Difference between revisions of "WG5 Project 07"

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|05Sept2018 - 07Sept2018|| [http://www.wuss.org/ Western Users of SAS Software]|| Unknown || Sacramento, USA
 
|05Sept2018 - 07Sept2018|| [http://www.wuss.org/ Western Users of SAS Software]|| Unknown || Sacramento, USA
 
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|12Sept-14Sept2018||[https://www.amstat.org/ASA/Meetings/ASA-Biopharmaceutical-Section-Regulatory-Industry-Statistics-Workshop.aspx?hkey=79bb0ab7-ed56-4b48-a494-6436dd0322a6 ASA Industry Statistics Workshop]||'''7th Dec 2017'''||Washington
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|12Sept-14Sept2018||[https://www.amstat.org/ASA/Meetings/ASA-Biopharmaceutical-Section-Regulatory-Industry-Statistics-Workshop.aspx?hkey=79bb0ab7-ed56-4b48-a494-6436dd0322a6 ASA Industry Statistics Workshop]||'''Closed'''||Washington
 
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|08Oct2018-12Oct2018|| [https://www.cdisc.org/save-date-2018-interchanges CDISC US Interchange]||Unknown|| Bethesda, MD
 
|08Oct2018-12Oct2018|| [https://www.cdisc.org/save-date-2018-interchanges CDISC US Interchange]||Unknown|| Bethesda, MD

Revision as of 04:33, 3 January 2018


Project Team

Project Lead
Jared Slain and Wendy Dobson
Project Members

We need your help! Please contact a member of the working group if you would like to volunteer for this project.

Project Description

Project Name
Communication, Promotion and Education
Description
The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation.

Project Progress

Milestones
Reports

Presentations and Publications

  • November 2017 - We are pleased to announce that we have now published a video on the PhUSEtube called 'Study-Size Adjusted percentages: Why, When and What? which is presented by Brenda Crowe @ Lilly. Here's the link. Enjoy



  • Abstract Presented by Mercidita Navarro, Genetech, at the ASA Biopharmaceutical Work Shop




Upcoming Opportunities

2018

Date Event Submission Deadline Location
Throughout 2018 PhUSE Single Day Events Varies Global
4Mar2018-6Mar2018 PhUSE CSS 2018 12th Jan 2018 Silver Spring, MD (USA)
8Apr2018-11Apr2018 SAS Global Forum 2018 Closed Denver, CO (USA)
17Apr-19Apr2018 DIA Europe Unknown Basel, Switzerland
23Apr2018-27Apr2018 CDISC European InterChange 12Jan2018 Berlin
29Apr2018-2May2018 PharmaSUG 2018 Currently Open Seattle, WA (USA)
16May2018-19May2018 ASA Symposium on Data Science & Statistics Unknown Reston, Virginia
20May2018-23May2018 Society for Clinical Trials (SCT) 3rd December 2017 Portland, Oregon
3Jun2018-6Jun2018 PhUSE US Annual Conference Closed Raleigh, NC (USA)
24Jun2018-28Jun2018 DIA 2018 Unknown Boston, MA (USA)
09Jul2018-11Jul2018 CDISC Japan Interchange Unknown Tokyo
28Jul2018 - 02Aug2018 ASA Joint Statistical Meetings (JSM) Unknown Vancouver, Canada
September 2018 CDISC China Interchange Unknown Beijing
05Sept2018 - 07Sept2018 Western Users of SAS Software Unknown Sacramento, USA
12Sept-14Sept2018 ASA Industry Statistics Workshop Closed Washington
08Oct2018-12Oct2018 CDISC US Interchange Unknown Bethesda, MD
4Nov-7Nov2018 PhUSE Annual European Conference Unknown Frankfurt, Germany
Fall2018 The W Edwards Deming Institute TBC TBC

