1 Achieving efficiency by bringing global business process and technology together through standards Genzyme Structured (Protocol) Authoring Proof‐of‐Concept Pilot BACUN Meeting 20 July 2011 A. Brooke Hinkson, Associate Director, Global Biomedical Informatics, Genzyme Angela M. Horowitz, Manager, Medical Writing, Genzyme S trategic, M easurable, A chievable, R ealistic and T imely Program to achieve efficiencies for clinical information processes
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Achieving efficiency by bringing global business process and technology together through standards
Genzyme Structured (Protocol) Authoring Proof‐of‐Concept Pilot
BACUN Meeting20 July 2011
A. Brooke Hinkson, Associate Director, Global Biomedical Informatics, Genzyme
Angela M. Horowitz, Manager, Medical Writing, Genzyme
Strategic, Measurable, Achievable, Realistic and Timely Program
to achieve efficiencies for clinical information processes
● Walk Through of Structured Documents– Genzyme Structured Protocol Template and Sample Structured Protocols– Opportunities for Automated Reuse Beyond the Protocol
● SCM Summary and Q&A
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Topic-Based SCM Benefits Ensure Quality and
Standards
“Quality by Design”
● Ensure document content presents the right information based on approved business practices and standards
– Enforces standard text and vocabulary that's harmonized with data standards, SOPs and "built-in" best practices
– Automated business rules help to validate the content in each document
Enhance Transparency ● Understand where and when the content has been used, clearly expose key messages and findings
– Allows users to understand the downstream impact of changes to content to other business processes/documents
Reduce Rewriting and Review Time
● Reuse quality content “building blocks” of text, data and figures– Reuse of known, approved content, allows author to focus on new content
● Targeted writing and review tasks – Specific topics assigned based on subject matter expertise
Improve “Findability” ● Search and navigate based on subject matter at the “topic” or “document” level
– Robust metadata on topics enables effective search by subject matter extending far beyond traditional "keyword searches”
Enable Service Providers and Collaboration with Business Partners
● Provide controlled access to document content and supporting content/data
– Business partners get the right information to support their work up front, reduce the number of questions and time spent searching for documents
● Assign parallel writing tasks at the “topic” level to external partners– Topic level writing assignments can be spread over time and
carried out in parallel, at any point the document can be published to see the latest version
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SCM Roadmap – Development (Partial)
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Structured Authoring Proof-of-Concept Goals
● Demonstrate the value and feasibility of implementing topic-based structured content for:
● Provide protocol and CTT requirements for a standards-based centralized metadata management capability (i.e., Metadata Repository [MDR])
● Identify and understand the business process changes needed to perform topic-based structured authoring for clinical protocols and CTT
● Demonstrate automation of protocol content going to other purposes including protocol registration
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Developing a Content Architecture
Begin with an initial topic-based content architecture•A set of Topics defining the content•Metadata describing each Topic
• Artifact, Domain, Content Type, …
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Refine the content architecture by deconstructing legacy documents into their Topics components
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Maintaining a Content Architecture cont…
Establish a governance process to:• Balance the benefit of introducing new content with reuse of standard content
• Ensure quality
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Establish the role of content designer as an expert in application of the content architecture
• Creates initial version of new documents
• Recognizes need for new content
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Topic-Based Content Architecture
Content
Artifact Efficacy Objective
Domain Clinical Study-Objective
Content Type Study Design
Study
Phase Phase 3
Study Design Parallel Group
Control Double blind
Blocks of content such as “Study Objectives”
described by metadata
• “Topics” in the Content Architecture contain reusable content• Metadata describes each Topic based on its subject matter• The metadata is used both to
o Enable search at the “topic level”o Bind Topics to specific kinds of documents
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The Topic Map
• The “Topic Map”references each Topic and defines the content “backbone” of a document
• Topics are bound to the Topic Map based on metadata
Topic
Topic
Topic
