WG5 Project 08

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Project Deliverables

Six white papers from this project team are available. Final white papers can be found by going to www.phuse.eu, then click Working Groups, then click CS Deliverables Catalog.

  • Vital Signs, ECGs, Labs - Central Tendency Finalized in October 2013, Lead – Mary Nilsson
  • Non-Compartmental Pharmacokinetics Finalized in March 2014, Lead - Francois Vandenhende
  • Vital Signs, ECGs, Labs – Outliers and Shifts Finalized in September 2015, Lead – Wei Wang
  • QT/QTc Studies Finalized in March 2016, Lead – Christos Stylianou
  • Adverse Events Finalized February 2017, Lead – Mary Nilsson, Nhi Beasley, Sheryl Treichel
  • Demographics, Disposition, and Medications version 2.0 Finalized March 2018, Lead – Simin Baygani

Project Team

Project Lead
Mary Nilsson
Project Members
Wei Wang, Simin Baygani, Qi Jiang, Jack Shostak, Frank Senk, Harprit Dosanjh, Musa Nsereko, Fabien Linay, Kirk Bateman, Sascha Ahrweiler, Dany Guerendo, Kim Musgrave, Nancy Brucken, Lina Jorgensen, Karolyn Kracht, Francois Vandenhende, Sheryl Treichel, Terry Walsh, Mohammad Fayaz, Mercidita Navarro, Jane Diefenbach, Christos Stylianou, Pierre Nicolas, Rebeka Ravis, Karin LaPann, Asa Carlsheimer, Peter Schaefer, Kristen Harrington, Nhi Beasley, Gustav Bernard, Mithun Ranga, Julie Shah, Jim Gaiser, John Smith, Susan Duke, Greg Ball, Lothar Tremmel, Brenda Crowe, Lisa Houterloot, Aimee Cyr, Krishan Singh, Joy Li, Barabara Witczak, Margo Cohen, Julie Shah, Shafi Chowdhury, Aiming Yang, Zhen Wang, Lei Gao, Lori VanMeter
Project Liaisons
  • Karin LaPann, Nancy Brucken - CDISC ADaM
  • Mercy Navarro - Script Repository Project Teams
  • Mary Nilsson - CFAST, Steering Committee
  • Susan Duke, Greg Ball, Lothar Tremmel - ASA Safety Monitoring Working Group
  • Rebeka Revis, Wei Wang - PhUSE Data Visualizations project team
  • Mike Carniello - ASA SSPA

Project Description

Project Name
Create white papers providing recommended display and analysis including Table, List and Figure shells
Description
This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection.

Project Goal

Create white papers outlining recommended analyses for common Tables, Figures, and Listings (TFLs) for clinical trial study reports and integrated summary documents, and to get code created in the Script Repository for the recommended TFLs.

White Papers:

  • 1. Analyses and Displays Associated with Measures of Central Tendency – With a Focus on Vitals, ECGs, and Labs in Phase 2-4 Clinical Trials and Integrated Summary Documents
  • 2. Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal – With a Focus on Vitals, ECGs, and Labs in Phase 2-4 Clinical Trials and Integrated Summary Documents
  • 3. Analyses and Displays Associated with Adverse Events – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
  • 4. Analyses and Displays Associated with Demographics, Medications, and Disposition – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
  • 5. Analyses and Displays Associated with Hepatotoxicity – With a Focus on Phase 2-4 Clinical Trials and Integrated Summary Documents
  • 6. Analyses and Displays Associated with Non-Compartmental Pharmacokinetics – with a focus on clinical trials
  • 7. Analyses and Displays Associated with QT Studies
  • 8. Analyses and Displays Associated with Questionnaire Data
  • 9. Analyses and Displays for Events of Special Interest
  • 10. Defining Treatment Emergent Adverse Events

Ideas:

  • 1. TOSNP and Narratives
  • 2. Combining Studies for Integrated Analyses - Points to Consider
  • 3. Qualitative ECGs
  • 4. Analysis of genomic and biomarkers (idea from Michael Man)
  • 5. Statistical methods for safety (individual study and integrated, include Bayesian methods)
  • 6. Writing statistical results for safety (individual study and integrated)
  • 7. Process for determining Adverse Drug Reactions
  • 8. Defining the safety population (not necessarily a separate white paper, but include somewhere)
  • 9. Analysis and display of adjudicated data
  • 10. Safety in Rare Diseases (idea from Steve Wilson)
  • 11. Clinpharm Studies
  • 12. Safety Updates

Project Plan Overview

Project Plan

Each white paper has its own wiki page providing the status and plans. Note: We're not always that good at keeping these up-to-date. Sorry!

