A Radical Proposal: Integrate Clinical Investigation into the U.S. Health Care System

Abstract

Integration of the clinical research enterprise into the U.S. health care system would ultimately improve public health.

Leveraging real-world data to investigate multiple sclerosis disease behavior, prognosis, and treatment

“…Currently, patient care and clinical investigation are largely separate activities in most institutions. 89 Data acquired during patient care are sometimes entered into registries and utilized for research, but the process often is inefficient, and the data may not directly inform the care of individual patients from whom the data are generated. The widespread implementation of EMRs offers the opportunity for more efficient collection of standardized comprehensive data during patient encounters for use in both patient management and clinical research.…”

Data collection as a barrier to personalized medicine

“…The complexity of many clinical issues leaves no alternative but to base clinical research on data collected from large populations of patients treated in everyday practice. Thus, the challenge for the clinical research enterprise is the development of methods for collecting standardized clinical data in routine practice [14] and not to rely on data collected by different physicians using variable funds of knowledge, cognitive skills, available time, and unverifiable heuristics.…”

The Future of Research in Multiple Sclerosis

“…In fact, patient care and research are separated at many levels, making systematic learning difficult within the health care system. 6 The need for transformation in health care to facilitate systematic learning has been emphasized by the President's Council of Advisors on Science and Technology and by the Institute of Medicine. 7,8 Standardized approaches to outcomes assessment, application of new technologies, adoption of informatics solutions, and reimbursement for outcomes as opposed to services, procedures, and products are expected to drive this transformation.…”