2017

Date Event Presenter Title
20Mar2017 PhUSE Computational Science Symposium Mary Nilsson and Nhi Beasley Poster: Standard Analyses and Displays for Common Data in Clinical Trials – The Journey Continues!
20Mar2017 PhUSE Computational Science Symposium Peter Schaefer, Nancy Brucken, and Cynthia Stroupe Poster: A Contribution to Better Systems – The Test Data Factory (TDF) Project
20Mar2017 PhUSE Computational Science Symposium Jared Slain Poster: A User Guide for the PhUSE GitHub Repository
20Mar2017 PhUSE Computational Science Symposium Hanming Tu and Mat Soukup Poster: Reducing Duplicated Effort on Standard Analyses through Collaboration - Roadmap for Standard Analyses and Code Sharing Working Group
13Jul2017 PhUSE North Chicago SDE NA North Chicago, IL (USA)
10Aug2017 PhUSE Whippany SDE NA Whippany, NJ (USA)
9Sept2017-12Sept2017 RAPS Convergence 28Jul2017 Washington, DC (USA)
8Oct2017-11Oct2017 PhUSE Annual Conference 28Apr2017 Edinburgh, Scotland (UK)
12Oct2017 ASA Webinar on Quantitative Sciences for Safety Monitory During Clinical Development NA Teleconference
18Oct2017 ASA Webinar on Jump-start to R for Statistical Programmers & Analysts NA Teleconference
19Oct2017 ASA Webinar on Network Analysis in Cross-sectional Data Using R NA Teleconference
14Nov2017 ASA Webinar on Regression Models for Censored Data NA Teleconference
29Nov2017 ASA Webinar on Introduction to Data Science NA Teleconference
9Nov2017 PhUSE Durham SDE NA Durham, NC (USA)
25Nov2017 PhUSE Mumbai SDE NA Mumbai, India (USA)

2016

Date Event Presenter Title
12Oct2016 PhUSE Annual Conference Jared Slain and Hanming Tu Coding Solutions paper: Get a Jump Start on Clinical Data Analysis and Visualization with Standard Scripts
11Oct2016 PhUSE Annual Conference Jared Slain and Hanming Tu CS Discussion Club
9Oct2016 PhUSE Annual Conference Adrienne Bonwick and Frank Senk Scriptathon
26Sept-30Sept2016 2016 CDISC International Interchange Nancy Brucken Standard Analyses and Code Sharing (PhUSE Computational Science Working Group)
8May-11May2016 PharmaSUG Annual Conference Dirk Spruck, Hanming Tu, and Dante Di Tommaso Poster: "The car is in the shop but where are the mechanics?" The future of Standard Scripts for Analysis and Reporting
13Mar-15Mar2016 PhUSE Computational Science Symposium Dirk Spruck, Hanming Tu, and Dante Di Tommaso Poster: "The car is in the shop but where are the mechanics?" The future of Standard Scripts for Analysis and Reporting
13Mar-15Mar2016 PhUSE Computational Science Symposium Mary Nillson and Nhi Beasley Poster: Standard Analyses and Displays for Common Data in Clinical Trials - Socialize the Deliverables!

2015

Date Event Presenter Title
11Oct-14Oct2015 PhUSE Annual Conference Dirk Spruck Scriptathon and working group update
20Sep-23Sep2015 SCDM Annual Conference Steve Wilson Working group update
27Aug2015 Standard Script Working Group - All Hands Meeting Hanming Tu & working group leads Development of Standard Scripts for Analysis and Programming working group updates
17May-20May2015 PharmaSUG Annual Conference Hanming Tu Qualification Process for Standard Scripts in the Open Source Repository with Cloud Services
17May-20May2015 PharmaSUG Annual Conference Nancy Brucken Update: Development of White Papers and Standard Scripts for Analysis and Programming
20April-22April2015 DIA/FDA Statistics 2015 Forum Mat Soukup Round Table Discussion
15Mar-17Mar2015 PhUSE Computational Science Symposium Dante Di Tommaso Poster: Qualification Process for Standard Scripts Hosted in the Open Source Repository
15Mar-17Mar2015 PhUSE Computational Science Symposium Chris Hurley Poster: Standard Scripts for Analysis and Reporting – A Vision within Reach!
18Feb 2015 PhUSE CS Working Group update Mary Nilsson Development of Standard Scripts for Analysis and Programming
8Jan2015 PhUSE CSS Working Group Update Webinar (recording available) Hanming Tu Presentation:

