ACTA STInG in collaboration with Cytel, invite you to come on a whirlwind tour of the current and developing statistical guidelines for clinical trials, all distilled into seven steps. This is an opportunity to be introduced, refreshed or updated on the statistical aspects of GCP in two 1 hour seminars. ICH-GCP guidelines are used in clinical trials around the globe with the main aim of protecting and preserving human rights, which is relevant for both investigator-led and industry sponsored trials. They are an international ethical and scientific quality standard; for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.
STEPS 1-5: Understanding key statistical principles in ICH E9 (Statistical Principles for Clinical Trials, R1 Estimands & sensitivity analyses), ICH E10 (Choice of Control Group in Clinical Trials), ICH E6 (Good Clinical Practice), E17 (Multi-Regional Clinical Trials).
Target Audience: Statisticians
Presenter: James Matcham

James Matcham has over 30 years’ experience as a statistician in the pharmaceutical industry. He has led the development of early clinical trial design, decisions and analysis and the development of regulatory/reimbursement approvals for biotechnology products, involving company representation at regulatory submissions in the US and EU.
James has been a member of the society for Pharmaceutical Statistics (PSI) for over 30 years, serving on the Scientific and Training Committees, as well as the Board of Directors. He has also served on the Professional Affairs Committee of the Royal Statistical Society (RSS), where he has been a Chartered Statistician for over 25 years, and is currently a member of the Scientific Committee of the European Federation of Pharmaceutical Statistics. In 2020, James moved to the Strategic Consulting group in Cytel.
Latest Resources
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ACTA STInG: N-of-1 Trials Webinar Series – Webinar 1
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ACTA 2021-2022 Annual Report
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Joint webinar on estimands in clinical trials
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Webinar: Estimands in Oncology – How and Why
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Webinar PIONEERing estimands in Clinical Research
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Estimands: Not just a statistical issue
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Resource for trial statisticians planning to apply for an academic promotion
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ACTA 2020-2021 Annual Report
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Guidance on Peer Reviewing the Statistical Aspects of a Medical Paper
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Protocols and Statistical Analysis Plans (SAPs) for Adaptive Trials
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Data and Safety Monitoring Boards Webinar Series: Statistical Principles
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Data and Safety Monitoring Boards Webinar Series: How to plan well and be prepared for the unexpected
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Statistical Analysis Plan (SAP)
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What are the benefits of adaptive designs?
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How do adaptive trial sizes work?
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What is an adaptive clinical trial?
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What is response adaptive randomisation?
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Data Safety and Monitoring Boards (DSMB) for Adaptive Trials Webinar video
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Data Safety and Monitoring Boards (DSMB) for Adaptive Trials Webinar slides
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Bayesian adaptive randomised clinical trials flyer
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ACTA STInG grant advice for trial statisticians
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ACTA STInG Notes from Members’ meeting, October 2019
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Adaptive Design Clinical Trials
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Hackathon of Novel Trial Designs part two
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Hackathon of Novel Trial Designs part one
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Studies Within A Trial SWATs webinar
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Innovative Trial Design and Conduct Reference Group Objectives and Directions
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ACTA STInG 2017 Member Survey Results
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Novel approaches to healthcare effectiveness research outside Australia
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ACTA STInG Submission to the NHMRC Structural Review
Latest Events
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ACTA STInG- Stata and R Markdown Demonstrations
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Improving clinical trial recruitment through innovative technologies
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ACTA STInG 3 part webinar series on Data Transparency (DT)
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Clinical Trials 2021: National Tribute and Award Ceremony
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Clarifying clinical trial aims and analysis using the estimands framework
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Practical approaches to Adaptive Trial Simulation
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An Introduction to Adaptive Trial Designs
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Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 2
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Statistical principles – Data and Safety Monitoring Boards Webinar Series
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How to plan well and be prepared for the unexpected – Data and Safety Monitoring Boards Webinar Series
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Webinar: Data Safety and Monitoring Boards for Adaptive Trials
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Bayesian Adaptive Randomised Clinical Trials Workshop, Sydney
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Bayesian Adaptive Randomised Clinical Trials Workshop, Melbourne
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Bayesian Adaptive Trials Workshops: Perth
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Workshop: Pragmatic randomised trial designs for evaluating health policy and practice change interventions