Focus Area: Capacity Building

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 in: Cancer

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.

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Response to E6(R3) Guideline for Good Clinical Practice; International Council for Harmonization; Draft for Guideline for Industry

Public Comments

Comments provided on: September 5, 2023

Comments provided to: US Food & Drug Administration

The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety and well-being of all trial participants.

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