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Transcript of Development of Standard Scripts for Analysis and Programming Working Group – White Papers Project...
Development of Standard Scripts for Analysis and Programming Working Group –
White Papers Project
PhUSE WebinarJanuary 2015Mary Nilsson
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The Big Picture
PhUSE Computational Science Working Groups
Optimizing Use of Data Standards
Standard Scripts for Analysis and
Reporting
White Papers Project
Script Repository (4 Projects)
Communications Project
Emerging Technologies
Semantic Technologies Non-Clinical
Working Group Description
• Goal: Establish a platform for the collaborative development of program code to be used as analytical tools for clinical trial research, reporting, and analysis– Includes recommendations for analyses, tables,
figures, and listings– Process and guidelines for documentation and
management of scripts– Harness data standards whenever feasible
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• Current Leadership– Hanming Tu (Project Management)– Mary Nilsson (Industry co-lead, Steering Committee
Liaison)– Steve Wilson (FDA Liaison)– Mat Soukup (FDA Liaison)– Adrienne Bonwick, Mike Carniello, Sally Cassells,
Jean-Marc Ferran, Aiyu Li, Dirk Spruck, Eric Sun, Dante Di Tommaso (Project leaders)
Working Group Leadership
Vision: Fill the Gap on Analysis Standards
Data Collection Systems
Observed Datasets
Analysis Datasets
Tables, Figures
and Listings
Clinical Data Flow
Trial Design
PRM SDTM ADaM No TFL Stds Exist
Industry
Standards
Alignment
CDASH
TransCelerate (TAs)
Vision: Shared Reusable Code Library (Script Repository)
PhUSE Computational Science Working Groups
Optimizing Use of Data Standards
Standard Scripts for Analysis and
Reporting
White Papers Project
Script Repository (4 Projects)
Communications Project
Emerging Technologies
Semantic Technologies Non-Clinical
White Papers Project
• 3 white papers finalized– Vital Signs, ECGs, Labs - Central Tendency
• Finalized in October 2013
– Non-Compartmental Pharmacokinetics• Finalized in March 2014
– Demographics, Disposition, and Medications• Finalized October 2014
White Papers Project
• 2 white papers out for broad review– Vital Signs, ECGs, Labs – Outliers/Shifts– Adverse Events– Comments due 16 January 2015
• 2 white papers in progress– Hepatotoxicity– QT Studies
• 2 white papers planned– Analyses and Displays Associated with Questionnaire Data– Analyses and Displays for Events of Special Interest
Example Displays
Example Displays
Example Displays
Example Displays
• Measurements after stopping medication– Generally exclude, even for drugs with a long half-life
• Unplanned measurements– Generally exclude for central tendency analyses/displays,
include for scatterplot, shifts
• Units– May need both SI and CN units
• P-values and confidence intervals– Did not take a position, but provided a discussion
Example Recommendations
• White Papers– Review draft white papers, spread the word to elicit
additional reviewers (include your medical colleagues)– Spread the word on the final white papers– Implement the recommendations!– Need medical writing support
Help Wanted
How to Get Involved
• How to join the Working Group– Go to www.phusewiki.org, click “Join a Working Group”, see mailing list instructions,
join • “CSS-WG-Standard-Scripts” (Working Group), and/or • “CSS-WG-Standard-Scripts-WhitePapers” (White Papers Project), and/or • “CSS-WG-Standard-Scripts-Platform” (Repository Project), and/or • “CSS-WG-SS-WhitePaperReviewers” (not joining but will be notified when a white paper is
ready for review)
• How to review a white paper– Go to the PhUSE website, Computations Science (CS) Working Group (WG) section,
CS Deliverables Under Review tab to see all deliverables under review• http://www.phuse.eu/cs-deliverables-under-review.aspx
– Or, go to the PhUSE CS WG Standard Scripts wiki page, White Papers project pages• http://www.phusewiki.org/wiki/index.php?title=WG5_Project_08
Reference URLs
• PhUSE home: http://phuse.eu/
– Includes final white papers (under Publications)• PhUSE Wiki: www.phusewiki.org
– Includes process and qualifications guidelines, draft white papers
• PhUSE Standard Script Group: http://www.phusewiki.org/wiki/index.php?title=Standard_Scripts
• PhUSE Repository: – http://code.phuse.com– https://code.google.com/p/phuse-scripts/wiki/yml_idx
Q&A
Communications
• Communications