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14 January 2020

Richard Pugh

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The last 15 years has seen a massive shift in the role of data and analytics, driven by the increased hype around big data, data science, machine learning and AI. This presents both challenges and opportunities for analytic teams. This webinar will strip back the hype to look at what these buzzwords really mean, and talk about the impact this is having on the role, remit and operating model of analytic teams in the life sciences industry.

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10 December 2019

Pierre Colin, Juan Abellan, Gaëlle Saint-Hilary

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Pierre Colin, Juan Abellan, Gaëlle Saint-Hilary

Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies. We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level). This survey allowed us to analyze which quantitative methods are known, which quantitative methods are used (or not), what benefit is expected from this kind of methods, and what are the needs for a larger use of quantitative methods to support decision-making. It permitted to understand the gaps and some of the issues associated to the use of such methods in drug development. The webinars are intended to share the learnings from the survey and to promote different quantitative methods for decision-making.

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03 December 2019

Véronique Robert, Guido Thömmes, Oliver Sailer

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Véronique Robert, Guido Thömmes, Oliver Sailer

Quantitative methods to support decision-making in clinical drug development already exist, but may be unknown or unused by pharmaceutical companies. We performed a survey among pharmaceutical companies, targeting people with different profiles (statisticians, non-statisticians and decision-makers) working at different stages of the clinical development (study level, development level or portfolio level). This survey allowed us to analyze which quantitative methods are known, which quantitative methods are used (or not), what benefit is expected from this kind of methods, and what are the needs for a larger use of quantitative methods to support decision-making. It permitted to understand the gaps and some of the issues associated to the use of such methods in drug development. The webinars are intended to share the learnings from the survey and to promote different quantitative methods for decision-making.

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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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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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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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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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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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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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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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