Could I ask what concept people typically use for the administration of a trial drug? We are ETLing from an EHR and so these drugs are blinded on the system. The only values I can find are either of the wrong domain, or invalid.
Thank in advance!
It seems to be a gap in conventions.
This is related to: will there ever be code for placebo and subtypes for placebo or a code for active-drug-or-placebo. Post the codes you considered.
There is a code for placebo, but nothing for an unknown/blinded ingredient. I guess a custom code (e.g. 2000000000) would work. I can hardly imagine the scenario where we would want to do a network study on ‘any unknown investigational drug’.
We can add a generic ‘investigational substance’ ingredient, if the community feels like so. On the other hand, once you have many investigational drugs that you want to distinguish, it gets messy.
I am dealing this issue in the following approach in the context of a multi-site/OMOP, multi-arm, multi-experimental drug comparative effectiveness trial where there isn’t RXNORM or other vocabularies to code these drugs to. My thinking is:
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Create custom vocabulary and concepts covering each experimental drug down to dose and form (capsule, injection, etc) modeled after existing drugs in RxNORM.
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Map and import patient care record data - survey as well as experimental drug concepts into our OMOP warehouses - here we want to link and provide a consistent way of utilizing the patient’s past medical history contained in the EHR. Meaning integration of experimental PCR data with EHR data within a CDM.
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At some point in time, if the experimental drug becomes a FDA approved medication and makes its way through inclusion into standard vocabularies - then run an OMOP patch program to re-assign the custom experimental drug concept code to the new RxNORM code.
The above can utilize Anna’s suggestion of including which patient received placebo.