becomes widespread (the accessibility of data is discussed in more detail in the next chapter).c

The next frontier of the evolution of clinical research toward an electronic future is the electronic integration of clinical trials data and patients’ health records. This integration is anticipated to open new areas of research that feature enhanced risk assessment, improved natural history and epidemiological assessment, more reliable information, and better drug use.

The primary challenge is to develop standards to bridge the different standards and terminologies used in clinical trials with those used in medical recordkeeping. This process presents daunting difficulties, including:

  • Health records include a broader range of terminology than clinical trials. For example, a myocardial infarction might be described in a medical record as coronary insufficiency, chest discomfort, or other terms that may be difficult to capture in an electronic system.

  • The codes for most electronic health records were developed for reimbursement and billing purposes, not for clinical use or research.

  • Health records data are retrospective, which can make it difficult to check for errors.

Questions have been raised about whether digitizing individuals’ electronic health records will compromise their security and privacy. Will inappropriate usage be properly restricted? Will companies be able to acquire and share these data? If companies use the data to develop publications, will they later be liable to requests to make the primary data available to others? Another potentially difficult problem is that the merging of two datasets might make it possible to identify patients who have been “de-identified” in each.

Although these and other potential concerns must be addressed, the experience since implementation of 21 CFR Part 11 a decade ago is encouraging. Existing processes, standards, and computer systems have been largely effective in maintaining the accuracy, integrity, and privacy of data. Furthermore, there are grounds to believe that these experiences can be extended to the effective handling of individuals’ electronic health records—as witnessed, for example, by the success of the U.S. Department of Veterans' Affairs in developing secure practices.


a Frank W. Rockhold and Ronald I. Krall. 2006. “Trial summaries on results databases and journal publication” (letter). Lancet 367:1633–1635.


b Food and Drug Administration. 2003. Guidance for Industry, Part 11, Electronic Records; Electronic Signatures—Scope and Application. Available at


c Eve Slater, Director on the boards of Vertex Pharmaceuticals and Theravance, Inc., presentation to the committee, April 16, 2007.

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