Configuration Challenges: Implementing Translational Research Policies in Electronic Medical Records
This is a review of Kahn's 2007 article, Configuration Challenges: Implementing Translational Research Policies in Electronic Medical Records. 
In order to create medical innovation whether it be via devices, diagnostic tools, or treatments, studies using robust scientific methods need to be conducted. However, recruiting human subjects is very difficult. Only about 7 % of eligible patients enroll in clinical trials. The vast majority of clinical trials fail to complete on schedule, usually due to investigators failing to recruit enough subjects.
One of the challenges to using an EMR for both clinical care and clinical research is defining what kind of record access is appropriate when many of the players will be playing different roles. The authors state, “the same individual user could assume multiple roles, even for a single patient during a single encounter.” For example, the principal investigator for a study may be a study participant’s attending physician.
The authors provide a table demonstrating examples of how electronic medical record (EMR) systems could not only support clinical care but also clinical research. This includes study specific issues such as setup, enrollment, and execution; submission and reporting; evidence based review; and evidence-based clinical care.
It is important to create an integrative EMR that considers clinical care and clinical research, multiple user roles, and system workflow without impeding productivity. The authors provide a second table raising questions about role vs. access. For example, if the principal investigator has a pre-study clinical relationship to the patient or study participant should the EMR data access changed in a clinical trial? Each institution needs to consider these and other questions when implementing EMR systems that can assist with clinical research.
In their experience, the authors clearly defined that all orders, reports, and notes that were marked as research would be removed from the legal medical record when it was printed unless reference to these results appear in the “standard” or clinical care documentation. Additionally, while physicians were encouraged to not make clinical care decisions based on the clinical research findings (except in the event of adverse events), these reports could not be suppressed in their vendor’s EMR system.
The authors advocate cooperation between organizations/institutions,”if common implementation models were developed, institutions could more easily leverage their substantial EMR investments to support prospective clinical trials and translational research” and “we urge that one effort within this agenda include the development of vendor-independent model EMR–translational research configuration descriptions that represent “best practices” and meet external regulatory requirements. An organization could then use these model descriptions and tailor them to fit local institutional policies and clinical practices.”
There are a great number of ethical, legal, and institutional policy hurdles to overcome prior to implementing a unified clinical care/clinical research EMR. However, if well-designed, there is great potential to improve human subject enrollment in clinical trials.
- Kahn, MG, Kaplan, D, Sokol, RJ, DiLaura, RP. Configuration Challenges: Implementing Translational Research Policies in Electronic Medical Records. Academic Medicine 2007; 82(7):661-669 http://www.ncbi.nlm.nih.gov/pubmed/17595562