Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 1

Topics:STInG

Presentation slides

By James Matcham

Resource Documents

Seven steps for statistical success in clinical trials [Good clinical practice guidelines] Part 1 Presentation Slides

Type of resource: pdf

James Matcham

ACTA STInG in collaboration with Cytel presented a webinar which provided attendees with 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

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