Transcript Presentation Slide Template (DIA)

Clinical Trial Registration
and Results (CTRR)
Project Update and
Future Use Case…
Scott A. Getzin
Eli Lilly and Company
Clinical Trial Registration and Results (CTRR)
Project Update and Future Use Case…
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Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
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3
Current CT Registration Environment
Sponsors
Registration Auth.
Registry
Trial
Trial
Registry
Trial
Registry
4
Trial
Proposed CT Registration Environment
Sponsors
Registration Auth.
Registry
Trial
Trial
CTRR
Harmonized
Message
Registry
Trial
Registry
www.bridgmodel.org
Trial
5
Adapting a term: Phase of Study
Registry
requirement
Data element
Data element definition
Clinicaltrials.gov
Study Phase
Phase of investigation, as defined by the US FDA for
trials involving investigational new drugs. (N/A, Phase 0,
Phase 1, Phase 1/Phase2, Phase 2, Phase 2/Phase 3,
Phase 3, Phase 4)
EudraCT v8
Trial Type
Eight different elements:
WHO
Study Type Phase
Phase of investigation, as defined by the US FDA for
trials involving investigational new drugs. (N/A, Phase 0,
Phase 1, Phase 1/Phase2, Phase 2, Phase 2/Phase 3,
Phase 3, Phase 4)
Drug Information Association
Trial type human pharmacology (phase I)
Trial type First Administration to Humans
Trial type Bioequivalence Study
Trial type Other
Trial type Other specification
Trial Type Therapeutic Exploratory (Phase II)
Trial type Therapeutic Confirmatory (Phase III)
Trial Type Therapeutic Use (Phase IV)
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Mappings
Registry
Data
requirement element
Data element definition
Clinicaltrials.
gov
Study
Phase
Phase of investigation, as defined by the
US FDA for trials involving investigational
new drugs. (N/A, Phase 0, Phase 1, Phase
1/Phase2, Phase 2, Phase 2/Phase 3,
Phase 3, Phase 4)
EudraCT v8
Trial
Type
Eight different elements:
Trial type human pharmacology (phase I)
Trial type First Administration to Humans
Trial type Bioequivalence Study
Trial type Other
Trial type Other specification
Trial Type Therapeutic Exploratory (Phase
BRIDG
Class: Study
Attribute: Phase Code
Class for all elements: Study
Attribute for phase I: Phase Code
Attributes for all other phases:
Proposing addition to BRIDG
II)
Trial type Therapeutic Confirmatory
(Phase III)
Trial Type Therapeutic Use (Phase IV)
WHO
Study
Type Phase
Drug Information Association
Phase of investigation, as defined by the
US FDA for trials involving investigational
new drugs. (N/A, Phase 0, Phase 1, Phase
1/Phase2, Phase 2, Phase 2/Phase 3,
Phase 3, Phase 4
www.diahome.org
Class: Study
Attribute: Phase Code
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CTRR Integrated Mappings (Excel)
Drug Information Association
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Benefits
Data elements that are mapped to harmonized
terminology means that the same information can
be put into multiple registries using one message
• Benefit to patients and medical researchers
– Consistent information globally
• Benefit to Sponsors and Health Authorities
– Efficient use of resource
– Consistent information globally
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Clinical Trials Registration and Results
Project Goals:
• To develop an initial data exchange standard to meet the
current global requirements for trial registration and basic
results reporting
• Utilize the RCRIM BRIDG model in the analysis process
and extend, as needed, to meet trial registry and result
requirements
• To extend the initial trial registration standard to meet the
results reporting requirements as they become known
• Establish a roadmap for evolving the standard into an
ISO approved, global exchange standard
Drug Information Association
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Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
www.diahome.org
11
CTRR Accomplishments
May 2009 – Message Development
• Complete Storyboards, Interaction and Activity
Diagrams, Trigger Events, etc...
• Develop CTRR HL7 Models based on existing
artifacts
January 2010 – Ballot (ClinicalTrials.gov, WHO)
• DSTU Ballot - Draft Standard for Trial Use
(providing all ballot materials including the model)
May 2010 – Ballot (EudraCT v8)
• DSTU Ballot - Draft Standard for Trial Use
(including EMA requirements)
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CTRR Next Steps…
September 2011 – Begin Testing
• Tool Available – signup now!!
• Develop Implementation Guide based on Testing
January 2012 – Extend Message
• Additional Use-Cases
• Results
September 2012 – Ballot
• Normative Ballot (providing all ballot materials
including the implementation guide)
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Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
www.diahome.org
14
Scope of Testing
• The scope of the testing is limited to the
registration of clinical trials to US and EU
registries.
• By limiting the scope, our intent is to gain handson experience at a very focused, detailed level to
identify potential issues in preparation for eventual
implementation of HL7 CTR&R standards for
registrations globally.
Drug Information Association
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Testing Methods / Process
• Export data from Registry system
• Upload data to Test Tool
• Transform data to CTRR message format
• Transform CTRR message back to Registry
format
Drug Information Association
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Testing Scenarios
• Are all fields from ClinicalTrials.gov / EudraCT mapped
correctly to CTRR?
