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New working group: Clinical Trials

(Shawn Dolley) #1

Hey All,
Announced in today’s Tue call, I am going to lead a new working group for Clinical Trials.
First step will be to get interested parties, and figure out what use cases in clinical trials can be done with OHDSI tools… feasibility analysis? data collection? observational analysis using the data? merging it? adaptive trials and bayesian statistics? other?
We will have 2 calls a month. Please ping me here or shawn@shawndolley.com

I used the dormant ‘Clinical Study’ wiki group, details there below.

Exciting and fun!!

(Vojtech Huser) #2

Please count me in.

The existing group was not meeting regularly but we were making some progress.

E.g., this pending themis proposal https://github.com/OHDSI/Themis/issues/37 Perhaps for people who want to join, commenting on that proposal would be a great first step (taking only few minutes).

It is named clinical study because we want to include observational studies (and registries (and registry studies using OMOP format)).

See this great discussion paper from EMA referenced from here: https://en.wikipedia.org/wiki/Real_world_data#EU_context

(Shawn Dolley) #3

Thanks Vojtech. Maybe we need two groups. Personally, I think registries could be a whole group by itself, with specific issues, data needs, governance, usage in multiple types of research. Same with interventional study/ experiment vs observational. I am trying to create a working group to focus on clinical trials only with no need to accommodate additional features, definitions, etc that might be needed to enfranchise other study types. I didn’t read the themis link since I suspect based on this note you or governing people could decide what to do here… happy to rename this back to Clinical Study and create a de novo WG entry in the Wiki.

(Chris Roeder) #4

Please include me. I’m still working with completed studies (ab)using OMOP as a way to merge them, or at least represent them consistently.


(Shawn Dolley) #5

Thank you! Welcome. Can you tell me where you work or send me link to you on LinkedIn? Will keep you posted.

(Shawn Dolley) #6

All - the 1st meeting of (revived) Clinical Trials WG came off Friday, we had 5+ attendees. Log of meeting will be posted to wiki and future meetings will be recorded as is the protocol. Still working out what we will do and cover. To be added to the invite, please email me your direct email address…

(Maxim Moinat) #7

Brief overview of proposals from our presentation today:

  • Trial visit (Vocabulary extension)
    Add visit concepts specific for trials, like Baseline, Screening, Follow-up, Cycle #
  • Study (CDM extension)
    Table with study and arm metadata and assignment of persons to a study/arm.
  • Measurement modifiers (CDM extension)
    Table like the fact_relationship table that connects a fact (e.g. condition_occurrence_id) to a concept_id. This allows for a flexible way of connecting more attributes to a record. This proposal is based on the modifier domain in the tranSMART data model

OMOP CDM and Clinical Trials
(Shawn Dolley) #8

So sorry I missed this! Was this recorded?

(Maxim Moinat) #9

Hi Shawn, sorry to say that we have no recording. We will share notes and the presentation asap.