Clinical Trial Data
Sharing
• Data Sharing in the Reporting/Sharing SIG
• Data Sharing Opportunities and Potential Obstacles,
other DSIC Considerations
• Adverse Event Reporting and Collection (caAERS)
• Clinical Data System (CDS/CDUS)
• Routine Data Exchange (RDX)
• Clinical Trials Database (CTDB)
• Clinical Trials Object Model (CTOM)
• Janus (FDA Repository)
14 14
Adverse Event Reporting and Collection
(caAERS)
Data Adverse event specific data for a defined subject on a defined
stored: study. Based on information provided, the system captures the
severity of the adverse event and provides some workflow for
identifying and capturing decisions necessary for further
reporting.
Shared / Adverse event data.
usefully
shareable
data:
Access caAERS utilizes the NCI Common Security Model (CSM) for
Controls: security. caAERS must be able to authenticate both local users
and external users. Since the domain objects are common to all
tiers, the approach taken in caAERS is to express authorization
policy strictly in terms of the domain objects and the actions
that can be performed on them.
15 15
Clinical Data System (CDS/CDUS)
Data Adverse event specific data for a defined subject on a defined
stored: study. Based on information provided, the system captures the
severity of the adverse event and provides some workflow for
identifying and capturing decisions necessary for further
reporting.
Shared / Protocol administrative data
usefully Patient administrative, demographic and outcome data
shareable
data:
Access caAERS utilizes the NCI Common Security Model (CSM) for
Controls: security. caAERS must be able to authenticate both local
users and external users. Since the domain objects are
common to all tiers, the approach taken in caAERS is to
express authorization policy strictly in terms of the domain
objects and the actions that can be performed on them.
16 16
Routine Data Exchange (RDX)
Data RDX is not an application, just an activity to codify NCI
stored: reporting requirements. Data are defined by NCI and will
probably surface as part of the Clinical Trials Database (CTDB).
Shared / Again, see CTDB.
usefully
shareable
data:
Access Again, see CTDB.
Controls:
17 17
Clinical Trials Database (CTDB)
Data All clinical trials data, both aggregate and raw, required by any
stored: kinds of site-NCI reporting, including NCI sponsor reporting,
Cancer Center Summary 4, etc.
Shared / All of the above.
usefully
shareable
data:
Access To be defined by this SIG.
Controls:
18 18
Clinical Trials Object Model (CTOM)
Data All clinical trials data (note that CTOM may be instantiated as a
stored: database or merely a set or APIs).
Shared / All clinical trials data, usually data from other systems
usefully represented by CTOM.
shareable
data:
Access CTOM access controls should be flexible; requirements will be
Controls: determined by the source and destination systems.
19 19
Janus (FDA Repository)
Data All clinical trials data submitted to FDA for regulatory approval.
stored:
Shared / All of the above; note, however, that much of the data will be
usefully proprietary.
shareable
data:
Access CSM will be used. Assume only FDA will have access to all
Controls: data; other groups only to data that they themselves submitted.
20 20
Privacy/Intellectual Capital Terms &
Conditions Decision Tree – DSIC WS
Decision Tree for Privacy/Intellectual Capital Terms and Conditions
Data/Specimens
IP Value Data Sensitivity IRB/ Institutional Restrictions
(Need for Protection) (Regulatory Status) (Policy/ Consent Limitations) Sponsor Restrictions
(Contract Terms & Conditions)
Examples: is the data subject to a restrictive Do your Institution's or IRB's policies or the applicable Do terms and conditions in any sponsored
Do federal or state law or your institution's
license? Is it related to an invention report informed consent documents explicitly or implicitly agreements prohibit or restrict disclosure
policies prohibit or restrict disclosure?
you have or intend to file with your institution? restrict or permit disclosure (e.g., “no commercial use”)? outside institution or to caGRID?
Explicit Consent
High Classified Research/
Identifiable Data Limitations or
Major Restrictions
Restrictions
Coded/Limited Data Delays or Other
Medium Policy Limitations
Set Moderate Restrictions
De-Identified/
None/Low Generic Registry or
Anonymized Data Set No Restrictions
caGRID Permission
ANY of the following: ANY of the following: ALL of the following:
- high IP value - moderate IP value - no IP value
- high sensitivity data (e.g., PHI) - moderate sensitivity data (e.g., LDS) - low sensitivity data
- significant IRB/consent restrictions - limited institutional or IRB policy - no IRB restrictions
- major sponsor restrictions restrictions - no sponsor restrictions
- moderate sponsor restrictions
21 Bi-Lateral or Multi-Lateral MTA
Standardized Click-Through
Terms and Conditions
“EZ Pass” - General Website Terms of
Use
21
Requirements Gathering for Clinical Trial
Data Sharing
Adverse Event Clinical Routine Clinical Clinical Janus
Reporting and Data Data Trials Trials (FDA
Collection System Exchange Database Object Reposit
(caAERS) (CDS) (RDX) (CTDB) Model ory)
(CTOM)
IP Value (need for
protection)
Data Sensitivity
(Regulatory Status)
IRB or Intellectual
Restrictions (Policy
or Consent
Limitations)
Sponsor
Restrictions
(Contract Terms &
Conditions 22
22
Next Steps
• Summary of discussion points
• Review of Action Items
23 23
Thank you!
24 24
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