Consider Medical Coding During the Clinical Trial Study Build
I’ll be honest, medical coding clinical trial data is a time-consuming job requiring attention to detail that some might describe as tedious. However, it is critically important in ensuring the data collected as a part of clinical trials can be quickly analyzed for results and insights.
As clinical data arrives from around the world, clinical data managers begin to review the data and ensure it is in a standardized format. Oftentimes in global multi-center clinical trials, the medical and scientific data has been recorded in various ways and not in a standardized format. If this is the case, data managers will query the study sites in order to understand the data and correctly code it. It can take study sites a considerable amount of time to respond to queries, thus slowing down the data cleaning process.
Novel approach: Incorporate medical coding into study build
Sponsors are looking for ways to speed up their clinical trial processes so that new products and expanded uses of approved products can be marketed sooner. An important way to speed up clinical trial processes is to think about medical coding during the study build phase.
Two recommendations for incorporating medical coding into the study build phase include:
Capturing data in a standardized fashion–While building the case report form (CRF) think about the end result and what information you want to collect from the trial. Use this to guide what data to collect on the CRF. Also, at this point determine the medical coding dictionary that will be used to capture adverse events (AE), medical history (MH), concomitant medications (CM), etc. Ensure the CRF is aligned with the appropriate dictionary.
The MedDRA and WHO-DDE medical dictionaries are the most widely used, and for more information on medical coding processes, please see this article by Deven Babre.
Develop coding guidelines–Determine with the study team and data managers a process for coding clinical trial data before the trial begins. Outline from the study protocol a guideline for how the study data will be handled, what the coding process will be, and when queries will be sent to study sites for clarification and to ask for the eCRF to be updated. The process of developing the coding guidelines may uncover changes that need to be made and it is much easier to do so during the study build phase.
The importance of medical coding is underestimated. Coding is an on-going process throughout the life of the trial, which can identify trends in how the data is captured. Identifying these trends early in the trial enables sponsors to work with study sites to correct these errors sooner and to reduce the likelihood the errors will continue.
It is a novel thought, but thinking about medical coding during the study build phase will ensure clinical trial data is captured in a manner that will speed up data collection, data cleaning, and eventually database lock.
I’d like to hear your thoughts. Is your company, or clinical trial partner, thinking about medical coding during the study build phase? If so, please share your experiences. If not, what hurdles are keeping this from happening?
Guest Blog by Krista Mullen
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