Research Concepts

There is quite a lot of activity going on today to standardize research concepts. These are concepts typically used to assess the efficacy or safety of new drugs in clinical trials for various therapeutic areas.  TransCelerateBiopharma has teamed up with CDISC and the Critical Path Institute and launched CFAST to conduct this work. The FDA is actively engaged. Recently, a friend and colleague wrote about Research Concepts on his blog.

This is extremely important work, which helps standardize data collection and data exchange in clinical trials. My main concern is that the term "Research Concept" is too narrowly focused. These are Clinical Concepts that happen to be used in research. Why is this distinction important? The clinical concepts used in clinical trials to establish safety and efficacy are the same clinical concepts that are used in health care to determine the safe and effective use of the product for any given patient. These clinical concepts are also useful for various other use cases.

My point is, standardization of clinical concepts to support a single use case is not enough. They need to take into account other use cases, and the development process needs to incorporate these standard concepts into EHR systems, so they are available for other use cases.

Currently, the National Institutes of Health is engaged in the standardization of clinical concepts for numerous areas in medicine. These are stored and made publicly available in the NIH Common Data Elements Repository hosted by the National Library of Medicine (NLM). The Office of the National Coordinator (ONC) for Health IT recognizes the importance of incorporating standard common data elements into EHRs. The Structured Data Capture  (SDC) initiative is teaming up with the NIH to do just that.

It is not clear to me how CFAST and the NIH CDE/ONC SDC activities fit together? Are they parallel, duplicative efforts? Is there a mechanism for CFAST clinical concepts to find their way into the NIH/ONC efforts? I'm not sure. If they are parallel efforts then they need to come together somehow.

Then there is CIMI, the Clinical Information Modeling Initiative. How does that fit in?

I welcome your thoughts and perspectives.

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