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 6-7: Understanding statistical aspects of additional regulatory (EMA, FDA, PDMA, CDE & TGA) requirements for clinical trials and what to expect in ICH E20 (Adaptive Designs, anticipated in 2021).
Target Audience: Statisticians
Presenter: James Matcham
The seminars will be delivered by James Matcham, who 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.
ACTA Trial of the Year Award 2020 guidelines and nomination forms
Bayesian adaptive randomised clinical trials flyer
ACTA STInG grant advice for trial statisticians
ACTA STInG Notes from Members’ meeting, October 2019
ACTA STInG 2017 Member Survey Results
ACTA STInG Submission to the NHMRC Structural Review
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How to plan well and be prepared for the unexpected – Data and Safety Monitoring Boards Webinar Series
Webinar: Data Safety and Monitoring Boards for Adaptive Trials
Bayesian Adaptive Randomised Clinical Trials Workshop, Sydney
Bayesian Adaptive Randomised Clinical Trials Workshop, Melbourne
Bayesian Adaptive Trials Workshops: Perth