Development of Standard Scripts for Analysis and Programming PhUSE Annual Conference October 2014 Mike Carniello 1

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

3 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)

Focus Areas Three Focus Areas, 6 active projects Script Repository (4 projects) White Papers on Analyses and Displays (1 project) Communications (1 project) Existing Scripts Qualification Steps Platform Legal Considerations

Accomplishments Script Repository has been created – Google Code chosen as the repository – 3 Scriptathons – 12 scripts exist in the repository, more to come – MIT license chosen – Process guidelines developed – Qualification guidelines developed – First contributed script added to the repository – User-friendly front end developed

Script Repository Front End

Accomplishments White Papers – 3 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

Accomplishments White Papers – 2 just sent for broad review – Vital Signs, ECGs, Labs – Outliers/Shifts – Adverse Events – Comments due 01 December 2014 White Papers – 2 in progress – Hepatotoxicity – QT Studes

Accomplishments Communications

Continue to build Script Repository – Continue creating code for tables, figures, and listings as outlined in white papers (including more Scriptathons) – Consider code for SDTM and ADaM development – Look for other existing code – Enhance process and qualification guidelines – Enhance legal documentation Continue white paper development – Finalize white papers in progress – Consider additional white papers to develop (Questionnaire data? Additional safety special topics? Narratives?) Communications – Continue presentations at various conferences – Implement other ideas to increase awareness Plans for Upcoming Year

Help enhance process and qualification guidelines Communications Project – help maintain conference deadlines and links White Papers Project – medical writing support Help Wanted – Working Group

Script Repository – Actively contribute code – Use the existing code! 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! Communications – Help spread the word Help Wanted - General

Interested In Learning More? Two posters at this conference Sign up for the PhUSE working group mailings – Go to click “Join a Working Group”, see mailing list instructions, join “CSS-WG-Standard- Scripts” Sign up to be a contributor or committer in the Script Repository – Google account required – Send an to one of the repository maintainers to request to join the Google Code PhUSE/FDA script repository – Go to repository at and start interactinghttps://code.phuse.com

Reference URLs PhUSE home: – Includes final white papers (under Publications) PhUSE Wiki: – Includes process and qualifications guidelines, draft white papers PhUSE Standard Script Group: PhUSE Repository: – –

Q&A