Clinical research is the foundation for advancing the practice of medicine. However, the lack of seamless integration between clinical research and patient care workflow impedes recruitment efficiency, escalates research costs, and hence threatens the entire clinical research enterprise. Increased use of electronic health records (EHRs) holds promise for facilitating this integration but must surmount regulatory obstacles. Among the unintended consequences of current research oversight are barriers to accessing patient information for prescreening and recruitment, coordinating scheduling of clinical and research visits, and reconciling information about clinical and research drugs. We conclude that the EHR alone cannot overcome barriers in conducting clinical trials and comparative effectiveness research. Patient privacy and human subject protection policies should be clarified at the local level to exploit optimally the full potential of EHRs, while continuing to ensure participant safety. Increased alignment of policies that regulate the clinical and research use of EHRs could help fulfill the vision of more efficiently obtaining clinical research evidence to improve human health.
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http://dx.doi.org/10.1136/amiajnl-2012-000878 | DOI Listing |
Ann Intern Med
January 2025
Medical University of South Carolina, Charleston, South Carolina, USA (S.P.H.).
GIM/FP/GP: [Formula: see text] Geriatrics: [Formula: see text].
View Article and Find Full Text PDFJ Med Internet Res
January 2025
Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.
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J Med Internet Res
January 2025
Working Group for Data-Driven Innovation, Hamburg University of Technology, Hamburg, Germany.
Background: Health care innovation faces significant challenges, including system inertia and diverse stakeholders, making regulated market access pathways essential for facilitating the adoption of new technologies. The German Digital Healthcare Act, introduced in 2019, offers a model by enabling digital health applications (DiGAs) to be reimbursed by statutory health insurance, improving market access and patient empowerment. However, the factors influencing the success of these pathways in driving innovation remain unclear.
View Article and Find Full Text PDFJ Med Internet Res
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Nursing Pharmacology and Physiotherapy Department University of Córdoba, Lifestyles Innovation and Health (GA-16) Maimonides Biomedical Research Institute of Córdoba (IMIBIC) Spain, University of Córdoba, Córdoba, Spain.
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View Article and Find Full Text PDFJ Med Internet Res
January 2025
Center for Health Services Research, Faculty of Health Sciences Brandenburg, Brandenburg Medical School Theodor Fontane, Rüdersdorf bei Berlin, Germany.
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