– 1) test if mapping is done correctly by the test system
– 2) verify all mapped fields are valid and held their fidelity (ID
transform) ie. Contact for clinicaltrials.gov has same meaning as
Contact for EudraCT
• Can CTRR map back to ClinicalTrials.gov and EudraCT?
• Can a registry read the CTRR message within the current
process into their own registry? (Initially will be an offline
process)
Drug Information Association
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Testing Assistance
• IntraSphere - Saurabh Aggarwal
– Testing Tool platform
– ClinicalTrials.gov translation to CTRR
message
– Data Viewer of original data and CTRR
• Vertify - Christopher Dedels
– EudraCT translation to CTRR message
– Data Viewer of EudraCT
– Implementation Guide
Drug Information Association
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Login to the test system
Home Screen showing a list of studies
Create new study to enter test data
Import ClinicalTrials.gov Data
Import ClinicalTrials.gov Data for test study
View Imported ClinicalTrials.gov Data
Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
www.diahome.org
25
CTRR Initial Use Cases…
Sponsor  Registration Authority
• Clinical Trial Information Registration Submission
• Update Clinical Trial Information
–
–
–
–
Amendment
Administrative
Recruitment Status
Investigator Status
Registration Authority  2nd Reg. Authority
• Clinical Trial Information Transmission
Drug Information Association
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CTRR Future Use Cases…
Sponsor  Registration Authority
• Request Status Update **
• Clinical Trial – Study Results
Registration Authority  Sponsor
• CT registry Submission Notifications **
–
–
–
–
Acceptance
Rejection
Change Request
Status Update
Drug Information Association
** Interactive Use Cases
www.diahome.org
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Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
www.diahome.org
29
Costs of the CT Registration Environment
Sponsors
Registration Auth.
$200K *
Trial
Registry
$200K *
$200K *
Trial
Registry
Trial
Registry
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Trial
* Estimated Costs
Proposed CT Registration Environment
Sponsors
Registration Auth.
Registry
Trial
Trial
$200K *
CTRR
Harmonized
Message
Registry
Trial
Update Once,
Distribute to Many
Registry
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Trial
* Estimated Costs
International Registration Status
(used with permission of SEC Associates, Inc.)
Mandatory for
Registrant to
Post
(in effect)
Austria NIS1
Brazil2
India
Israel
Maine3
Malaysia
South Africa
Taiwan
United States
Mandatory for
Government or
EC to Post++
(in effect)
Argentina
Czech Republic
European Union4
France
Italy
Korea (KFDA)
NetherlandsCCMO
Norway
Peru
Serbia
Mandatory for
Registrant to
Post
(pending)
Spain
Mandatory for
Government or
EC to Post
(pending)
Croatia5
European Union6
Germany7
Singapore
Legislation /
Regulations
(ongoing
activity)
Australia
China
New Zealand
Poland
Switzerland
++
Often part of CTA or
ethics approval process
•
•
This table is not intended to be exhaustive
Last updated Aug 2011
1
5
9
2
6
10
Non-interventional studies
Phase 3 trials in WHO/ICMJE registry
3 Effective until 9/28/2011
4 Interventional (EU CTR)
Transitioning from CT.gov extracts
Non-interventional post-authorisation safety studies
7 Results only
8 ENCePP e-Register of Studies
© 2011 SEC Associates, Inc.
Voluntary
Registry
(in effect)
Africa
Australia
BrazilREBEC
China
Cuba
European Union8
GermanyDRKS
Hong Kong
Iran
Japan
Korea (CRiS)9
LatinREC
NetherlandsNTR
New Zealand
Sri Lanka
Taiwan PMS10
Tanzania11
Thailand
United Kingdom12
Voluntary status unconfirmed
Post-marketing studies
11 Currently in public user test phase
12 NRES, ISRCTN, and PROSPERO
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CTRR Benefit – Value…
• Consistent Information shared across
Registries minimizing the different fields
meaning and interpretations
• Higher Quality Data due to information only
entered once at the Sponsor system
• Reduced Cost (head count) – Registration Only
– $1 Million per year (estimated)
– Assuming:
• Using a $200K / year estimate to maintain one Registry
• Currently 6 Registries mandate Sponsor registration
• Minimal cost to provide data to the
voluntary registries
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Discussion Topics
•
•
•
•
•
•
What is the CTRR project?
Accomplishments and next steps
Testing and Testing Tool
Use Case Discussion
Business Value Review
Key messages
Drug Information Association
www.diahome.org
34
Key messages
• The industry will continue to be challenged on the
proliferation of trial and result registries
• Harmonization of concepts and terminology are
necessary
• Registration Authorities should look into building a
XML adapter to improve automation
• Registration Authorities should participate in HL7
CTRR working team to contribute to the harmonized
mappings
• Look for Future “Interactive” Use Cases…
Drug Information Association
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Looking for More CTRR Project
Sponsors…
• Sponsors are needed to contribute a fund to pay
for the HL7 modeler.
• Sponsors participate on the CTRR Leadership
Team (monthly)
• Past Sponsors:
–
–
–
–
–
–
Genzyme
Lilly
GSK
Novartis
Merck
Sanofi-Aventis
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Contact information
To learn more about participation in the CTRR working team:
Tracy Beck
Scott Getzin
Sarah Larson
[email protected]
[email protected]
[email protected]
And many others…
Drug Information Association
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