A Case Study in Structuring Clinical Content and …...6 SAP Protocol Title Study Rationale Sample Size Protocol CSR Reused As Is Reuse As Is Editable Reuse Editable Reuse Editable

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A Case Study in Structuring Clinical Content and

Structured Content Management (SCM)

TK Booker Porter

Senior Director, Global Medical Writing, Greenwich Biosciences

Martha Cruz Naranjo

Strategic Development Director, Amgen Inc

Angela Horowitz

Practice Lead, Structured Content Management, ArborSys Group

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The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated.

These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.

Disclaimer – Content Slide

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Agenda

Why Structured Content Management (SCM)?

First Attempts at SCM

Interim Approach with SMART Templates

Back to SCM

Q&A

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History of SCM at Amgen

2012-2013

• Identified need for structured content

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Project Team

PD/CMC Nonclinical / Statistical Analysis

Clinical Pharm. /

Statistical Analysis

Clinical / Statistical Analysis

Summary Document

Labeling Responses to Queries

(RTQs)

Medical Affairs

Marketing

Target Product Profile;

Project Plan

Dossier

Investigator’s Brochure

Pharmaceutical Class

PK Reports

M2 Summaries; ISS/ISE

Safety Studies;

Mechanism

of Action

Protocols; SAPs; CSRs

Publications; Phase 4

Protocols

Information Flow Across the Clinical Lifecycle

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SAP

Protocol

Title

Study

Rationale

Sample

Size

Protocol CSR

Reused As Is Reuse As Is

Editable Reuse

Editable Reuse Editable Reuse

Study

Design

Editable Reuse

Editable Reuse

Detailed Information Flow Example

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1. Create Document

from Template

2. Compile Content:

Copy/Paste

3. Write New

Content

4. Review & QC

5. Document Finishing

6. Document Approval

Challenges:

• Formatting and structure rules within

template can be corrupted, causing

downstream issues with publishing

Challenges:

• Single document authored by

multiple authors

• Concurrent authoring of sections not

easily managed

• Edits to previously approved content

are not controlled

Challenges:

• Manually intensive copy/paste

processes which introduce quality

errors

• Authors burdened with locating

approved content

Challenges:

• Manually intensive to fix

formatting issues and confirm

appropriate template used

Day-in-life: Document-centric Process

Challenges:

• Manually intensive processes to

incorporate review feedback

• Re-QC of previously approved content

Challenges:

• Relationship to source

now lost

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What is Structured Content?

• Content that has been analyzed and

decomposed into smaller “chunks” or

components such as: Sections

Paragraphs

Sentences

Tables

Graphics...

• Components are… Classified by their characteristics and

behavior (metadata)

Created, managed, rearranged, and reused

independently

• Documents are constructed from

components

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1. Initial ‘Document’

Creation

2. Compile Content:

Reuse

3. Write New

Content

4. Review & QC

5. Document Finishing

6. Document Approval

Improvements & Value:

• Improved quality and consistency

• Concurrent authoring is supported

across components

• Content can be written for multiple

audiences

• New content is now available for reuse

in other documents


• ‘Document’ (project) outline created,

metadata incorporated

• Standard content/components are auto-

populated from libraries


• Standard or prescribed content/

components incorporated as

needed

• Reduced manual steps to find and

add approved content

• Improved quality and consistency


• Systematic application of

redactions etc. to output


• More efficient review and

commenting process: focus on

changes only, increased collaboration

• Reduced QC reviews

Day-in-life: SCM-centric Process


• Relationship to source

maintained at component

level

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2012-2013


• Defined SCM vision • Identified SCM value for multiple functions

• Performed extensive vendor assessment

2014-2016

• 2014: Selected initial SCM vendor

• 2015: Initiated POC for labeling and clinical

• Early 2016: Canceled POC due to success criteria not met

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Developed SCM Business Case & Roadmap

Identified potential opportunities across enterprise

– Interviewed different functional groups

• Identified documents with content reuse

• Estimated time savings with an automated solution

Evaluated readiness for implementation

– Decided on a rolling implementation

– Agreed to focus on Labeling and Clinical initially

Defined requirements

– Identified key ones to test during a proof-of-concept

(POC) trial

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Key Requirements

Ability to generate and author documents

Ability to easily find and reuse existing content

Retain full traceability/lineage of content

Ability to prepopulate document with relevant content before

authoring

Maintain instructional text separate from document template

Create and govern libraries of standardized or suggested

content

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Initial POC

Performed SCM vendor

assessment and initial selection

Conducted POC in stages

Outcomes:

– Key requirements not met

– Canceled POC

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2012-2013




2014-2016




2016

• Decided to move forward with interim approach

• Initiated SMART template development

2017

• Early 2017: Released SMART templates for clinical

• Continued surveillance of SCM landscape

• Fall 2017: Reengaged efforts for full SCM tool

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Interim Solution: SMART Templates

Evaluated technology-enabled Common Protocol Template

(CPT) provided by TransCelerate Biopharma, Inc.

