Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine. "Appendix D: Discussion Paper: The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation." Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020: Workshop Summary. Washington, DC: The National Academies Press, 2012.
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Envisioning a Transformed Clinical Trials Enterprise in the United States
EHR is designed to enable preventive, clinical, and supportive services throughout an enrollee’s life. The development and maturation of EHR technologies promise to make practicable the application of genetic information to medical practice. The EHR is also designed to provide the continuous aggregate data that are essential for assessing the health of the enrolled population, continually improving the quality of care throughout the IHS, and supporting clinical research and professional education. Of paramount importance, however, is the fact that the EHR enables the system, the provider, and the researcher to follow up with the patient over time. Large population-based real-time evidence is the product of aggregated health system databases. Randomization is facilitated through super computer–based virtually-integrated information systems that merge administrative and clinical data from multiple sources. The virtually-integrated networks, spanning providers and payers, make it possible to enroll individuals in trials and to follow them going forward. The magnitude of the databases and the power of the tools make possible analyses that are responsive to the cultural diversity of the study populations.
The EHR is first initiated when the patient enrolls or enters any of the component organizations and services. Integrated with web-based mobile technology, the EHR “follows” the patient home, issuing reminders and monitoring compliance, as well as capturing incidents and wellness indicators (FasterCures, 2005). In 2020, there is wide public recognition that research is an integral component of community-based practice. The basic compact between the patient and the provider community is that every patient is a potential contributor to research. It is assumed that the patient record may be used for research in a de-identified data system. The patient-oriented part of the EHR is owned by the patient and is accessible only by the patient or by family members and providers to whom the patient grants access. Special permission is required to use such information in research projects that could potentially identify the individual.
The maintenance and improvement of professional competence is an objective of all IHSs and defines them, in the terms of an earlier IOM report, as “learning health systems” (IOM, 2011a). The formal relationships with providers across all participating settings as well as the aggregate clinical and administrative data generated by the EHR provide the foundation for feedback and for rigorous and sustained continuing education. Every health care delivery site is a learning site, providing continuing health education (CHE) that includes point-of-care reminders, links to clinical practice guidelines, and other online resources. This is in addition to traditional CME activities that are at once targeted to the objectives of the IHS and to the need for education where it is most effective—the point of patient engagement.