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

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 Datasets Datasets Systems Lis*ngs Industry No TFL Stds PRM SDTM ADaM CDASH Standards Exist Alignment CFAST (Therapeu*c Areas)

Vision: Shared Reusable Code Library (Script Repository) FDA Industry Academia Repository: Standard SAS Validated Cloud Scripts R Studio Whitepaper Contributed Scripts Scripts

Focus Areas • Three Focus Areas, 5 acBve projects Script Repository Script Discovery and Acquisi*on (3 projects) (SDA, Rebeka Revis, TBD) Repository Content and Delivery Analyses and Display (RCD, Peter Schaefer, Gustav White Papers Bernard) (ADW, Mary Nilsson) Repository Governance and Infrastructure (RGI, Mike Carniello, Communica*on, Hanming Tu) Promo*on, Educa*on 2016 CSS: No changes in projects, some (CPE, Jared Slain and changes in project leads Wendy Dobson)

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

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

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

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 NEW: TQT White Paper – Events of Special Interest finalized just • Not started yet, Lead – Karolyn Kracht prior to CSS

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!

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)

Back-Up Slides

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.

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

Working Group Accomplishments • 5 White Papers finalized How to find final white papers: Go to – Vital Signs, ECGs, Labs - Central Tendency www.phuse.eu, Click on CS Working • Finalized in October 2013, Lead – Mary Nilsson Groups, – Non-Compartmental Pharmacokine*cs Click on CS • Finalized in March 2014, Lead - Francois Vandenhende Deliverables – Demographics, Disposi*on, and Medica*ons Catalog • 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 NEW

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!