WG5 Project 08

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Project Team

Project Lead
Mary Nilsson
Project Members


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 approximately six 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.

Group 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 PhUSE wiki for the recommended TFLs.

White Papers:

  • 1. Recommended Tables, Figures, and Listings Associated with Measures of Central Tendency – With a Focus on Vitals, ECGs, and Labs in Phase 2-4 Clinical Trials and Integrated Submission Documents [Mary Nilsson]
  • 2. Recommended Tables, Figures, and Listings 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 Submission Documents [Mary Nilsson]
  • 3. Recommended Tables, Figures, and Listings Associated with Adverse Events and Deaths – With a Focus on Phase 2-4 Clinical Trials and Integrated Submission Documents [TBD]
  • 4. Recommended Tables, Figures, and Listings Associated with Demographics, Concomitant Medications, and Disposition – With a Focus on Phase 2-4 Clinical Trials and Integrated Submission Documents [TBD]
  • 5. Recommended Tables, Figures, and Listings Associated with Hepatotoxicity – With a Focus on Phase 2-4 Clinical Trials and Integrated Submission Documents [TBD]
  • 6. Recommended Tables, Figures and Listings Associated to Pharmacokinetics – with a focus on clinical trials [Francois Vandenhende]

Project Plan

The following plan proposes that we work on White Paper 1 first (to work through the process in addition to the content), then work on White Papers 2-6 in parallel.

  • White Paper 1:

Mary created first draft for review June 12th, 2012
Some team members provided comments by the July 13th target date
Mary created second draft for review October 29th, 2012
Provide comments by December 14th, 2012
Target to finalize this white paper - end of January
November – Begin discussions on how to get code for the recommended TFLs in the PhUSE Wiki
Goal – Have code for some of the recommended TFLs by March

  • White Paper 2:

Mary create first draft by end of December
Address discussion topics in March (timed with FDA/PHUSE meeting)
Mary “finalize” white paper by Q3 2013
Goal - Have code by end of 2013

  • White Paper 3:

Need leader

  • White Paper 4:

Need leader

  • White Paper 5:

Need leader

  • White Paper 6:

Francois is leading

Orientation

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

  • 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

Other Efforts with Potential Overlap

  • CDISC - ADaM (We do have team members who can monitor this)
  • DIa Scientific Working Group - "Safety Analysis and Reporting" is currently listed as a proposed group. Mary is looking into getting more information.
  • Cross-industry Graphics Working Group - We should coordinate any recommended figures with this group

Category Identification



Last revised by Kevin Kane,02/6/2013