eSource on FHIR - DCHI...Apr 03, 2018 · eSource on FHIR Food and Drug Administration CDER Health...
Transcript of 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