Development of Standard Scripts for Analysis and Programming - PhUSE Script Repository and Scriptathon Updates

8Jan2015 PhUSE CSS Working Group Update Webinar (recording available) Mary Nilsson Presentation: Development of Standard Scripts for Analysis and Programming - White Papers for Standard Analyses and Displays for Common Data Elements such as Demographics, Adverse Events, Disposition, Laboratory Measures, etc.

2014

Date Event Presenter Title
12Oct2014 - 15Oct2014 PhUSE 2014 annual conference Mike Carniello, Hanming Tu, Dirk Spruck Poster : Collaborative Development of an Open Source Repository for Standardised Analysis Using Cloud Services
12Oct2014 - 15Oct2014 PhUSE 2014 annual conference Mary Nilsson, Ann Croft, Dirk Spruck Paper: Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports Poster: Link
12Oct2014 - 15Oct2014 PhUSE 2014 annual conference Mike Carniello Presentation: Development of Standard Scripts for Analysis and Programming
29Sep2014 PhUSE CSS Standard Script Group All-Hands Meeting (update on working group progress prior to PhUSE 2014 annual conference) Mike Carniello Standard Script All-Hands meeting
10Nov2014 - 14Nov2014 CDISC Interchange Frank Senk PhUSE Standard Scripts for Analysis and Reporting
September 2014 2014 ASA Biopharmaceutical Section FDA-Industry Statistics Workshop Mat Soukup Roundtable
24Aug2014 - 28Aug2014 ISCB Mohammand Fayaz, Mary Nilsson Standardizing Safety Analyses for Clinical Trials: A Story of Success in the Making
2Aug2014 - 07Aug2014 2014 Joint Statistical Meeting Steve Wilson n.n.
3Jul2014 Basel PhUSE SDE Dirk Spruck Poster: 2014 Computational Science Symposium (CSS) Working Groups Intro & Update
15Jun2014 - 19Jun2014 DIA Annual Meeting Mary Nilsson Poster: Creating Standard Analyses and Displays for Common Safety Assessments in Clinical Study Reports
15Jun2014 - 19Jun2014 DIA Annual Meeting Hanming Tu Poster: Collaborative Development of an Open Source Repository for Standardized Analysis Using Cloud Services
1Jun2014 - 4Jun2014 PharmaSUG 2014 Nancy Brucken, Mike Carniello, Mary Nilsson, Hanming Tu Presentation: Update: Development of White Papers and Standard Scripts for Analysis and Programming
7Apr2014 - 9Apr2014 FDA/DIA Statistics Forum Qi Jiang (Authors: Mary Nilsson, Wei Wang, Qi Jiang) Poster: Analyses and Displays for Vital Signs, ECG, and Laboratory Analyte Measurements
7Apr2014 - 11Apr2014 CDISC European Interchange Hanming Tu Open Source Repository in the Cloud - FDA/PhUSE CSS Standard Script Working Group
17Mar2014 Phuse CSS 2014 Wei Wang & Mary Nillson Poster: PP01 - PhUSE CSS White Paper on Analyses and Displays Associated with Outliers/Shifts from Normal to Abnormal
17Mar2014 Phuse CSS 2014 Mary Nilsson, Wei Wang & Qi Jiang Poster: PP03 - PhUSE CSS White Paper on Analyses and Displays Associated with Central Tendancy
17Mar2014 Phuse CSS 2014 Simin Baygani Poster: PP07 - PhUSE CSS White Paper on Analyses and Displays Associated with Demographics, Dispositions and Medical History
17Mar2014 Phuse CSS 2014 Francois Vandenhende, Ingrid Burton, Sascha Ahrweiler, Vincent Buchheit Poster: PP15 - PhUSE CSS White Paper on Analyses and Displays Associated to Pharmacokinetics - with a Focus on Clinical Trials
17Mar2014 Phuse CSS 2014 Sheryl McCoy, Qi Jiang, Mary Nilsson Poster: PP17 - PhUSE Computational Science Symposium (CSS) White Paper on Analyses and Displays Associated with Adverse Events
17Mar2014 Phuse CSS 2014 Terry Walsh Poster: PP20 - PhUSE CSS White Paper on Analyses Associated with Hepatotoxicity
08Jan2014 CSS Preview Webex Stephen E Wilson /Hanming Tu PhUSE/CSS Webinar: Standard Script Group

