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Trial Drug Administration


(Edward Palmer) #1

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!


(Vojtech Huser) #2

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.


(Anna Ostropolets) #3

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.


(Manlik Kwong) #4

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:

  1. Create custom vocabulary and concepts covering each experimental drug down to dose and form (capsule, injection, etc) modeled after existing drugs in RxNORM.

  2. 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.

  3. 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.


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