Download Hepatitis C Project Charter

Project Charter
Name of Project: HEP
C Therapeutic Area Data Standards
March 20th 2014
Project Manager: John Owen (Johnson and Johnson)
1.
Project Team Members
Team members currently identified are listed in a separate roster, which will be maintained in the CDISC Portal,
to accommodate changes over time.
2.
Estimated Number of Active Project Team Members
Team members fall into five groups with different kinds of participation roles in the project. Two of the groups
(core team members and consultants) generally participate in the work of multiple therapeutic area projects.
Consultants are called in as needed, so require a lesser time commitment. Two other groups (TA team members
and reviewers) are recruited for the particular therapeutic area project. Reviewers participate in review of
deliverables at the end of each stage. Finally, members of existing standards teams will serve as liaisons to the
project. An individual may fulfill roles in more than one group.
Group
Core team
TA team
TA reviewers
Standards team liaisons
Number of
Participants
7
9
30 confirmed
20 not confirmed
6
Note that both program level and project level support will be needed for the life of the TA Standards
Development Program as envisioned by the CFAST committee. See the HEP C project team roster for details.
3.
Document Repository Location
Project documents will be maintained in a HEP C TA project area in the CDISC portal accessible to all team
members using the following link
http://cdiscportal.digitalinfuzion.com/Teams%20Projects/Disease-Specialty/Hepatitis_C
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4.
Key Sponsors and Participants:
Current key participants are shown below. The project also intends to invite participation of relevant medical
associations. Other key participants will be added as they are identified.
Stakeholder/Participant
Role
CFAST Therapeutic Area Standards Steering
Committee
Program governance and resource allocation.
Program team members and consultants (includes both
CDISC employees and volunteers).
Provides project management, clinical expertise, team
members and reviewers recruited through member
companies.
Performs review of draft and final documents to ensure data
points meet FDA reviewer needs.
Provides team members and consultants to support
controlled terminology development.
Project liaisons to support the TA standards development
resources.
CDISC
TransCelerate BioPharma
FDA
NCI EVS
CDISC Teams: BRIDG, CDASH, SDS,
Terminology and ADaM
5.
Team/Project Description/Scope
The HEP C therapeutic area standards project is being performed under the CFAST initiative to accelerate clinical
research and medical product development by facilitating the creation and maintenance of data standards, tools,
and methods for conducting research in therapeutic areas important to public health.
The project is scoped to achieve its deliverables within a time frame of 10 months as agreed by CFAST.
The project scope will include data to support endpoints for clinical studies in support of drugs for HEP C in the
following population: Adults , Hepatitis C infection, Genotypes 1-6 in the out-patient setting.
Type of Data
Medical History
Magnitude
HCV Disease History
3 concepts
Family history of interest
4 concepts
Medical History
23 concepts
Prior treatment History
2 concepts
Previous Treatment and outcome
Substance Use
4 concepts
- Recreational Drugs
- Nicotine
- Alcohol
- Diet
Gap Analysis
Development of standards and controlled
terminology (CT) for mode of infection and
historical date data
Existing AP standards may cover the concepts
in this category – further investigation during
stage 1 will be done to confirm if additional
controlled terminology is required for use in a
APMH/SQAPMH
Existing standards should cover the concepts
in this category – many of these concepts are
also important for Inclusion/Exclusion criteria
Data on prior therapies covered by existing
standards
Some development of standards to cover prior
treatment outcome.
Current standards for Substance use will
handle the majority of the data – some
development may be required for specifics on
diet change and alcohol dependency
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Complications of interest
2 categories of treatment related
complications and disease related
complications
Physical Examination
General physical examination
Lab tests, biomarkers and
microscopic tests
Viral Genotyping
46 labs
HCV RNA testing
2 concepts
Assessment and Staging of the
chronic liver disease and
Progression of the liver disease –
including history and on-study
- Non-invasive methods of evaluating/staging
disease
3 concepts
3 concepts
- Invasive Methods of evaluating/staging
disease (Biopsy)
1 concept
- Evaluation of liver disease
(CT/MRI/Ultrasound)
3 concepts
Adverse events of special interest
Medications of special interest
Healthcare Resource Utilization
Will need to assess those that are related to
study drug and those that are related to
disease and determine if the study drug
related complications are relevant for the
TAUG (i.e. applicable to a class of drugs as
opposed to individual drugs)
Data already handled in AE, Lab and
Inclusion/Exclusion
Will assess those that are related to study drug
and those that are related to disease and
determine if the study drug related
complications are relevant for the TAUG (i.e.
applicable to a class of drugs as opposed to
individual drugs)
Further investigation will be carried for some
special classes of physical examination e.g.
compound-specific Rash reaction that may
require more data collection than can be
handled by the existing domains otherwise the
TAUG will follow CDASH guidelines of
recording in Medical History or Adverse
Events
Can be handled with current Lab standards
“Viral genotype” is used to refer to
classification of viral into one of several types
(e.g., GT4 in Egypt), rather than to detailed
sequencing of the virus. The proposed PGx
modelling handles human, animal and
pathogen genomics – further investigation
into the use of LB will be done.
Various assays would be handled as methods
or devices.
“Viral phenotype” refers to resistance,
covered in Virology TAUG.
Can be handled in current lab standards
although there may be some CT development
required
Development of Limit of Detection concept
required
Development of Analysis standards will be
investigated to cover analysis endpoint
concepts such as SVR, Relapse and eRVR for
example.
