Aug 4, 2016 Meeting Notes

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Meeting minutes of Nonclinical_Script_Assessment_Project

Aug 4, 2016

Present First Name Last Name Affiliation
Yes Kevin Snyder FDA
Elaine Thompson FDA
Yes Kevin Cahill EPL
Bill Varady Boehringer-Ingelheim
Yes Bob Dorsam FDA
Bob Friedman Xybion
Chris Eley Pfizer
Stephen MacMannis Pfizer
Fred Mura PDS
Yes Hanming Tu Accenture
Yes Bill Houser Bristol-Myers Squibb
Carol Gleason Bristol-Myers Squibb

Action Items from previous meeting:

  • Bill Houser is still working through his internal company the process to share a couple SAS scripts.
  • Fred Mura will check academic contacts to see if there is interest in R or SAS programming.
  • Elaine will check for Toxicology areas and contacts at George Washington University

Notes from previous coding meeting:

  • Kevin Snyder found that to analyze the PDS data we need to look at PCTPTNUM to get the hour after dose, but this doesn't work with the Instem dataset. For the Instem script we need PCELTM and PCRFTDTC. He suggested it would probably be worth enabling the script to work with either dataset.
  • We should each try the script on our own data and share the results

Notes from this meeting:

  • Responding to Vendor Concerns:
    • Our team's key motivators for participation are
      • Learn R <- key!
      • To enable us to immediately adjust analysis tools to get faster access to data interpretation (custom analysis)
      • To provide a starting point for others with their custom analysis tools.
      • Creating tools usable by non-programmers is not a motivator for many participants. If we must exclude this from our scope, the participants are still motivated to participate.
    • Additional motivators are
      • A place for programmers to get together and determine high value items
      • List of script ideas, to help prioritized
      • Evaluate clinical scripts and their applicability to non-clinical
      • Define script requirements for scripts with FDA reviewer input and publish the results.
    • Our short term goals:
      • A key value we can deliver is a library of functions to get the data ready for analysis
      • Review the clinical scripts
      • As part of the review, identify library functions that can be created and make them.
  • We should reach out to Pinnacle 21 to join us - Bill will reach out to them to see if they could join the meeting after next.
    • Their experience would help us
    • They could benefit from our contributions