Transcript Title

Development of Standard Scripts for
Analysis and Programming Working Group –
White Papers Project
PhUSE Webinar
January 2015
Mary Nilsson
1
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
Working Group Leadership
• 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)
4
Vision: Fill the Gap on
Analysis Standards
Clinical Data
Flow
Industry
Standards
Alignment
Trial
Design
Data
Collection
Systems
PRM
CDASH
TransCelerate (TAs)
Observed
Datasets
Analysis
Datasets
SDTM
ADaM
Tables,
Figures
and
Listings
No TFL Stds
Exist
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
Example Recommendations
• 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
Help Wanted
• 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
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