Serum assessment covered in existing Lab
and Device domains.
Development of GI domain for Fibroscan
concept
Development required for scoring of liver
disease with the various methodologies:
measurement of liver fibrosis, (fibrosis scores
F0-F4/F6), assessment of severity of the liver
disease Child Pugh, MELD (Model for End
stage Liver Disease)
Covered by current standards but may require
development of some CT for various staging
methodologies
Will need to investigate the need for detailed
biopsy results that may require development
of several histopathology concepts.
Also same comment applies as stated in noninvasive methods Development required for
scoring of liver disease with the various
methodologies
Some development required for specific HCC
criteria and diagnosis/monitoring
Will be covered in existing AE standards
Will be covered in existing CM standards
Covered by existing HO standards
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Patient Reported Outcomes
12 questionnaires
Will be handled in the standard QS process
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6.
References
References consulted included relevant NIH, FDA and EMEA guidance, literature and CDEs. A complete list of
references can be found on the CDISC HEP C team portal.
http://cdiscportal.digitalinfuzion.com/Teams%20Projects/DiseaseSpecialty/Hepatitis_C/Working%20Documents/Forms/AllItems.aspx?RootFolder=%2FTeams%20Projects%2FDisease%2DSpecialty%2F
Hepatitis%5FC%2FWorking%20Documents%2FHEP%2DC%20Regulatory%20Guidances%20and%20Scientific%20References&Folder
CTID=0x0120009D801EF6030070459B49412A10E1CBF9&View={D481D062-2F0D-4848-8C86-8D0C0C4F0E64}
7.
Project Deliverables
Project deliverables will include:
 Mind map/concept map of disease area clinical concepts
 Essential core data elements with definitions, data types (simple & ISO 21090), BRIDG and SDTM
mappings
 User/Implementation Guide
 SDTM-based domains and examples, as appropriate
 Minimum value sets (code lists) with definitions and C-Codes, as appropriate
 Statements of permission to publish controlled terminology for copyrighted questionnaires, where
applicable.
The project team will also explore the inclusion of annotated CRFs (with CDASH and SDTM-based annotations)
and ADaM analyses and examples during the course of the project.
Project deliverables will reference sources and describe provenance used in their creation (such as the use of preexisting standards).
8.
Sub teams/Roles
The project team will use the standard TA roles described in the TA Role Definition document. This document
can be found on the CDISC team portal.
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9.
Project Goals/Deliverables/Milestones with Target Dates 2014
The project will follow the enhanced therapeutic area standards development process. Following is high-level
project plan.
Project
Stage
Process Phase
Timeline
End date
Start of HEP C Project
(team formation)
Nov-2013
Stage 1
Complete Identification of Concepts
Q1-2014
Stage 2
Draft HEP C Guide with Definitions
Q2-2014
Public Review
Q3-2014
Publish HEP C User Guide v1.0
Q3-2014
Stage 3
More detailed dates and milestones will be maintained in a separate HEP C project plan.
http://cdiscportal.digitalinfuzion.com/Teams%20Projects/DiseaseSpecialty/Hepatitis_C/Working%20Documents/Forms/AllItems.aspx?RootFolder=%2FTeams%20Projects%2FDisease%2DSpecialty%2F
Hepatitis%5FC%2FWorking%20Documents%2FProject%20Plan&FolderCTID=0x0120009D801EF6030070459B49412A10E1CBF9&Vi
ew={D481D062-2F0D-4848-8C86-8D0C0C4F0E64}
10.
Project Resources, Gaps and Risks
 A major potential risk to this ambitious project plan is project resource availability. For this project to
succeed, assigned resource must continue be made available to work on project deliverables. It is critical that
personnel assigned are able to prioritize the project above other responsibilities.
 This project remains dependent, to a large extent, on volunteer engagement beyond the resources assigned by
TransCelerate BioPharma Inc. (TCB).
 Complexity Assessment
Medium complexity
Rationale:o Most required development is for disease-specific tests, an area for which standards development is
generally well understood.
o Viral resistance data will need to be handled in a manner that is as consistent as possible with the
TAUG-Virology, but recognizing that parts of the TAUG-Virology may soon be superseded by the
SDTMIG-PGx, which is still under development.
o Representation of viral and human genetic data will need to be coordinated with the SDTMIG-PGx
team.
 Proposed v2 Content and Rationale
o During Stage 0 it was discussed about the inclusion of pediatrics into the TAUG. None of the
companies surveyed reported any pediatric studies therefore the decision was taken to focus V1 on
Adult populations. The inclusion of pediatrics may be considered for later versions of the TAUG
o Coordination with the CDISC ADaM foundational team has been made, however, due to the timelines
of this project ADaM inclusion may be deferred to V2 – as we develop the SDTM standards there
may not be sufficient time to include all of the ADaM requirements in V1
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o
o
11.
12.
Due to the amount of Scientific Research and new advances in treatment currently ongoing within the
industry, newer outcomes may be deferred to later versions of the TAUG
Certain endpoints that relate to particular classes of drugs require more thorough investigation (for
example Rash determination). If these endpoints are not considered relevant at this point for an
industry standard we may decide to include this in later releases as more drugs in that class are
developed by a wider array of sponsors.
Related Documents
o The HEP C Team Member Roster (to be updated as required throughout the project)
o
The HEP C Scoping & Input Concepts Listing (Excel)
o
The HEP C Scoping & Input Checklist
o
The HEP C Project Plan
Date Approved: 6th March 2014