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Notes and Commentary from the CDISC PopPK ADaM Subgroup


#1

Hi, my name is Dave Radtke, I co-chair the current working committee within CDISC focused on development of guidelines and standards for population PK and PK/PD datasets with a focus on the creation of ADaM standards for datasets. I will post presentations and discussion topics here from time to time for review and comments. Thank you in advance for your thoughts and input.


#2

Dave

Much thanks…The work that the CDISC group does in this regard will be be extremely beneficial, and this forum can act as a great resource for bouncing ideas off of the broader community.


#3

Notes from first meeting, 06-Apr-16
(sorry, I do not have permission to upload files yet, here is some summary slide content):

Opportunities for Exploration

  • Rules
    - How to implement ADDL/II
  • Definitions
  • Common Processes
    - Sequence/order of data combination
    - Exclusions?
  • Early analysis
    - Rules, guidelines, blinding
    - How does that differ between companies

Additional Thoughts

  • Standard datasets are not intended to force a standard analysis, however, to restrictive of a format may be perceived as forcing an analysis preference

  • A possible solution would be to drive to a high level guidance, then move toward specific tool standards

  • Do standard tools need to adapt to a data standard as opposed to the data standard fitting all tools?

  • What does the agency(agencies) really need? How do they really review our data/analysis?

  • How do things differ between the FDA, EMA, PMDA, HCA, Other countries`
    
  • What are various companies currently submitting?

  • Standards

      - Data standards (data types, rules around nomenclature, implementation)
      - Rules (data handling, exclusion, data correlation)
      - Workflow (may be difficult)
    

Moving forward

  • Team decided to meet bi-weekly

  • May try and divide efforts between ISOP groups and CDISC

  • The goal should be both a high level standard and specific ADaM standard files maybe more focused on a specific program’s requirements.

  • Need to look at how population PK program needs fit within existing ADaM standards

    • i.e., what does an ADaM dataset look like compared to a standard NONMEM dataset

#4

@DBRadtke

you should have permissions to upload materials should you need to.