201709 Clinical Research

Track Name

Clinical Research Track

Submitting WG/Project/Implementer Group

Biopharma FHIR project group; TransCelerate Biopharma eSource Work Stream

Justification

This track is intended to continue to further explore the benefits of FHIR for clinical research of new biopharmaceutical experimental treatments, and to increase visibility of FHIR within the biopharmaceutical community. This track advances the use of FHIR resources as eSource data used to pre-populate clinical research case report forms for both regulated and non-regulated clinical research. This builds on previous explorations in Connectathon 13 and 14.

Clinical Research studies currently require the redundant entry of clinical data that already typically resides in Meaningful Use conformant EHR systems. EHR data represents original records in electronic format that can be used as eSource and directly imported into clinical research EDC databases so as to improve the quality and consistency of data between EHR and EDC systems and eliminate the need for redundant data entry. Establishing interoperability between EHR and EDC systems to streamline and modernize clinical investigations should improve data accuracy, patient safety, and clinical research efficiency. Given the extreme cost and extended time required for randomized clinical trials, it would be substantially better to utilize EHR source data to directly populate clinical trial databases wherever feasible. The May 2016 FDA draft guidance titled “Use of Electronic Health Record Data in Clinical Investigations” encourages the sponsors of clinical research to use EHR data as noted in the statement below. FDA encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as health care organizations, to use EHRs and EDC systems that are interoperable. EHRs may be interoperable with EDC systems in a variety of ways depending on supportive technologies and standards. Interoperable technology may involve automated electronic transmission of relevant EHR data to the EDC system. For example, data elements originating in an EHR (e.g., demographics, vital signs, past medical history, past surgical history, social history, medications, adverse reactions) may automatically populate the eCRFs within an EDC system.

TransCelerate Biopharma, a consortium of 18 of the largest global pharmaceuticals, has engaged an eSource project team that will be sending representatives to the Madrid Connectathon seeking to further assess the readiness of FHIR toward the goal of creating a FHIR IG for Clinical Research. This project will build on prior work and also explore in more detail the processing of local lab data collected for patients experiencing Serious Adverse Events, which is currently a challenging prospect for clinical trials.

Proposed Track Lead

See Connectathon_Track_Lead_Responsibilities Wayne Kubick (wkubick@hl7.org), Sam Hume (swhume@gmail.com); Geoff Low (glow@mdsol.com); Trisha Simpson (trisha.simpson@ucb.com)

Expected participants

TransCelerate Biopharma, Inc., UCB, Pfizer, Novo-Nordisk, GSK, Merck, Lilly, Medidata, Oracle Health Sciences

Roles

Please include information here regarding how much advance preparation will be required if creating a client and/or server.

Scenarios

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