The eSOURCE STAKEHOLDERS GROUP

Michael A. Ibara, Pharm.D.

Head of Digital Healthcare

CDISC

@michaelibara

A note on the distribution version of these slides: These slides are designed specifically to support the talk I gave, and not as a standalone document. They provide visual support during my talk, and I make many points verbally that are not spelled out in the slides. I apologize, then, if some points seem opaque because of this, and if you want to know more I’m happy to have a quick chat or email exchange to explain anything.

Having said this, I hope you can glean some information from them about the rationale and direction for the eSource Stakeholders Group. We welcome inquiries or volunteers!

You can reach me at mibara@cdisc.org, or at michael.ibara@gmail.com

Thank you!

The ideas and opinions in this talk are mine and not necessarily those of CDISC, or indeed any other human being

26Jun2015 FDA Federal Register Notice

https://www.federalregister.gov/articles/2015/06/26/2015-15644/source-data-capture-from-electronic-health-records-using-standardized-clinical-research-data

“The Center for Drug Evaluation and Research (CDER) is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties.”

NotBeaten

“Any one of your will set out virtually anywhere in the world with a [credit card] in your pocket with complete confidence that you will be transported, housed, fed, clothed, and entertained, with all the complex information that requires – currency conversions, language translations, and financial settlements – handled within seconds with complete privacy and 99.99 percent accuracy...”

One From Many: VISA and the Rise of the Chaordic OrganizationDee HockPrinceton University PressBerrett-Koehler Publishers, Inc. 2005

“How can it be that you cannot provide anything remotely comparable if I walk down the hall or across the street between medical practitioners, hospitals, or laboratories...?”

One From Many: VISA and the Rise of the Chaordic OrganizationDee HockPrinceton University PressBerrett-Koehler Publishers, Inc. 2005

Year: 2005

2016- 2005

11

Year 2005:- President is George W. Bush - Katrina hits New Orleans- 4 Terrorist attacks in London- Pope John Paul II dies- Angela Merkel elected- YouTube launched- iPhone does not exist

2016- 2005

11

“How can it be that you cannot provide anything remotely comparable if I walk down the hall or across the street between medical practitioners, hospitals, or laboratories...?”

Our usual explanation for why the lack of progress...

Theory of Relativity...

...of who is responsible!

What is observed depends upon who is doing the observing

“If only X would do Y we’d have progress” Where: X = Anyone but me; and Y = Anything that is not my responsibility

The explanation for lack of progress is explained by the statement...

An alternate explanation...

“...participants must share a body of knowledge and techniques. It’s that body of knowledge and techniques that they use to collaborate.”

Reinventing Discovery Michael Nielsen Princeton University Press2012

“When this shared body exists, we’ll call it a shared praxis, after the word praxis, meaning the practical application of knowledge.”

Reinventing Discovery Michael Nielsen Princeton University Press2012

(a body of knowledge and techniques)

“And if a group doesn’t have such a shared praxis, then disagreements will arise that can’t be resolved. Once an unresolvable disagreement arises, the community will begin to fragment...”

Reinventing Discovery Michael Nielsen Princeton University Press2012

The eSource Stakeholders Group arose from the sobering realization that the full list of stakeholders involved in making eSource a success had never been in the same conversation, let alone ever developed a shared praxis...

A lack of shared praxis is a major reason, despite excellent efforts amongst various stakeholders, we’ve not seen real progress against the problem of eSource as a whole

RegulatorsBiopharma industryMedical device industryCROs (contract research organizations)Academic medical centersClinical provider study sites Hospitals EHR vendorsEDC vendorsTechnology service providers SDOs (standards development organizations)Patients / Patient groups

eSource Stakeholders – a partial list:

Individual stakeholder groups (e.g., regulators, pharma, academic medical centers, etc.) have shared praxis, but taken as a whole, there is none

“Any...attempt at collaboration inevitably gets bogged down in discussions about basic values, ... agreement doesn’t scale...”

Reinventing Discovery Michael Nielsen Princeton University Press2012

How do you encourage collaborative problem-solving when there is a lack of shared praxis?

1) Focus on communication, collaboration

2) Build a conceptual foundation3) Stand up a model that can be

examined and improved over time

eSource StakeholdersGroup

3 Months in...

• 18 March 2016 First Meeting

• Great interest

• Challenge to understand full range of stakeholders

• Groups now working through topics

Stakeholders in the room...

• Academic med centers • Biotech • Consulting• CROs• EHRs / EDCs • Medical devices • Biopharmaceutical • Technology service providers • PMDA, Nat'l Eye Inst, FDA• …

5 Topics + Primer

Provenance (Data, process)

eCRF concept

System Validation / Privacy

Economics / Cost vs Benefit

Scalability requirements (technical, regulatory, political)

eSource Stakeholder Group Leads

Primer ..........................................

