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