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Training Course: ICH for Statisticians - Part 5: Review of ICH E17

20 November 2019

Chrissie Fletcher

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Chrissie Fletcher

This session covers an overview of ICH E17 (General Principles for Planning and Design of Multi-Regional Clinical Trials). This Guideline provides guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). Drug development has been globalised and MRCT for regulatory submission has widely been conducted in ICH regions and beyond. Regulatory agencies are currently facing some challenges in evaluating data from MRCTs for drug approval and it was deemed necessary to developed a Harmonised international Guideline to promote conducting MRCT appropriately, especially focusing on scientific issues in planning/designing MRCTs. This Guideline complements the guidance on MRCTs provided in ICH E5(R1) Guideline and facilitates MRCT data acceptance by multiple regulatory agencies.

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Training Course: ICH for Statisticians - Part 6: Other Key Regional Statistical Documents

20 November 2019

James Matcham

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James Matcham

This session covers an overview of Other Key Regional Statistical Documents. The topics covered include development planning, meta-analysis, non-inferiority studies, baseline covariates, Data Monitoring Committees, multiplicity, adaptive designs, endpoints and payer/reimbursment.

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Training Course: ICH for Statisticians - Part 7: Question and Answer Session

20 November 2019

James Matcham, Chrissie Fletcher, Kerry Gordon

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James Matcham, Chrissie Fletcher, Kerry Gordon

Question and Answer Session from the ICH for Statisticians training course. 

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Training Course: ICH for Statisticians - Part 1: Introduction to ICH Regulatory Environment and Seeking Advice from Regulators

19 November 2019

Caroline Pothet

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Caroline Pothet

The first part of this session covers an overview of ICH guidelines and the founding members (FDA, EMA, PMDA). The second part of this session covers an overview of seeking scientific advice from regulators.

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Training Course: ICH for Statisticians - Part 2: Overview of ICH & Other Key Regional Regulatory Agency Documents

19 November 2019

Caroline Pothet

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Caroline Pothet

This session covers an overview of ICH and other key regional regulatory agency documents (FDA, EMA, CDE, PMDA), including an overview of ICH E6 (Good Clinical Practice) and ICH E8 (General Considerations for Clinical Studies).

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Training Course: ICH for Statisticians - Part 3: Review of ICH E9

19 November 2019

Chrissie Fletcher

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Chrissie Fletcher

This session covers an overview of ICH E9 (Statistical Principles for Clinical Trials) and E9 (R1) Addendum (Estimands and Sensitivity Analysis in Clinical Trials). 
ICH E9 sets out the principles of statistical methodology applied to clinical trials for marketing applications submitted in the ICH regions. The principles outlined in this guidance are primarily relevant to clinical trials conducted in the later phases of development, many of which are confirmatory trials of efficacy. An addendum was proposed to provide clarification on E9 and an update on the choice of estimand in clinical trials to describe an agreed framework for planning, conducting and interpreting sensitivity analyses of clinical trial data. The Addendum is proposed to focus on statistical principles related to estimands and sensitivity analysis, not on the use or acceptability of specific statistical procedures or methods. While a variety of mid-stage and late-stage clinical trials may be in scope, the primary focus of the Addendum will be on confirmatory clinical trials.

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Training Course: ICH for Statisticians - Part 4: Review of ICH E10

19 November 2019

James Matcham

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James Matcham

This session covers an overview of ICH E10 (Choice of Control Group). ICH E10 addresses the choice of control groups in clinical trials considering the ethical and inferential properties and limitations of different kinds of control groups. It points out the assay sensitivity problem in active control equivalence / non-inferiority trials that limits the usefulness of trial design in many circumstances.

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Training Course: Multiple Testing in Confirmatory Clinical Trials Part 1 - Introduction to Multiple Testing

09 May 2018

Lisa Hampson & Carl-Fredrik Burman

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Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. This introductory lecture looks at multiplicity issues and how they can arise for several reasons, e.g.: the possibility of winning on two different endpoints (like PFS and OS), interim analyses, or testing for effects in several patient groups. The impact of multiplicity is covered and error rates and power are defined.

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Training Course: Multiple Testing in Confirmatory Clinical Trials Part 2 - Recycling and Graphical Methods

09 May 2018

Lisa Hampson & Carl-Fredrik Burman

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Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. The second lecture in this collection reviews how to maintain strong control of the family-wise error rate, the concept of recycling (including road maps), the Holm procedure, closed testing, logic restrictions and the pooled test. 

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Training Course: Multiple Testing in Confirmatory Clinical Trials Part 3 - Utilising correlations and evaluating operating characteristics

09 May 2018

Lisa Hampson & Carl-Fredrik Burman

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Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. This third lecture covers definitions of power (1-dimensional power, multi-dimensional power, disjunctive power and conjunctive power) with examples using different Bonferroni weights. Power comparisons for Bonferroni, Holm, Dunnett and Hochberg tests are discussed. 

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Training Course: Multiple Testing in Confirmatory Clinical Trials Part 4 - Group Sequential and Adaptive Designs

09 May 2018

Lisa Hampson and Carl-Fredrik Burman

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Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. This fourth lecture covers GSDs monitoring a single endpoint, including one-sided and two-sided group sequential testing, error spending tests and calculation of repeated confidence intervals. GSDs monitoring multiple endpoints or treatments are also discussed. 

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Training Course: Multiple Testing in Confirmatory Clinical Trials Part 5 - Using Decision Analysis to Optimise Multiple Testing

09 May 2018

Lisa Hampson & Carl-Fredrik Burman

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Regulatory agencies require strong control of the Type I Error for all confirmatory statistical tests. This fifth lecture covers using decision analysis to optimise multiple testing, for example using utility functions to find the optimal weights for multiple endpoints (e.g. PFS and OS) and using time-functions for utility to decide how many interim analyses to have. 

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