Định nghĩa chuẩn CDISC trong thử nghiệm lâm sàng

Want to save lives, improve quality of life Must be able to share data to, e.g., replicate results, access larger pools of data… BUT… it’s useless if the data aren’t fit for intended use

© CDISC 2016

An Overview of CDISC :

A Clinical Data Standards Organization

Kit Howard, MS, CCDM, CRCP

CDISC, Director of Education

Co-Leader Medical Device Standards Development

Michael Ibara

CDISC, Head of Digital Healthcare

MDEpiNet Webinar, 17-Jun-2016

Agenda

• Part 1 - Kit

 Introduce CDISC and its clinical standards

 Where do CDISC standards fit into the larger picture of standards

 Opportunities to leverage CDISC in MDEpiNet projects

• Part 2 - Michael

 Describe CDISC’s eSource initiative

 Introduce topic area challenges and

opportunities

Develops open and free data standards for

clinical research

Funders Regulatory Agencies Publishers

Funders Regulatory Agencies Publishers

Editorials

Nature 522, (10 june 2015)

The Public

Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC)

Healthcare data, Repository Data, Research Data…

For what? Pool, compare, reanalyze, repurpose,

hypothesize, reinterpret, fish…

Pressure to Share Data is Intense:

Funders Regulatory Agencies Publishers

Editorials

Nature 522, (10 june 2015)

The Public

Healthcare data, Repository Data, Research Data…

For what? Pool, compare, reanalyze, repurpose,

hypothesize, reinterpret, fish…

Pressure to Share Data is Intense:

© CDISC 2016

What do we want to do?

Want to save lives, improve quality of life

Must be able to share data to, e.g., replicate results, access larger pools of data…

BUT… it’s useless if the data aren’t fit for intended uses

Clinical research data standards are part of solution

CDISC Can Help…

• Core clinical data

• Therapeutic area data

• Device data including

• Pre-market UDI analogue

• Design to capture “in-use” settings

Defined data structures optimized for research and

designed for pooling

Also supports data repository structures to pool

repositories and pool with clinical research data

Understands HL-7 via ISO-approved BRIDG

Streamlines FDA submission production

© CDISC 2016

What is a Clinical Research Data Standard?

A set of defined data elements, their characteristics and

relationships among them

Rules for creating, managing and using the data

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

MDIC

HITSP

ICH

ANSI CEN

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

HITSP

ICH

ANSI CEN

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

HITSP

ICH

ANSI CEN

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

HITSP

ICH

ANSI CEN

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

HITSP

FDA ICH

ANSI CEN

TransCelerate

NCVHS

PHIN UMLS

JIC ONC

MDIC

HITSP

Typical Data Flow in Clinical Research

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

CDISC’s Foundational Standards Can Help

21

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

Michael’s talk in Part 2

CDISC’s Foundational Standards Can Help

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

CDISC Standards: Protocol

Protocol Representation Model (PRM)

Machine-readable study design;

e.g., allows comparison of outcomes across study designs

CDISC’s Foundational Standards Can Help

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

CDISC Standards: Data Collection

CDISC Standards: Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

CDASH SDTM

Healthcare

Systems

SDTM

Example Reporting Data

CDISC Standards: Study Datasets/ Reporting

Data Comes from CDASH

Example Reporting Data

CDISC Standards: Study Datasets/ Reporting

Example Reporting Data

CDISC Standards: Study Datasets/ Reporting

Data Comes from CDASH

CDISC’s Foundational Standards Can Help

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

CDISC Standards: Analysis Datasets

CDISC’s Foundational Standards Can Help

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

Use the Same Answer Set

Use the Same Name

Save in the Same Structure

How do we know if data are the same?

Use Same Assumptions

Assuming you ask a valid question…

Foundational (Core) Standards Cover

Interventions Events Findings Special Purpose

Concomitant

Medications (CM)

Adverse Events (AE)

ECG (EG) Demographics (DM)

Exposure (EX) &

Exposure as

Collected (EC)

Medical History (MH)

Inclusion Exclusion Criteria (IE)

Device Exposure

(DX)

Healthcare Encounters (HO)

Subject Characteristics (SC)

Device Subject Relationship (DR) Clinical Events (CE) Death Details (DD)

Device Tracking (DT)

Vital Signs (VS)

Foundational Standards Implementations

39

Study Data Collection

Programming

(study datasets/reporting)

Statistics

(analysis datasets)

Clinical Study Reports

FDA

(submissions)