Decided to implement the CPT, but with extensions to support

multiple document types and enable reuse

– Agreed to limit scope to protocol, SAP and CSR

First step towards SCM

– One-way directional flow of content with no

supporting database…

– Therefore, could not realize full benefits of SCM,

so considered an interim step

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Initial Steps to Structuring Content

Gathered small team of dedicated SMEs to work with business analyst to:

– Map flow of content

– Identify separate library content and instructional text

With this approach, we:

– Identified each piece of content and where it is reused downstream

– Developed model that described content and how it would be (re-)used

– Started developing change management and best practices for authoring content

SAP Protocol CSR

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SMART Templates Implementation

Protocol CSR

SMART Templates

xml file

on desktop

Export Import

Built SMART templates with

xml backbone

– Enabled content to be exported

and imported from

1 document to another

– Content is automatically

inserted into predefined section

via metadata tagging

Managed library content and

instructional text in a central

location

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New Possibility

Continued surveillance of SCM market

A subsequent SCM platform was identified

Decided to reengage by starting a new POC

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2012-2013




2014-2016




2016

• Decided to move forward with interim approach

• Initiated SMART template development

2017

• Early 2017: Released SMART templates for clinical

• Continued surveillance of SCM landscape

• Fall 2017: Reengaged efforts for full SCM tool

2018

• Selected 2nd SCM vendor • Conducted POC to assess functionalities critical for pharma

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copy/

paste

Content Reuse Progression

Protocol CSR

Protocol CSR

Traditional Method SMART Templates Structured Content Management

Previously written content

Standardized library content

Database Protocol CSR

System Integrations

XML file

to desktop

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POC Pre-planning

Built team

– Included business SMEs from clinical and labeling

– Include IS team members

Revisited and refined SCM requirements

– Focused on key requirements spanning all business areas

– Prioritized requirements to define POC scope

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POC Pre-planning Cont.

Developed user stories and acceptance criteria

– User story: As an author, I want to create a document using content

from an existing document (eg, create SAP from protocol), so that I

can more efficiently and consistently create documents that conform to

company standards

– Acceptance Criteria: Given an author is creating a document that uses

content from an existing document, when the user selects an existing

document (eg, protocol), then the system will populate all components

from the existing document into the new document (eg, SAP) as

defined in the info model

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Functional Capabilities Assessed in POC

• Author document

• Reuse content from other documents

• Reuse content from library

• Save & check-in document

• Send document for review

Author

Approve Document

Incorporate Review

Comments

Review Document

Author Document

• Generate a new document

(eg, protocol)

• Generate a new document from

1 or more base documents (eg,

CSR from protocol & SAP)

Author

Generate Document

• Receive review notification

• Review document and

incorporate comments

• Complete review task with

comments, if needed

Reviewer(s)

• Address reviewer comments

• Send document for approval

Author

• Receive approval

notification

• Review document

• Approve or Reject, with

comments if needed

Additional functionalities:

• Client can configure much of system

• Client can configure their templates

• Bulk import/export content and metadata

• Versioning of documents and components

• Clear visibility of full content lineage

• Generation of summary of changes table

• Audit history

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Sprint 1 Sprint 2 Sprint 3 Sprint 4 Sprint 5 Sprint 6 Sprint 7 Sprint 8

Execution of POC

Sprint Planning

• Confirm sprint’s scope

• Discuss detailed requirements

Sprint Execution

• Complete development work and configurations

• Deliver mid-point demo (if needed)

Sprint Review/Demo

• Deliver final sprint demo

• Conduct retrospective

POC conducted in sprints

Each functional capability allocated to a sprint

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SCM POC Outcome

• Author document

• Reuse content from other documents

• Reuse content from library

• Save & check-in document

• Send document for review

Author

Approve Document

Incorporate Review

Comments

Review Document

Author Document

• Generate a new document

(eg, protocol)

• Generate a new document from

1 or more base documents (eg,

CSR from protocol & SAP)

Author

Generate Document

• Receive review notification

• Review document and

incorporate comments

• Complete review task with

comments, if needed

Reviewer(s)

• Address reviewer comments

• Send document for approval

Author

• Receive approval

notification

• Review document

• Approve or Reject, with

comments if needed

Additional functionalities:

• Client can configure much of system

• Client can configure their templates

• Bulk import/export content and metadata

• Versioning of documents and components

• Clear visibility of full content lineage

• Generation of summary of changes table

• Audit history

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• Key requirements met or

exceeded

• Additional enhancements

would be available in near

term

POC Conclusions & Recommendation

POC Production Pilot Implementation

• Develop implementation plan

• Plan integrations to key

systems

• Test additional enhancements

*Recommendation*

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TK Booker Porter

Senior Director, Global Medical Writing, Greenwich Biosciences

Martha Cruz Naranjo

Strategic Development Director, Amgen Inc

Angela Horowitz

Practice Lead, Structured Content Management, ArborSys Group

Join the conversation #DIA2019

Thank You

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Backup Slides

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Challenges:

• Manual copy/paste

• Difficulty finding specific content to reuse

• No traceability of where content is reused

• No systematic process for reuse

Leads to:

• Inconsistency

• Potential compliance risks

• Increased labor and costly authoring process

• Longer cycle times

• Inability to track what was submitted

Protocol CSR SAP

Traditional Document-Based Authoring

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

copy/paste

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and how that information

can be reused in

subsequent documents

Results in:

• Quality through consistency

• Enhanced flexibility, speed,

& productivity

• Lower risk of errors &

regulatory/compliance

issues

What is Structured Content Authoring (SCA)?

Instead of thinking

about a document…

think about pieces of

information (or content)

that make up a document…

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With component-based authoring you get:

• Superior search and retrieval

• Rules-based reuse

• Traceability

• Consistency

• Reduced compliance risk

• Shorter cycle times (no need for re-review/

re-QC of reused content)

• Reduced labor and cost savings

• Core dossier content can be easily adapted to

regional-specific instances

• Clear view of what was submitted

New

Comps.

Reused

New

Comps.

SAP Protocol CSR

Component Repository

A Paradigm Shift to SCA