SS P08 Central Tendency White Paper
SS P08 Outliers/Shifts White Paper
SS P08 Adverse Events White Paper
SS P08 Demographics, Disposition, Medications White Paper
SS P08 Hepatotoxicity White Paper
SS P08 PK White Paper
SS P08 QT Studies White Paper
SS P08 Questionnaire White Paper
SS P08 Events of Special Interest White Paper

Action Items

Everyone:

  • Spread the word about the white papers that have been finalized and the overall Working Group efforts any chance you get!
  • Help keep the Project 07 spreadsheets up-to-date (both upcoming forums to be on our radar, and completed presentations)
  • Please forward any displays for consideration and/or topics that should be addressed to the leads/co-leads of the white papers that are in progress
  • Please provide comments as the white papers are sent for review. Forward to anyone you think would be interested in participating in the review.


White paper leads/co-leads:

  • Keep the Phuse Wiki Project 08 pages up-to-date with information specific to your white paper.
  • Work on your white paper drafts!
  • When you're ready to have a white paper reviewed, contact Dirk Spruck. He can facilitate Steering Committee review prior to the draft being sent for public comment. He can also help with both Agilewords and the wiki. We want the draft uploaded to the Wiki and a link in 3 places - Project 8 white paper page, PhUSE home page, our Working groups News section. A link to agilewords should be included in the wiki. Both the link to agilewords and the link to the uploaded document on the wiki should be emailed to the reviewers. The reviewers include: CSS-WG-Standard-Scripts@listbox.com; CSS-WG-Standard-Scripts-WhitePapers@listbox.com and CSS-WG-SS-WhitePaperReviewers@listbox.com


Mary:

  • Facilitate white papers project team meetings
  • Help write white papers as needed
  • Work with the CPE project team
  • Maintain wiki and listboxes
  • Coordinate with other external efforts

Orientation

Documents that may be useful to be aware of during this project:

  • Clinical Review Template (supersedes Reviewer Guidance)
  • The following FDA guidance: Reviewer Guidance Conducting a Clinical Safety Review of A New Product Application and Preparing a Report on the Review
  • The following paper: Crowe BJ, Xia A, Berlin JA, Watson DJ, Shi H, Lin SL, et. al. (2009). Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team. Clinical Trials 2009; 6: 430-440.
  • ICH E3: Structure and Content of Clinical Study Reports
  • Guideline for Industry: Structure and Content of Clinical Study Reports
  • Guidance for Industry: Premarketing Risk Assessment
  • Guidance for Industry: Drug-Induced Liver Injury
  • ICH M4E: Common Technical Document for the Registration of Pharmaceuticals for Human Use - Efficacy
  • E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential For Non-Antiarrhythmic Drugs
  • Guidance for Industry: E14 Clinical Evaluation of QT/QTc. Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
  • ICH E2F: Development Safety Update Report
  • Japan Guidance Japan Guidance
  • CIOMS VI CIOMS VI

Other Efforts with Potential Overlap

  • CDISC - ADaM (Karin LaPann and Nancy Brucken are our liaisons)
  • DIA Scientific Working Group - "Safety Analysis and Reporting" is currently listed as a proposed group.
  • Cross-industry Graphics Working Group - We should coordinate any recommended figures with this group (Part of CTSpedia).
  • CFAST/TransCelerate - Working on Therapeutic Area User's Guides (TAUGs). So far, QT Studies is an overlapping topic. TransCelerate members have offered to be part of our review cycles and are on the WhitePapersReviewers listbox.
  • ASA/SSPA considering a working group that might overlap

Project Meetings

Meeting Minutes


Category Identification



Last revised by MaryNilsson,03/30/2018