Topic
Topic Map
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Publishing Documents From Topics
Reusable Topic PoolReusable Topic Pool Topic MapTopic Map
Metadata RepositoryMetadata Repository
Data and/or Reusable DocumentsData and/or Reusable Documents
As a result, business documents are published in format
As a result, business documents are published in format
Other TopicMaps
Database
• Documents may be published from both topics and previously completed documents• The Topic Map and Publication Metadata* indicate format and where each topic is used• Documents may be published from both topics and previously completed documents• The Topic Map and Publication Metadata* indicate format and where each topic is used
Global Development
Plan
ClinicalProtocol
ClinicalProtocol
SynopsisClinical
TrialRegistration
ClinicalStudy
Report
ClinicalSummaries
Publ
ishi
ngPr
oces
s*
*Publishing integrates Genzyme Style Guide into the document, e.g., font size, margins, etc…
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Key Concept“Document Design PatternDocument Design Pattern”A relationship between topics defining:– a set of topics to be included in the document– the locations for these topics in the document
For example,the “Objectives, Endpoints and Assessments”
design pattern is in the protocol and study report:
Content Design Patterns for Clinical Documentation
Some “Design Patterns” for Clinical Documents
• Derived Topic Guidance• Controlled Topic Terminology• Objectives, Endpoints and
Assessments• Requirement-Event/Finding-
Assessment• State of Subject – Background• Statement of Procedure
Some “Design Patterns” for Clinical Documents
• Derived Topic Guidance• Controlled Topic Terminology• Objectives, Endpoints and
Assessments• Requirement-Event/Finding-
Assessment• State of Subject – Background• Statement of Procedure
1) One TopicMap is published to create One Document1) One TopicMap is published to create One Document
2) Each Topic has a relationship to one or more TopicMaps2) Each Topic has a relationship to one or more TopicMaps
StudyTopic
…
StudyDesignTopic
…
StudyConductTopic
…
ProductTopic
…
4) Sub-class Topics represent specific domains with respect to metadata
4) Sub-class Topics represent specific domains with respect to metadata
3) The “Topic” is the primary unit of reusable content
3) The “Topic” is the primary unit of reusable content
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A Standard Mapping Table (BRIDG PRM)
CORE BRIDG Description Applied ToArtifact: Study Legal Sponsor Title: <name of organization>Property: Name Domain: Clinical Study-Sponsor ContentType: Legal Entity Role: Instance Category: CORE
Class: StudyLegalSponsorAttribute: nameDomain: BRIDG DAM Protocol Representation Sub-Domain
The name of the clinical study sponsor
Property of a Topic
Artifact: Study Legal Sponsor Title: <name of organization>Property: Postal Address Domain: Clinical Study-Sponsor ContentType: Legal Entity Role: Instance Category: CORE
Class: StudyLegalSponsorAttribute: postalAddressDomain: BRIDG DAM Protocol Representation Sub-Domain
The postal address of the clinical study sponsor
Property of a Topic
Artifact: Standard Mapping TableTitle: Genzyme CORE To BRIDG MapDomain: Clinical StudyContentType: ConfigurationRole: InstanceSourceType: Word TableCategory: CORE
• A Standard Mapping Tableo is a Topic with CORE metadatao provides the information needed to translate
from the CORE content architecture to another data standard
• A Standard Mapping Tableo is a Topic with CORE metadatao provides the information needed to translate
from the CORE content architecture to another data standard
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Single Source of Content: Mapped to Multiple Data Standards
Topic(content)
• A single Topic can be represented by metadata from different standards• Each data standard can be thought of as “plugging” into the Topic like spokes on a wheel• A single Topic can be represented by metadata from different standards• Each data standard can be thought of as “plugging” into the Topic like spokes on a wheel
CDISC BRIDG PRMProtocol Representation Model
CDISC ODMOperational Data Model
HL7 CTR&R Clinical Trial Registration & Results Model
Genzyme CORE Content Architecture
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Metadata for Content and Data Alignment
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• Trial Arm(s) or “treatment regimen” are described in the content of the protocol• Content describing the “Placebo” trial arm determines the data in the Trial Arm Dataset• Content metadata for the “Placebo” trial arm aligns with metadata for the Trial Arm Dataset
Standard Attribute Value
Trial Arm Dataset(CDISC SDTM)
STUDYID AB123456
DOMAIN TA (Trial Arm)
ARM Placebo
ELEMENT Placebo
EPOCH Treatment
Attribute ValueArtifact Treatments Administered
Title Study Arm-Placebo
Domain Clinical Study-Dosing
Content Type Study Design
Content Level Metadata
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Metadata for Content and Data Alignment cont...
