Kick Off for Something BIG

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When: 11:00 EST, 10May2017
Place: Webinar
Facilitator: Jared Slain
Scribe: Jared Slain
Attendance: Jared Slain, Mary Nilsson, Steve Wilson, Mat Soukup, Kerry Robson (filling in for Wendy Dobson)
Absent: Brenda Crowe, Nhi Beasley, Hanming Tu, Ian Fleming, Wendy Dobson
Agenda: Something big for Analysis and Display White Papers

Statement of problem

  1. Whitepapers = community consensus of best way to analyze and visualize data
  2. People need to learn what’s in the whitepapers so that goal of industry-standardization is achieved
  3. Communication is what we’ve done (and will continue to do) to help people be aware, but we also need to educate so that people understand.

Intended audience

  1. Physicians/Medical Reviewers
  2. Regulatory Affairs
  3. Biostats/Stat programmers

Ideas from CSS Brainstorming session

  1. Present at conferences (not just stats-related, but DIA, RAPS, etc.)
  2. Half-day webinar
  3. Guest presentations at college Biostatistics classes
  4. Have people present directly to Pharmaceutical companies, CROs, etc.
  5. Have whitepapers education be part of onboarding at FDA and at companies/CROs

Whitepapers to focus initial education efforts on

  1. Treatment Emergent Adverse Events (Webinar in Fall 2017)
  2. Labs & Vitals (Timing of a webinar TBD)

Action Plan (Definition of “Something Big”)

  1. Series (2-4) of 10 minute YouTube clips
    a.Possible topics include Consolidated Terms and "After Dose" definition
    b. Nicely done, possibly using Camtasia software, may need to recruit someone with video editing skills
    c. Timeframe: begin work ASAP
  1. Series (2-4) of 1 hour webinars
    a. Possible topics include AE Whitepaper, Dropouts
    b. Work with ASA Biopharm & DIA instead of “just PhUSE”
    c. Timeframe: Fall 2017
  1. Slides for ½ day workshop
    a. Ideally, would provide some sort of Continuing Education credit
    b. Topic includes not just what plots are but how to interpret them
    c. Presented at multiple places, possibly by multiple personnel (FDA, NIH, 2018 PhUSE CSS Sunday, Schools of Pharmacy, Future inclusion on MCATS?)

Individual Action Items

  1. Jared – Find someone with video editing skills possibly in collaboration with Ian
  2. Mary – Coordinate as necessary with ASA Biopharm; Add Safety in Rare Diseases as a possible white paper
  3. Steve/Mat – Coordinate as necessary with FDA training program
  4. Wendy – Schedule webinars as necessary
  5. Brenda – Absent from meeting but has a big interest in project, specifically in presenting the material

Last revision by WendyDobson,06/22/2017