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Current Status of Integrating Information Technologies into the Clinical Research Enterprise within US Academic Health Centers
  1. Fran Turisco,
  2. Diane Keogh,
  3. Connie Stubbs,
  4. John Glaser,
  5. William F. Crowley Jr
  1. From Emerging Practices First Consulting Group (F.T.), Boston, MA; Corporate Information Technology Services Department, Partners Healthcare Inc. (D.K., J.G.), Boston, MA; Clinical Research Program, Department of Medicine (C.S., W.F.C.), Massachusetts General Hospital, Boston, MA.
  1. Address correspondence to: Dr. William F. Crowley Jr, Massachusetts General Hospital, Director of Clinical Research, Bartlett Hall Extension Building, Room 511, 55 Fruit St., Boston, MA 02114.

Strategic Value and Opportunities for Investment

Abstract

Little information exists about the incorporation of information technologies (ITs) into clinical research processes within US academic health centers (AHCs). Therefore, we queried a group of 37 leading AHCs regarding their current status and future plans in clinical research IT. The survey specifically inquired about the presence or absence of basic infrastructure and IT support requirements; individual applications needed to support study preparation, study conduct, and its administrative support; and integration of data from basic research, clinical trials, and the clinical information systems increasingly used in health care delivery. Of the 37 AHCs, 78% responded. All strongly agreed that a “state-of-the-art” clinical research IT program would be ideal today and will be essential tomorrow. Nonetheless, no AHC currently has an IT solution that even approached this ideal. No AHC reported having all of the essential management foundations (ie, a coherent vision, an overall strategy, a governance structure, and a dedicated budget) necessary to launch and sustain a truly successful implementation of a cohesive clinical research IT platform. Many had achieved breakthroughs in individual aspects of clinical research IT, for example, adverse event reporting systems or consent form templates. However, overall implementation of IT to support clinical research is uneven and insufficient.

These data document a substantial gap in clinical research IT investments in leading US AHCs. Linking the clinical research IT enterprise with its clinical operations in a meaningful fashion remains a crucial strategic goal of AHCs. If they are to continue to serve as the “translational research engines” that our society expects, AHCs must recognize this gap and allocate substantial resource deployment to remedying this situation.

Key Words
  • clinical research
  • information technology
  • human research
  • academic health centers
  • medical research
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