Introduction to the Clinical Development Design (CDD) Framework - - PowerPoint PPT Presentation

Introduction to the Clinical Development Design (CDD) Framework

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The views and opinions expressed in this presentation are solely those of the presenter and author and do not necessarily state or reflect those of AstraZeneca, or any other company.

Presented by the PhUSE CS Semantic Technology “Representing CPD in RDF” Project

Presentation Outline

• CDD Team
• History of the Program
• Original Plan: Structured Information Model
• Stepped Back: Completed the PhUSE Deliverable

Template

• Overview, Purpose, Scope
• Definitions
• Problem Statement
• Recommendations
• DREAMING

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CDD Team

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Team Member (Affiliation) Team Member (Affiliation) Mary Banach (Vanderbilt) Matt Austin (Amgen) Tarek Elbeik (Elbeik Associates) Asiyah Yu Lin (FDA) Maria Benjegard (AstraZeneca) Kerstin Forsberg (AstraZeneca) Hon Sum Ko (FDA) Dale Plummer (Vanderbilt) Steven Hirschfeld (USUHS) Johan Proeve (CDM Consulting) Ian Fisher (Quintiles) Stephen Wilson (FDA) Mitra Rocca (FDA) Laszlo Vasko (AstraZeneca) Rashedul Hasan (FDA)

Smart Program Design Information Model

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Program Design

Endpoint 3 Value Claim Efficacy Claim Safety Claim Objective 1 Objective 2 Objective 3 Endpoint 1 Endpoint 2 Assess ments Assessment Compar ators Location Population Patienopul ation Patient Population Treatment Study Prototype Study Prototype Program Option Trial Prototype Trial Prototype Program Option Comparator Trial Specification Trial Specification Endpoint 3 Assess ments Design

Program Level Design Elements Interpretation of Results Trial/Protocol Level Design Elements Input into design

• f next phase

Vasko L, Sundgren M, Bachmann P, et al. Smart Program Design Through a Common Information Model. Therapeutic Innovation & Regulatory Science: DIA/Sage; 2014.

Development Program Design Structured Information Model

A common information model for clinical program designs: § Enable re-use of internal & publically available information § Reference & link agency guidance to design decision § Build best practice within companies and across industry § Facilitate information sharing between all stakeholders § Enable creative / collaborative tools focusing on improving the quality of clinical development programs and trial designs

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Endpoint 3 Value Claim Efficacy Claim Safety Claim Objective 1 Objective 2 Objective 3 Endpoint 1 Endpoint 2 Assessment Compa rators Location Populatio n Patienop ulation Patient Population Treatment Study Prototyp e Trial Prototype Comparator Endpoint 3 Asses sment s Design

PRM SDTM Harmonized Standards CDASH

Agency Guidance Reference Publications Sources

PhUSE Deliverable Template

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Overview, Purpose, Scope

Overview: The Clinical Development Design (CDD) Framework aims to provide structure and rigor to the design of clinical development programs and to improve design decision making. Purpose: Delivering a plan for capturing structured design thinking in clinical research. Scope: Providing structure and rigor to the design process in clinical research – beginning with the language, terms, and vocabulary of the CDD.

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CDD Framework Definitions

• Design and Decision Making Terms
• CDD-Specific Terms
• Sources for Data to Construct our Database
• Information Modeling Tools
• Semantic Technology Terms

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Problem Statement

The CDD Framework aims to provide a defined structure with:

• Data and links between the data
• Design decision assumptions: constraints and supportive

data

• Cross-industry information model and terminology

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Recommendations

Build a CDD Ontology – database of terms that can then be used for modeling.

§ Download the data from the sources mentioned above into our CDD REDCap database § Build links and determine redundancies § Determine an agreed upon definition for each of the terms. THEN: We can make Cmaps, use Neo4j, and build a semantic technology base for the CDD.

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DREAMING NEXT STEPS

With a vocabulary we can build Cmaps as Rashedul Hasan has done here for Regs2RDF:

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DREAMING NEXT, NEXT STEPS

• With a vocabulary we can use Neo4j for showing the

relationships between work products as Maria Benjegard and Kerstin Forsberg have done here for the Design to Deliver Guide:

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Please Join Us

• Need reviewers for vocabulary.
• Need help with definitions and terminology.
• Need help with links and understanding

redundancies.

• Contact: mary.banach@vanderbilt.edu

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