FDA-NIH Want Your Input on a New Resource for Terminology in Clinical Research

Consider the tomato. Or as some would call it, the “tomahto.” The whole tomato-tomahto debate has entered the language as an example of a difference so small, it doesn’t change anything.  For example, people will generally know what you are referring to no matter how you pronounce it.  But what if one group of people thought a tomato was a red plant suitable for making delicious curries and burger toppings, while other thought a tomahto was a green fruit only found in the southern Australia?  This misunderstanding would certainly cause some considerable confusion at the family barbeque.

I choose the example above since it provides a good analogy for a problem that NIH and FDA have identified in the clinical research space: critical terms are not being used consistently across the clinical research landscape.  This is specifically problematic when discussing innovative clinical trial designs and certain studies using real world data to generate real world evidence. What are some of the perils of having a modern-day Tower of Babel when it comes to clinical research? For starters, if different words mean different things to people, and are operationalized differently in different trials, how can we compare results from or pool data from different trials?   Inconsistent usage of terms can also pose specific challenges in understanding the intended meaning and impact of terms.  Problems from inconsistently terms can also cause major headaches when trying to describe a study design, communicating the goals of a planned study, or interpreting and describing research results.

To avoid the pitfalls that inconsistent use of terms can lead to, NIH and FDA created an inter-agency team of experts to study the issue and develop a resource that could be used to assist the research community in effectively communicating about clinical trials.  As a result of the team’s efforts, NIH and FDA have released a glossary of terms related to clinical research for public comment.  Right off the bat, we should make clear that this glossary is not intended to cover the entire landscape of clinical research.  The glossary contains 37 terms the team identified as being inconsistently used within the scientific community. 

The NIH and FDA are most interested in hearing community feedback on the utility of the glossary in its goal of promoting effective communications.  In addition, we want to hear from you about how we did.  Did we leave any words out that we should have included? Did we include any words that aren’t necessary?  Comments on the draft glossary will be accepted until June 24, 2024.  For more information, including how to view the glossary and how to provide comments, please visit: https://osp.od.nih.gov/comment-form-fda-nih-resource-on-terminology-for-clinical-research/

The NIH and the FDA encourage all interested parties to review the glossary and provide feedback to ensure the glossary meets its directed effect. Having a resource that defines these often inconsistently used terms will help ensure that valuable clinical research is not lost in translation.

Lyric Jorgenson, PhD
NIH Associate Director for Science Policy
About Lyric

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