Data Provenance ........................

eCRF concept ..............................

System Validation / Privacy .......

Economics / Cost vs Benefit ......

Scalability requirements ..............

Angela Gill-Nelms; Dave Gemzik

Robert Barr; Liz Murphy

Mitra Rocca; Michael Ibara

Jennifer Price

Lee Walke; Keith Marsolo

Bart Phillips; Rob Poorvin

eSource Conceptual Foundations

The goal...

Data is captured in the EHR or some other electronic source

<d> is a datum or data

<d> is somehow moved to the researcher, where it may be transformed in some manner, to become d-prime <d’>

It is then submitted to the regulator, where it has become d-double-prime

data repository

The Regulator’s Dilemma...

• Can I go from <d’’> back to <d>?

• What information do I need to determine <d> in the original context?

• Can I look at the EHR as it appeared on the day that <d> was extracted?

• How do I know that the <d’’> that I see is equivalent to <d>?

The firewall...

The site or ‘owner’ of the data will not allow raw data to pass outside or others to pass inside the firewall...

The Researcher’s Dilemma...

• How do I get <d> without violating patient privacy, privacy laws, etc.?

• Do I execute a business agreement, then can I reach in? • Do I wait for something to be pushed to me? • How will this affect audit trail, provenance?

The eCRF...

A possible solution to the firewall challenge is to use an eCRF

eCRF Concept

• What is the eCRF? Which data fields? The C-CCD? • What happens to the data in the form that is not needed for the study

data? • What happens to the form itself, is it destroyed, archived, routed to

someone? • Do APIs obviate the need for an eCRF or just change the content? • Who ‘owns’ the process and where does ownership change - what are the

lines of demarcation?

Validation...

Sponsors are required to satisfy 21CRFPart11

There are other GCP, validation, etc. requirements for the systems and processes involved

Data Provenance

“Data provenance refers to the ability to trace and verify the creation of data, how it has been used or moved among different databases, as well as altered throughout its lifecycle.” [http://itlaw.wikia.com/wiki/Data_provenance]

• “What”, “When”, “Why”, “Who”, etc. vs other definitions

• Metadata necessary?

• Human vs computer readable?

Provenance work in EU FP7 TRANSFoRm Using data provenance to embed reproducibility in the Learning Health System

Dr Vasa CurcinBiomedical Informatics Group

Division of Health and Social Care / Dept of InformaticsKing’s College London

Economics / Cost vs Benefit

• What are the benefits to the site(s) and how and at what level are the measured?

• What are the benefits to the researcher / sponsor?

• What are the costs to realize these benefits?

• How do these apply in a heterogeneous environment?

Scalability Requirements (tech, reg, political)

• How do the economics scale?

• How does a solution scale in a technologically heterogeneous environment?

• What are the gaps (tech, reg, political, other) that need to be addressed to achieve scalability?

eSource Stakeholders Group: Next Steps

1) Focus on communication, collaboration

2) Build a conceptual foundation

3) Stand up a model that can be examined and improved over time

eSource Stakeholders Group: Next Steps

CDISC seeking to work directly with sponsors on demonstration projects

One effort getting underway, seeking a second

Providing support and working as liaison to shepherd the project along the path

Copyright ©2015 TransCelerate BioPharma Inc., All rights reserved. 50

eSource Initiative

Vision: Moving the industry to optimize the use of electronic data sources to improve global clinical science and global clinical trial execution for patients, sites and sponsors.

Landscape Assessment - Targeted Publication: November 2016 & March 2017- Current State & Gaps - Considerations to Advance eSource Adoption- Value Proposition - Technology and Research Site Environment

Point of View/Position Paper - Targeted Publication: Mid-2017- Data Privacy and Security - Regulatory Concerns- General Principles - Data Validation- Technology Landscape - Data Analytics & IT Challenges

Initiative Assets - Practical Tools to Facilitate Utilization of Electronic Source Data

Metrics/KPIs Change Management Stakeholder Engagement

Demonstration Projects – Examples of Study-Level Implementation

- We will provide a framework to help solve the challenges.- We will NOT develop standards or eSource technologies.

Electronic Health Records Direct Data CaptureNon-CRF Data Devices and Apps

Working Groups

eSource Stakeholders Group: Next Steps

European Meeting

18 October 2016

London

Agenda TBD

eSource Stakeholders Group: Next Steps

Publish

Blogs

White paper

Research

We welcome all interested parties from any discipline who seek to build a model of collaboration across eSource Stakeholders

"...the attention of the right expert at the right time is often the single most valuable resource one can have in creative problem solving. Expert attention is to creative problem solving what water is to life in the desert: it’s the fundamental scarce resource."

Reinventing Discovery Michael Nielsen Princeton University Press

We need your expertise and your interest!

Thank You