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• Assessment Topics from Protocol determine Schedule of Study Events• Schedule of Study Events determines clinical data collected (e.g., CRFs)
Attribute ValueArtifact Vital Signs
Title Blood Pressure/Pulse-Standing
Domain Vital Signs and Body Measurements
Content Type Clinical Assessment
Topic Metadata
Clinical ProtocolClinical Content
Objectives
Endpoints
Assessments
Inclusion / ExclusionCriteria
Study phase Screening TreatmentVisit Numbers Visit 1 Visit 2
Week Week -1 Week 2Screen
Inclusion/Exclusion criteria XMedical History XDemography XDosing, AEs and ConMedsDrug administration XSerious Adverse Events As requiredConcomitant meds/Therapies As requiredVital signsBlood pressure / Pulse rate X X
Case Report Form
Domain:
Position:
Diastolic BP:
Systolic BP:
Vital Signs
Standing
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Topic MapTopic MapReusable Topic PoolReusable Topic Pool
ClinicalTrials.gov XML Submission<?xml version="1.0" encoding="UTF-8"?><clinical_study rank="1">
<!-- This xml conforms to: http://clinicaltrials.gov/ct2/html/images/info/public.dtd --><id_info><org_study_id> [Protocol Number]</org_study_id><nct_id>[NCTXXXXXXXXX]</nct_id></id_info><official_title>A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Assess the Safety and Efficacy of Thrice Weekly and Once Weekly Regimens of Mipomersen Sodium in Patients with Familial Hypercholesterolemia</official_title><sponsors><lead_sponsor><agency>Genzyme</agency><agency class>Industry</agency_class></lead_sponsor></sponsors><primary_outcome>
<measure> To compare percent change in LDL-C from Baseline to Week 28/Early Termination (ET represents the observation closest to 2 weeks after last dose among patients who early terminate study medication dosing)
</measure><time_frame>up to 2 years</time_frame><safety_issue>No</safety_issue>
</primary_outcome>
<intervention><intervention_type>Biological</intervention_type><intervention_name>[Name]</intervention_name><description>1 mg/kg, Day 1, Day 28, Day 56, and Day 84 patients will receive a single intravenous (IV)
NOTE: Topics from the protocol can be published into XML such as that for a ClinicalTrials.gov XML submission.
NOTE: The topic map (aka the document) actually provides the context for an Objective or Endpoint being “Primary”, “Secondary” or “Exploratory”.
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Structured Document Walk Through
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Global Protocol Guidance
(PDF file)
• Guidance• Sample text• Example text
Provides authors with by section authoring guidance on protocol content
•Standard text
Mandatory language that reflects Genzyme’s “best practices”
Global Structured Protocol Template –A More Robust Starting Point
Global Protocol Template
Global Structured Protocol Template
(2003 .dot file)
• Standard formatting
Provides Genzyme-specific formatting and styles
+ =+
Content Repository
(.doc files)
• Reusable content
Appropriate protocol content is selected by Content Designer from repository
(2007 .dotm file)
• Guidance• Sample text• Example text• Instruction text• Standard text• Standard formatting
Draft Protocol v0.1
• Draft content
Starting point for protocol authoring
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Draft and Final Publication Filters
A document may be published for different purposes• DRAFT documents are designed to assist the author, reviewer(s) and other
contributors to understand what content should be• FINAL documents are meant for use by a document consumer
Publ
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Output Class
author
consumer
• Contains:• Guidance, Instructions,
Samples, Examples• DRAFT Content• Standard Text• Standard Formatting
• Contains:• Content (DRAFT or FINAL)• Standard Text• Standard Formatting
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Single Source Publishing
• Content published to Word can also be published to XML in a defined format
• The common DITA Topic content can be “published” to Word or other XML formats such as that required for Clinical Trial registration e.g., ClinicalTrials.gov, EudraCT, CTR&R HL7 message