esource on fhir - dchi...apr 03, 2018  · esource on fhir food and drug administration cder health...

eSource on FHIR

Food and Drug Administration CDER Health IT Board March 27, 2018

Amy Nordo MMCi, BSN, CPHQEd Hammond PhD

Background: Moving away from the “swivel chair” method in clinical research.

Manual abstraction of EHR data for use in clinical

research

Costly Error-Prone SlowChair image source: http://www.zueco.com/en/produkte/conference/signo; icon source: various artists at flaticon.com

Slide credit to Ben Parker MD/ MBA Candidate Duke University

Background: Traditional workflow labor-intensive, relies on two data-related FTEs.

Source: Nordo AH 2017

Slide credit to Ben Parker MD/ MBA Candidate Duke University

Background: eSource-based data transfer simplifies workflow, reduces error potential.

Source: Nordo AH 2017

Slide credit to Ben Parker MD/ MBA Candidate Duke University

37% Time Reduction

30% Scrolling Reduction

65% Keystroke Reduction

1 Fewer FTE Needed

Proof of concept: Implementation of informatics has a profound impact.

1.7%Fraction of data

captured electronically

100% Data Quality Rate

Source: Nordo AH 2017; icon source: various artists at flaticon.com

Slide credit to Ben Parker MD/ MBA Candidate Duke University

Importance / potential: Biopharma industry is enthusiastic and invested in moving forward.

“The eSource Initiative supports

TransCelerateMember

Companies in accelerating the

uptake of eSource for clinical trials…”

Source: http://www.transceleratebiopharmainc.com/initiatives/esource/

Slide credit to Ben Parker MD/ MBA Candidate Duke University

Importance / potential: Food and Drug Administration is enthusiastic and invested in

moving forward.

Importance / potential: Fast Healthcare Interoperabilty Standard (FHIR) provides

necessary technical interoperability

Image source: https://www.google.com/search?biw=1536&bih=720&tbm=isch&sa=1&ei=uO2nWqznBoHq_Ab2xargAg&q=fhir+interoperability&oq=FHIR+inter&gs_l=psy-ab.1.0.0i24k1l4.2505.4431.0.6089.12.11.1.0.0.0.88.651.11.11.0....0...1c.1.64.psy-

ab..0.11.595...0j0i67k1.0.zFL6Nfe5MZc#imgrc=94Mj80aOXzzMwM:

Duke’s Solution

Hold this slide for video

Image source: https://www.google.com/search?q=next+steps&tbm=isch&tbo=u&source=univ&sa=X&ved=0ahUKEwj_wvyYyunZAhUkm-AKHXmDDScQsAQIKA&biw=1536&bih=759#imgrc=LCsdt-GV55U2nM:

Cross Collaboration: Key solution relies on understanding of multiple stakeholders

perspectives.

Develop a Single solution based on Standards; (leveraging existing standards) that meets the requirements of all stakeholders.

Economic value of eSource in Clinical Trial Data Capture Practicum: Key question relies on

understanding of multiple sub-elements.Given infrastructure expense and adoption challenges…

Under what specific circumstances does investment in eSource “make sense?”

Implementation logistics

Partner trial sites & CROs

Economics Clinical trial characteristics

Icon source: various artists at flaticon.com

Slide credit to Ben Parker MD/ MBA Candidate Duke University