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International Clinical Trials

The Time is Now

The development of a patient-oriented healthcare environment that can enhance patient safety and reduce healthcare costs is urgently needed (1). In order to help meet this need, a transition from paper-based patient health records and source documents to their electronic equivalent has been occurring, as evidenced by the utilisation and global adoption of the electronic health record (EHR).

Though a dedicated electronic data capture (EDC) system that is able to capture essential clinical research data can be considered a very good asset, the associated process can be improved for an investigative site through integration of the EDC capabilities with an EHR.

A pragmatic solution involves a more comprehensive system, such as an extended EHR, that can efficiently update data capture and support a framework that allows for the exchange of healthcare and clinical research data, while meeting the existing regulations, allowing for more efficient clinical care and clinical research processes (1).

Currently, moving the case report form (CRF) to the EHR is being resolved and a viable solution has been demonstrated. Therefore, clinical research conducted via extended EHRs can provide several advantages to healthcare providers, clinical researchers, and their patients. These advantages will enhance best practices and include:

  •  A reduced burden placed on healthcare professionals conducting clinical research
  •  An increase in the quality of data captured during clinical research processes
  •  Improved patient care
  •  Improved product and patient safety

THE VALUE CASE FOR CONDUCTING CLINICAL RESEARCH USING EHRs

Clinical research-enabled EHRs reduce the time requirements placed on healthcare providers and data coordinators due to the reduction in

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Jacob Helton is a technical writer for Clinical Data Interchange Standards Consortium. In addition, he is a mobile therapist/behavioural specialist consultant working with special needs children and adolescents. As a mental health professional, he provides psychological services to children, adolescents, and their families. Jacob received a BS in Psychology from Greensboro College and holds a MA in Child Clinical Psychology from Marywood University.

Landen Bain works with CDISC as liaison to the healthcare information community to develop and implement data exchange standards between healthcare and medical research. He focuses his efforts on realising improved interoperability today, with the immediate demonstration and implementation of existing standards. Landen served for over 20 years as Chief Information Officer of Duke University Health System in Durham, North Carolina and Ohio State University Hospitals in Columbus, Ohio. He was recognised by the HL7 Board as an ‘HL7 Pioneer’ in 1991 for his work as an early adopter of HL7 while at Ohio State University. He is a charter member of the College of Healthcare Information Executives.

Rebecca Daniels Kush is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC) a non-profit organisation with a mission to develop and support global, platformindependent data standards that enable information system interoperability to improve medical research and related areas of healthcare. Rebecca has been in the field of clinical research for over 25 years. She has worked for the NIH, academia, a global CRO and pharmaceutical companies in the US and Japan. She holds a BS in Chemistry and Biology from the University of New Mexico and earned her PhD in Physiology and Pharmacology from the University of California (UCSD) School of Medicine.

Linda King joined Eli Lilly and Company in 1998 where she previously lead multiple data management teams, supporting a multi-indication compounds with Phase IIb- IV clinical trials and multiple submissions. Currently, she is the leader of a technology and process lead team within the data sciences and solutions function. She graduated from the University of Michigan with a Bachelor of Science degree in Biology with Honours. Linda is an ASCP board certified medical technologist and has held board certifications as a histocompatibility technologist and a histocompatibility specialist. Email: king_linda_s@lilly.com

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Jacob Helton
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Landen Bain
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Rebecca Daniels Kush
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Linda King
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