Clinical Trial Registration and Results (CTRR) Project Update and Future Use Case… Scott A. Getzin...

Clinical Trial Registration and Results (CTRR) Project Update and Future Use Case…

Scott A. GetzinEli Lilly and Company

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Clinical Trial Registration and Results (CTRR) Project Update and Future Use Case…

2www.diahome.orgDrug Information Association

Discussion Topics

• What is the CTRR project?• Accomplishments and next steps• Testing and Testing Tool• Use Case Discussion• Business Value Review• Key messages


Current CT Registration Environment

Sponsors Registration Auth.

4

Registry

Registry

Registry

Trial

Trial

Trial

Trial

Proposed CT Registration Environment

CTRRHarmonized

Message

Sponsors

www.bridgmodel.org 5

Registration Auth.

Registry

Registry

Registry

Trial

Trial

Trial

Trial

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:Trial type human pharmacology (phase I)Trial type First Administration to HumansTrial type Bioequivalence StudyTrial type OtherTrial type Other specificationTrial Type Therapeutic Exploratory (Phase II)Trial type Therapeutic Confirmatory (Phase III)Trial Type Therapeutic Use (Phase IV)

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)


Mappings

Registry requirement

Data element

Data element definition BRIDG

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)

Class: Study

Attribute: Phase Code

EudraCT v8 Trial Type

Eight different elements:Trial type human pharmacology (phase I)Trial type First Administration to HumansTrial type Bioequivalence StudyTrial type OtherTrial type Other specificationTrial Type Therapeutic Exploratory (Phase II)Trial type Therapeutic Confirmatory (Phase III)Trial Type Therapeutic Use (Phase IV)

Class for all elements: Study

Attribute for phase I: Phase Code

Attributes for all other phases:Proposing addition to BRIDG

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

Class: Study

Attribute: Phase Code


CTRR Integrated Mappings (Excel)


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


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


Discussion Topics



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) 12

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)13

Discussion Topics



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 hands-on experience at a very focused, detailed level to identify potential issues in preparation for eventual implementation of HL7 CTR&R standards for registrations globally.


Testing Methods / Process

Drug Information Association www.diahome.org 16

• Export data from Registry system• Upload data to Test Tool• Transform data to CTRR message format

• Transform CTRR message back to Registry format

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)


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

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



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


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 ** Interactive Use Cases


Discussion Topics



Costs of the CT Registration Environment

Sponsors

30

$200K *

$200K *$200K *

* Estimated Costs

Registration Auth.

Registry

Registry

Registry

Trial

Trial

Trial

Trial

Proposed CT Registration Environment

CTRRHarmonized

Message

Sponsors

31

$200K *

Update Once, Distribute to Many

* Estimated Costs

Registration Auth.

Registry

Registry

Registry

Trial

Trial

Trial

Trial

32

Mandatory for Registrant to

Post(in effect)

Mandatory for Government or

EC to Post++

(in effect)

Mandatory for Registrant to

Post(pending)

Mandatory for Government or

EC to Post(pending)

Legislation / Regulations

(ongoing activity)

Voluntary Registry(in effect)

Austria NIS1

Brazil2

IndiaIsraelMaine3

MalaysiaSouth AfricaTaiwanUnited States

ArgentinaCzech RepublicEuropean Union4

FranceItalyKorea (KFDA)NetherlandsCCMO

NorwayPeruSerbia

Spain Croatia5

European Union6

Germany7

Singapore

AustraliaChinaNew ZealandPolandSwitzerland

AfricaAustraliaBrazilREBEC

ChinaCubaEuropean Union8

GermanyDRKS

Hong KongIranJapanKorea (CRiS)9

LatinRECNetherlandsNTR

New ZealandSri LankaTaiwan PMS10

Tanzania11

ThailandUnited Kingdom12

International Registration Status(used with permission of SEC Associates, Inc.)

© 2011 SEC Associates, Inc.

• This table is not intended to be exhaustive• Last updated Aug 2011

1 Non-interventional studies2 Phase 3 trials in WHO/ICMJE registry3 Effective until 9/28/20114 Interventional (EU CTR)

9 Voluntary status unconfirmed10 Post-marketing studies11 Currently in public user test phase12 NRES, ISRCTN, and PROSPERO

++ Often part of CTA or ethics approval process

5 Transitioning from CT.gov extracts6 Non-interventional post-authorisation safety studies7 Results only8 ENCePP e-Register of Studies

• 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

CTRR Benefit – Value…

33

Discussion Topics



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…


• 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

Looking for More CTRR Project Sponsors…


Contact information

To learn more about participation in the CTRR working team:

Tracy Beck [email protected]

Scott Getzin [email protected]

Sarah Larson [email protected]

And many others…


mailto:[email protected]



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Clinical Trial Registration and Results (CTRR) Project Update and Future Use Case… Scott A. Getzin...

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