First electronic medical record to support clinical research

1985

Challenge

As clinical trials become more complex, with patients often seeing multiple study professionals including specialists, pharmacists, nurses, and others, it has grown increasingly difficult to accurately track patient information and study results over time. A way to accurately record patient information in an accessible and secure database was needed.

Advance

NIH Clinical Center staff led by Thomas Lewis, M.D., adapted a first-in-class, hospital-wide electronic medical record (EMR), which allowed for the collection of data in an outpatient clinical trial. The EMR allowed researchers to structure data (fixed- and variable-length) that was automatically encoded after being entered directly by physicians and nurses at the time of patient contact, using procedures already familiar to them through routine patient care. 

Impact

This novel hospital-based EMR was the first to be adapted in support of a clinical trial. By using an electronic data collection system, protocol data was improved in accuracy, completeness, and timeliness, at very low marginal costs.

Publications

Foy JL, Palestine AG, Nealon RC, Vincent WD, Nussenblatt RB, Lewis TL. (1985). Adapting a Hospital Information System to Data Collection for Clinical Research. Proc Annu Symp Comput Appl Med Care. 846–851.