Standard Analyses 'Deliverables & Key Links'

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  • Video:
    • Study-size adjusted percentages. Why, when & what? Brenda Crowe PhD, Senior Research Advisor, Global Statistical Sciences, Eli Lilly.
    • Script Metadata for Sharing. Why, what and how to describe and access scripts in Github repository using technologies of YML, R, R shiny and R package. Hanming Tu, VP of IT, Frontage laboratories.
  • Published Whitepapers:
    • Screen Shots of the Display created using Scripts contributed by the FDA Version 1.1: 23-May-17 (PDF Version,Word Version)
    • Adverse Events White Paper Version 1.0: 03FEB2017 (PDF version,Word version)
    • Analyses and Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents 10Oct2013 (PDF Version, Word version)
    • Analyses and Displays of PK 25Mar2014
    • Analyses & Displays Associated with Demographics, Disposition, & Medications in Phase 2-4 Clinical Trials & Integrated Summary Documents (Version 2.0: 02-Mar-18: Doc ID: WP003: PDF, Word)
    • Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Summary Documents 10Sep2015 (PDF Version, Word version)
    • Analyses and Displays Associated with Thorough QT/QTc Studies 11Mar2016 ('PDF' Version,Word version)
  • Archived publication
    • Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinnical Trials and Integrated Summary Documents 07Oct2014 (PDF Version, Word version)
  • Script Repository:

News

  1. PhUSE Deliverables
  2. 02 May 2017: Mary and Hanming gave a webinar to ASA: [ASA presentation] and [Recording]
  3. February 2017: The Adverse Events White Paper was finalized. The final copy is in the PhUSE Deliverables Catalog
  4. 25 August 2016: Draft 2 of the Adverse Events white paper is available for review until 14 October 2016. See[white paper wiki page] for instructions on how to participate in the review.
  5. 11 May 2016: We renamed this working group from Development of Standard Scripts for Analysis and Programming to Standard Analyses and Code Sharing.
  6. 10 Sep 2015: Final white paper version 1.0 of white paper on Outliers or Shifts from Normal to Abnormal: File:CS WhitePaper OutliersShifts v1.0.pdf
  7. 27 Aug 2015: All-hands meeting [slides]
  8. 09 Oct 2014: Draft 1 of the Adverse Events white paper is available for review until 01 December 2014. This review is a partial draft intended to get initial feedback on the proposed tables and figures. See the [white paper wiki page] for instructions on how to participate in the review.
  9. 07 Oct 2014: Version 1 of the Demographics/Disposition/Medications white paper has been finalized and available on www.phuse.eu (Publications section). The white paper is also available from the [CSS Catalog of Deliverables].
  10. 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
  11. 26 June 2014: Draft White Paper Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Submission Documents is available for review until 8 August 2014.
  12. 25 March 2014: Version 1 of PK white paper is available Analyses and Displays Associated to Non-Compartmental Pharmacokinetics – with a Focus on Clinical Trials.
  13. 18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: CSS conference
  14. 10 October 2013: The Central Tendency White Paper has been finalized!
  15. 26 June 2013: Hackathon_notes_20130626 are posted
  16. 01 May 2013: Individual Contributor License Agreement (Draft)
  17. FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
  18. The final draft of PhUSE Standard Scripts Update (Date Published: March 1, 2013)
  19. User Guide for Standard Script Repository has been drafted. (Date Published: February 28, 2013)
  20. The first Call for Scripts has been issued and a press release issued.
  21. GitHub has been chosen for our repository.