2013

Date Event Presenter Title
15Oct2013 PhUSE 2013 Lina Ulkjær Jørgensen Call for scripts and get involved with FDA/PhUSE Scripts Repository
15Oct2013 PhUSE 2013 Ingrid Burton Pharmacokinetics standardization: patients’ healthcare is becoming central
26Sep2013 PhUSE SDE Hanming Tu FDA/PhUSE CSS Working Group - Open Code Repository
5Aug2013 JSM 2013 Michael Carniello Pharmaceutical Users of Software Exchange (PhUSE) - a quick overview
June2013 ICSA 2013 Qi Jiang Development of Standard Scripts for Analysis and Programming -Overview

Publications

Planned Publications

Date Medium Author Title Submission Deadline Status

2017

Date Medium Author Title Version
17Mar2017 PDF Script Discovery and Acquisition Project Team Screen Shots of the Displays Created by JumpStart Programs 1.0
17Mar2017 Word Script Discovery and Acquisition Project Team Screen Shots of the Displays Created by JumpStart Programs 1.0
02Mar2017 PDF Analysis and Display White Papers Project Team Analysis and Displays Associated with Adverse Events: Focus on Adverse Events in Phase 2-4 1.0
02Mar2017 Word Analysis and Display White Papers Project Team Analysis and Displays Associated with Adverse Events: Focus on Adverse Events in Phase 2-4 Clinical Trials and Integrated Summary Documents 1.0

2016

Date Medium !! style="width:35%" | Author Title Version
03Nov2016 PDF Analysis and Display White Papers Project Team Analyses and Displays Associated with Thorough QT/QTc Studies 1.0
03Nov2016 Word Analysis and Display White Papers Project Team Analyses and Displays Associated with Thorough QT/QTc Studies 1.0

2015

Date Medium Author Title !! style="width:10%" | Version
09Oct2015 PDF Analysis and Display White Papers Project Team 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 1.0
09Oct2015 Word Analysis and Display White Papers Project Team 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 1.0

2014

Date Medium Author Title Version
25Mar2014 PDF Analysis and Display White Papers Project Team Analyses and Displays Associated to Non-Compartmental Pharmacokinetics – With a Focus on Clinical Trials 1.0
10Jul2014 PDF Analysis and Display White Papers Project Team Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents 1.0
10Jul2014 Word Analysis and Display White Papers Project Team Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinical Trials and Integrated Summary Documents 1.0

2013

Date Medium Author Title !! style="width:10%" | Version
10Oct2013 PDF Analysis and Display White Papers Project Team 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 1.0
10Oct2013 Word Analysis and Display White Papers Project Team 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 1.0

Action Items

  • Implement Team (we need Writers, Networkers, Twitters)
  • "Something big" for 2017!
  • Increase visibility of White Papers and code repository on the PhUSE website
  • Create a video on PhUSE Tube how to work with the repository
  • Gain greater access to other interest groups
  • Inspire discussions & participation
  • Present progress at conferences
  • Formal publication of White Papers

Group Meetings

Date Topic Minutes
22Nov2017 November Meeting (Potpourri of items) Minutes
26June2017 Something Big - June Meeting Minutes
10May2017 Kickoff for Something Big Minutes


Last revised by WendyDobson,01/3/2018