Volume 7 Issue 58 Journal for Clinical Studies

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Standards-based Technology for Integrating Electronic Health Records and Data Capture

Clinical researchers are strongly distancing themselves from paper with their increasing use of electronic health records (EHRs) and electronic data capture (EDC) systems. The US Food and Drug Administration (FDA) hopes to see even more progress with the direct use of EHRs to provide information for regulatory submissions.

To this end, the agency issued a Federal Register (FR) notice in June 2015 regarding data capture from EHRs using standardised clinical research data.1 The notice requested comments, proposed approaches, and interest in participating in demonstration projects to test the capability and evaluate the performance of using an end-to-end EHR-to-EDC single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centres, and other interested parties. Any project is expected to last approximately 12 months but may be extended as needed.

The FR notice explained that the information systems and the underlying data models that define both clinical care and clinical research are widely disparate. This was not an issue for the conduct of clinical research prior to use of EHRs or EDC because data were captured on paper case report forms (CRFs); however, the past decade has seen much change as EDC systems have become

ubiquitous in clinical trials for capturing data. Likewise, EHRs have had widespread acceptance and are swiftly becoming a standard part of clinical care.

In September 2013, the FDA published the final Guidance for Industry: Electronic Source Data in Clinical Investigations, which encourages use of electronic source (e-source) data in the conduct of clinical trials intended for inclusion in investigational and new drug applications. EDC from EHRs and healthcare devices (e.g., electrocardiogram management systems, digital imaging and mobile health devices, electronic patient-reported outcome [PRO] instruments) have the potential to improve the reliability, quality, integrity, and traceability of data from electronic source to regulatory submission.

The FDA recently elaborated on this topic in a webinar hosted by the Offices of Strategic Programs (OSP) and Translational Sciences (OTS) in the FDA’s Center for Drug Evaluation and Research (CDER).2 The OSP speaker, Ron Fitzmartin, PhD, MBA, explained that the agency’s intent with the 2013 final guidance was to encourage industry to conduct e-source trials. Since then, “very little” has been done in terms of conducting prospective, confirmatory trials using e-source technologies, Fitzmartin said. For this reason, the FDA intended with the FR notice and webinar to promote industry to conduct e-source data capture trials and to partner with industry to conduct

Journal for Clinical Studies 9www.jforcs.com

demonstration projects.

“We are very eager to see paper going away,” Fitzmartin said. “So what this webinar is about is hopefully the beginning of the end of paper. We want to see major changes, transformational changes, not just incremental changes.”

Fitzmartin tied in mention of the FDA’s December 2014 final Guidance for Industry: Providing Regulatory Submissions in Electronic Format—Standardized Study Data, and noted that the FDA would like the demonstration projects to use the study data standards that both CDER and the Center for Biologics Evaluation and Research (CBER) support for regulatory submissions. A listing of those standards is found in the FDA’s Data Standards Catalog.3

As for particular technologies, Fitzmartin noted that the FDA has been “technology agnostic” and thus did not specify technology types in the 2013 guidance or the FR notice. Still, the agency would like sponsors to leverage new technologies to implement the e-source guidance. Pharmaceutical companies are “always risk-averse,” he said, and do not want to deploy new technologies for fear of them being questioned by the FDA. The agency believes that technologies currently exist and also are emerging and that they need to be deployed, Fitzmartin said.

The second speaker, Mitra Rocca with the OTS, highlighted the flow of information in an end-to-end EHR-to-EDC single-point data capture approach. EHR data are first collected and stored in an EDC system. The data are then housed by the sponsor or contract research organisation (CRO) in a clinical trial management system (CTMS). Lastly, the data are transmitted to the FDA’s Electronic Submissions Gateway (ESG), from where they are accessed by FDA reviewers.

During the webinar’s question and answer period, the FDA was asked whether it is truly essential to have an EDC system between the EHRs and the CTMS. Rocca replied that, ideally, the data could travel directly from EHRs to the CTMS. In reality, however, EDC already exists between those two ends. Fitzmartin added that, from the FDA view, it is possible to have the data move directly into a central repository instead of entering an intervening data management system; the uncertainty is whether the technology exists to do that (e.g., embedding some type of EDC system into an EHR system, and having the data enter a clinical database).

A related question was why the system storing data for EHRs would not, by default, be an EDC system. Fitzmartin explained that clinical research systems (e.g., EDC) are regulated under 21 Code of Federal Regulations (CFR) part 11, whereas health information technology (IT) systems (e.g., EHR) are regulated under 45 CFR part 170. Given this, the FDA stated in the 2013 guidance that it

“does not intend to assess the compliance of EHRs with part 11.”

Requested Demonstration Projects and Stakeholder InputDemonstration projects are expected to assess and report value and challenges of the EHR-to-EDC single-point capture of source data in a clinical research environment. According to the FDA, streamlining clinical research at the source may open up opportunities to improve clinical trial design and execution, speed the cycle of clinical research, and get medicines to market faster. Specifically, a standards-based technology solution in clinical trials has the potential to:

• Eliminate duplication of data by capturing and transmitting e-source data;

• Auto-populate the electronic study forms from EHRs;• Reduce transcription errors and improve data quality;• Encourage entering source data at the point of care;• Facilitate remote monitoring of data to reduce

the number of on-site visits by regulated biopharmaceutical industry;

• Improve site monitoring to minimise the need for cross-reference data in multiple sources;

• Make it easier for investigators to conduct clinical research;

• Facilitate the FDA’s inspection and reconstruction of clinical investigations; and

• Improve the standards-based technology solution to encourage widespread adoption.

The FR notice listed six questions on the topic of standards-based technology solutions for EHR-EDC integration and welcomed stakeholder feedback to the public docket. For participation in the demonstration project, interested stakeholders were to submit their requests to the docket by August 10, 2015.

References1. Federal Register: Vol. 80, No. 123 (June 26, 2015)2. CDER SBIA Webinar - Federal Register (FR) Notice:

Source Data Capture from Electronic Health Records: Using Standardized Clinical Research Data - July 7, 2015

3. Data Standards Catalog. Available at: http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm

Deborah A. Komlos, MS, is the Senior Medical & Regulatory Writer for the Cortellis Regulatory Intelligence US Module at Thomson Reuters. Her previous roles have included writing and editing for magazines, newspapers, online venues, and scientific journals, as well as publication layout and

graphic design work. Email: deborah.komlos@thomsonreuters.com

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