CDISC, HHS/ONC and FDA Issue Challenge: Regulated Clinical Research Study using EHRs

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CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated clinical research during a Session on 26 June at the Annual DIA meeting in Philadelphia. Specifically, clinical research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated clinical research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct clinical research studies.

CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated clinical research during a Session on 26 June at the Annual DIA meeting in Philadelphia. Specifically, clinical research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated clinical research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct clinical research studies.

This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated clinical research and increase its capacity throughout the US and the world as EHR adoption is being encouraged and increasing rapidly. Wayne Kubick, Chief Technology Officer (CDISC), spoke first at the DIA session: “CDISC has been doing demonstrations of its Healthcare Link methodology for years now, at HIMSS and at DIA. By adopting the CDISC-IHE profiles used in the CDISC Healthcare Link solution, EHRs can readily implement the standards and profiles to enable the collection of a high quality clinical research dataset that is needed for any regulated clinical research study.”

Jonathan Helfgott (CDER/FDA/HHS) stated that it is of interest to the regulated stakeholders to leverage EHRs. He showed the actual processes and standards that can be used now to ensure patient confidentiality, security and conformance to the regulations for EHR-based clinical research to support electronic submissions to FDA. He also mentioned the value to FDA of being able to remotely access electronic source data to enable audits. These standards, processes and electronic source data (eSource) archive are key features of the CDISC Healthcare Link Initiative, led by Landen Bain.

Jane Griffin (Cerner), provided a case study of clinical research being conducted at Florida Hospital using their EHR. She stated: “In the development of our existing clinical research processes, we were ‘missing the site’ as a stakeholder. By leveraging the EHR, we are making it easier for the site and also facilitating monitoring from afar.”

Dr. Doug Fridsma (HHS/ONC) spoke of the U.S. Meaningful Use initiative to increase the use of EHRs; adoption has increased from 20 to 40% in the past 2 years. He said that Stage 1 was ‘making things electronic’, Stage 2 was ‘getting the data to move’ and Stage 3 will be ‘doing interesting things with the data (or learning from the data)’. “We will have 18 months to try to understand the EHR data and how to better learn from it. Clinical Research is fundamental and we should be leveraging EHRs for this purpose,” stated Dr. Fridsma. “We look forward to seeing who will step up to this challenge.”

Since most investigators conduct one clinical research study and no more due to the cumbersome existing processes, it is time to change this scenario such that clinical research is not difficult for clinicians and we can learn more from clinical care. Further information about the CDISC Healthcare Link can be obtained through this website: http://www.cdisc.org/healthcare-link. Anyone interested in taking this challenge should provide information through this form (http://cdisc.wufoo.com/forms/m7p7q7/).

ABOUT CDISC
CDISC is a 501(c)(3) global non-profit charitable organization, with ~300 supporting member organizations from across the clinical research and healthcare arenas. Through the efforts of volunteers around the globe, CDISC catalyzes productive collaboration to develop industry-wide data standards enabling the harmonization of clinical data and streamlining research processes from protocol through analysis and reporting, including the use of electronic health records to facilitate the collection of high quality clinical research data. The CDISC standards and innovations can decrease the time and cost of medical research and improve quality, thus contributing to the faster development of safer and more effective medical products and a learning healthcare system. The CDISC Vision is to inform patient care and safety through higher quality medical research.

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Diana Harakeh
CDISC
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