Development of Standard Scripts for Analysis and Programming PhUSE - - PowerPoint PPT Presentation

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Development of Standard Scripts for Analysis and Programming PhUSE - - PowerPoint PPT Presentation

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Development of Standard Scripts for Analysis and Programming PhUSE Webinar CSS Debrief 27 April 2016 Vision: Fill the Gap on Analysis Standards Tables, Data Clinical Data Figures Trial Observed Analysis Collec*on Flow and Design

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PhUSE Webinar – CSS Debrief 27 April 2016

Development of Standard Scripts for Analysis and Programming

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Vision: Fill the Gap on Analysis Standards

Data Collec*on Systems Observed Datasets Analysis Datasets Tables, Figures and Lis*ngs

Clinical Data Flow

Trial Design

PRM SDTM ADaM

No TFL Stds Exist Industry Standards Alignment

CDASH

CFAST (Therapeu*c Areas)

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Vision: Shared Reusable Code Library (Script Repository)

Repository: Standard Validated Scripts

Industry FDA Academia

R Studio SAS Cloud

Whitepaper Scripts Contributed Scripts

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Focus Areas

  • Three Focus Areas, 5 acBve projects

Script Repository (3 projects) Analyses and Display White Papers

(ADW, Mary Nilsson) Communica*on, Promo*on, Educa*on (CPE, Jared Slain and Wendy Dobson)

Script Discovery and Acquisi*on (SDA, Rebeka Revis, TBD) Repository Content and Delivery (RCD, Peter Schaefer, Gustav Bernard) Repository Governance and Infrastructure (RGI, Mike Carniello, Hanming Tu)

2016 CSS: No changes in projects, some changes in project leads

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2016 CSS – What We Did

  • Github Workshop (Monday night)

– Crea*ng and Edi*ng Scripts in Github – Approximately 20 Par*cipants – Exercises available in GitHub, both as text and screenshots

  • Met with the Analysis Results and Metadata

Project Team (from Seman*c Technology WG)

– Star*ng a collabora*on – Dante Di Tommaso volunteered to be the liaison

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2016 CSS – What We Did

  • Script Repository Break-Out Sessions

– Reviewed Git and Github – Reviewed qualifica*on process – Reviewed scripts that are part of FDA’s JumpStart service

  • Addi*onal scripts received from the FDA – Added to the Script

Repository prior to the CSS – Reviewed the front-end of repository – index page – Discussed naming conven*on, version control – Discussed goals

  • White Papers Break-Out Sessions

– Discussed displays associated with adverse events, hepatotoxicity, and ques*onnaire data

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Working Group Next Steps

  • Con*nue work on the Script Repository

– Develop and present Central Tendency package moving through the qualifica*on process – Develop and present tradi*onal vs analysis result metadata driven program using central tendency – Refine goals and discuss working model

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Working Group Next Steps

  • Con*nue work on white papers

– Adverse Events

  • Working on Dra] 2 for public review, Lead – Sheryl Treichel

– Hepatotoxicity

  • Working on Dra] 1 for public review, Lead – Terry Walsh

– Ques*onnaire Data

  • Working on Dra] 1, Lead – Karin LaPann

– Events of Special Interest

  • Not started yet, Lead – Karolyn Kracht

NEW: TQT White Paper finalized just prior to CSS

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Working Group Next Steps

  • Con*nue work on Communica*on, Promo*on,

Educa*on

– Develop training material – Possible webinar on the available scripts that are part of FDA’s JumpStart service – We need you to help socialize the deliverables!

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Working Group Next Steps

  • Thinking about a few new projects

– Specifica*ons/mapping between white papers and scripts – Crea*on of test data – Best prac*ces for collec*on instruc*ons (e.g., AEs, medica*ons, disposi*on)

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Back-Up Slides

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How to Participate

  • Sign up for the PhUSE working group mailings

– From phusewiki.org, click “Join a Working Group Now” – Standard Scripts Groups

  • CSS-WG-Standard-Scripts (En*re Working Group)
  • CSS-WG-Standard-Scripts-WhitePapers (White Paper Project Team)
  • CSS-WG-Standard-Scripts-Plagorm (Script Repository)
  • CSS-WG-SS-WhitePaperReviewers (No*fied when a white paper is

ready for review)

  • See wiki pages for each of the projects (www.phusewiki.org)

– Wiki pages include links to final white papers, dra] white papers, repository, etc.

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Working Group Accomplishments

  • Script Repository has been created

– Started in Google Code, now in GitHub – MIT license chosen – Process guidelines developed – Qualifica*on guidelines developed – User-friendly front end developed

  • Scripts exist in the repository

– 5 Scriptathons resul*ng in several scripts at various stages

  • Focused on crea*ng scripts associated with the displays in the white papers

– Received scripts that are part of FDA’s JumpStart service

  • A couple last year, addi*onal scripts this year

NEW

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Working Group Accomplishments

  • 5 White Papers finalized

– Vital Signs, ECGs, Labs - Central Tendency

  • Finalized in October 2013, Lead – Mary Nilsson

– Non-Compartmental Pharmacokine*cs

  • Finalized in March 2014, Lead - Francois Vandenhende

– Demographics, Disposi*on, and Medica*ons

  • Finalized October 2014, Lead – Simin Baygani

– Vital Signs, ECGs, Labs – Outliers and Shi]s

  • Finalized in September 2015, Lead – Wei Wang

– QT Studies

  • Finalized in March 2016, Lead – Christos Stylianou

How to find final white papers: Go to www.phuse.eu, Click on CS Working Groups, Click on CS Deliverables Catalog NEW

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Working Group Needs

  • More project team members
  • Par*cipate in re-usable code development

– Write, Test, Qualify, Review, Improve

  • Increased par*cipa*on in white paper reviews – Help recruit!
  • Use/reference recommenda*ons in exis*ng final white papers!

– Forward to any exis*ng standards groups – Link to white papers from Sta*s*cal Analysis Plans

  • Keep eyes open for exis*ng scripts that need a public home
  • Adver*se! Adver*se! Adver*se!