ICH E8(R1) Introductory Overview Video

Training

Published on: October 29, 2024

Developed by: MRCT Center, in collaboration with ICH, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

The MRCT Center is pleased to announce the availability of an introductory video for the ICH E8(R1) Guideline – General Considerations for Clinical Studies. Posted on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website, the MRCT Center developed this introductory video to provide an overview of the general principles in clinical research and quality by design.

The MRCT Center is currently developing a series of in-depth training modules to complement the video.

Ethics and Review of Interventional Clinical Research: Part 1

Training

Published on: October 22, 2024

Developed by: MRCT Center, in collaboration with the World Health Organization

Description: This course was developed in partnership with the World Health Organization and aims to meet the growing demand for a training on the scientific and ethical aspects of interventional clinical trials. This course is tailored to research ethics committee members, chairs, administrative staff, and others who review clinical trial protocols. It will also benefit regulators, investigators, study staff, care providers, and others involved in clinical trials. This course is available free of charge worldwide.

Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials

Publication

Published on: June 24, 2024

Published inCancer

Description: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors on a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.