Publications Repositories

• Therapeutic Area User Guides (UG)

• Major Depressive Disorder

Device-hip (DR)

Look-up table providing single consistent link between

each device

and subject

Findings

Device Propert ies (DO)

Important unvarying device characteristic

s that are not identifiers

Device -In-Use (DU)

Measuremen

ts and settings intentionally set that may vary between uses of a device

Interve ntions

Device Expos ure (DX)

Subject’s exposure to

a medical device under study

Events

Device Events (DE)

Reportable device- related occurrences such as malfunctions and calibrations

Trackin

g and Disposi tion (DT)

Physical locations of device, either at each movement or just final

status

Devices Covered in Device IG

Device Not Under Study

Device Under Study

Class II & III

requiring submission

Single vs Multiple Component

Subject:Device 1:1

1:Many Many:1 Many:Many

Drug/Device Combos

CDISC Can Help…

• Core clinical data

• Therapeutic area data

• Device data including

• Pre-market UDI analogue

• Design to capture “in-use” settings

Defined data structures optimized for research and

designed for pooling

Also supports data repository structures to pool

repositories and pool with clinical research data

Understands HL-7 via ISO-approved BRIDG

Streamlines FDA submission production

Can interface and store clinical trials-related data

Informing patient care and safety through higher quality

medical research

Thank you!

• Implementation Guide for implementing CDASH

model for core and custom domains

• Codifies rules for capturing CDISC-conformant data

CDASH IG

• Study Data Tabulation Model

• Used to guide development of clinical and other study data structures

© CDISC 2016

CDISC Standards (2)

• Operational Data Model

• XML model for describing, transmitting & managing based data

CRF-ODM

• Laboratory

• Content standard for defining lab data

LAB

• Defines code lists/controlled terms for CDISC variables

• NCI’s Enterprise Vocabulary Enterprises provides controlled versioned management

Controlled

Terminology

• CDASH, SDTM & Controlled Terminology done together

• Initial focus: Implantable & similar devices

Devices

• Biomedical Research Integrated Domain Group Model

• Framework for clearly defining data elements and for linking and harmonizing to other standards

BRIDG

CDISC Standards (3)

• Shared Health and Research Electronic Library

• Central electronic repository for CDISC standards

• In development

SHARE

• Protocol Representation Model

• Structured way of describing protocol elements that allows them to be search on, e.g., eligibility criteria

PRM

• Standard for the Exchange of Non-clinical Data

• Pre-clinical data exchange definitions, currently animal toxicology and reproductive toxicology

© CDISC 2016

Standards-Related Resources

 Information about CDISC, the standards, education/training, membership, sponsorship, meetings/events, and more

• CDISC User Networks www.cdisc.org/cdisc-user-networks

• CDISC Discussion Forum www.cdisc.org/forum

http://www.cancer.gov/cancertopics/terminologyresources/CDISC

 Applies mostly to CDER & CBER

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm

 CDRH standards page

http://www.fda.gov/medicaldevices/deviceregulationandguidance/datastandardsmedicaldevices/default.htm

• MAGI: http://www.magiworld.org/standards/

• NIH: https://ncats.nih.gov/expertise/clinical

CDISC Education: Classroom

• Include major standards, e.g., CDASH, SDTM, ADaM

• Regularly scheduled public events in major cities globally

• Private training can be requested

at any time

Public

Licensed

Private

CDISC Education: Online

• Most major standards

• Therapeutic area standards

• 30-minute modules grouped into courses

• Videos, voice over slides, exercises

On Demand

Courses

• 60-90 minute members-only webinars

• Recorded and available on members site

• Deeper dive into focused topics

• Video, voice over slides, recorded Q&A

Mini-Training

Webinars

• 60-90 minute webinars later available online

• Focus on recently released draft and final standards

• Video, voice over slides, recorded Q&A

Public

Webinars

• Selected free modules available at http://cdisc.trainingcampus.netFree modules

CDISC Contact Information

and Helpful Links

membership@cdisc.org

training@cdisc.org

© CDISC 2016

For More on the World of Standards…

Please visit http://kestrelconsulting.trainingcampus.net , create an account, click Product Catalog, C-11 Free Courses from Kestrel, Kestrel-014a-Overview of Standards 2013

Webinar includes definitions of the acronyms in the slides, and explanations of the organizations’ functions

The World of Standards webinar was created by Kit Howard when she was a consultant at Kestrel It is not endorsed by CDISC Kit is not currently accepting consulting engagements