1. Development of Standard Scripts for Analysis and Programming Working Group – White Papers Project PhUSE Webinar January 2015 Mary Nilsson 1

2. 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

3. 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

4. 4 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

5. 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)

6. Vision: Shared Reusable Code Library (Script Repository)

7. 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

8. 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

9. 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

10. Example Displays

14. 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

15. 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

16. How to Get Involved How to join the Working Group – Go to www.phusewiki.org, click “Join a Working Group”, see mailing list instructions, joinwww.phusewiki.org “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

17. Reference URLs PhUSE home: http://phuse.eu/ http://phuse.eu/ – Includes final white papers (under Publications) PhUSE Wiki: www.phusewiki.org 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 http://www.phusewiki.org/wiki/index.php?title=Standard_Scripts PhUSE Repository: – http://code.phuse.com http://code.phuse.com – https://code.google.com/p/phuse-scripts/wiki/yml_idx https://code.google.com/p/phuse-scripts/wiki/yml_idx

18. Q&A

19. Communications