Photo: eSource Challenge Judges Munther Baara (second from left, Pfizer) and Chuck Jaffey (third from left, CEO of HL7), with winner Michelle Crouthamel (third from right, GSK)

Overview:

As healthcare records have been increasingly digitized, sources of electronic health data need to be structured and standardized. HL7 (Health Level Seven International), a not-for-profit, ANSI-accredited standards developing organization has developed the FHIR (Fast Health Interoperability Resources) Specification, which serves as a standard for the electronic exchange of healthcare information. HL7’s FHIR Connectathon gives participants the chance to work with the FHIR specification outside a production environment. This feedback improves FHIR and ultimately advances the industry.

A Connectathon is an event where innovative, boundary-breaking expertise from business, academia, and technology come together to solve critical challenges and test solutions in a safe environment. The HL7 FHIR Connectathon took place in San Diego, CA from September 9-10. It aimed to progress the clinical trial research community towards utilizing complete and interoperable electronic health records (EHRs) in clinical trials.

TransCelerate Member Companies submitted 12 use cases, which were then narrowed down to three use cases that were solutioned during the event:

Use Case 1

Identify qualified patients for trials

Examining EHR patient data for protocol feasibility and clinical trial recruitment for a specific clinical trial

Use Case 2

Automatically populate eMR information in EDC

Extract relevant EHR data for Research Subject and import into Study Database

Use Case 3

Apply real world evidence updates to study databases

Receive and apply Real World Evidence updates to the study database as new or changed data is recorded in the EHR or received from patients

Congratulations to Michelle Crouthamel (GSK) for winning the TransCelerate eSource Challenge!

TransCelerate hosted an eSource Challenge to the Member Company team whose accepted HL7 FHIR Connectathon use case most advances eSource across the industry. Judging for the Connectathon eSource Challenge proved to be very challenging as each of the talented teams involved did an excellent job of both coding and collaborating. Use Case 2, led by Michelle Crouthamel (GSK), edged out a narrow victory as it prompted several technical solutions, including the “ability to go direct to SDTM after transferring EHR data to an EDC, which ultimately would provide more efficiencies in getting data delivered faster.” (Munther Baara, Pfizer, Connectathon Judge)

 

Collaboration at the FHIR Connectathon, featuring TransCelerate eSource Challenge uses cases.

The Clinical Research Track had over 20 participants, tripling participation in this track from previous HL7 Connectathons. This group featured representatives from five Member Companies, as well as five vendors. Thanks to the members of the eSource team who worked to make this event a success:

  • Munther Baara, Pfizer
  • Michele Cherry, Pfizer
  • Michelle Crouthamel, GSK*
  • Donald Jennings, Lilly*
  • Ed Keller, Astellas
  • Linda King, Lilly
  • Jesper Kjær, Novo
  • Heather Langan, Allergan
  • Prasann Mehta, Merck*
  • Joanne Pojuner, Merck*
  • Trisha Simpson, UCB
  • Jean Sposaro, TransCelerate
  • Ashley Tiseo, Accenture
  • Brett Wilson, Pfizer
  • *use case submitter

In addition to the Connectathon, TransCelerate and HL7 co-hosted an eSource Realization Roundtable, where 32 industry leaders met to discuss possibilities to facilitate eSource adoption, the use of electronic health records, and data interoperability in clinical research. This group included representatives from Academic Sites, Health Authorities (FDA, EMA), CDISC, HL7, Technologists, six TransCelerate Member Companies, and four TransCelerate Initiatives and Councils (eSource, Patient Technology, Regulatory Council, Technology Council).

The eSource team is currently working on use cases for the next Connectathon, which will take place in New Orleans on January 27-28, 2018. View details for the event here.