Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 2

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

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.

Access the webinar recording here