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.
Released in: April 2024
Developed by: Joint Task Force for Clinical Trial Competency (JTF), National Center for Health Research (NCHR) Ministry of Health and Prevention United Arab Emirates, Phoenix Clinical Research, Lebanese American University, and Sanofi.
Released in: October 2023
Developed by: Joint Task Force for Clinical Trial Competency (JTF), Comprehensive and Integrative Medicine Institute (CIMI), Medical Statistics and Informatics, Daegu Catholic University Medical Center (MSI, DCUMC)
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.
Released on: May 2022
Developed by: MRCT Center in collaboration with Dana-Farber/Harvard Cancer Center
Released on: June 2022
Developed by: MRCT Center Health Literacy Team
Published on: October 2018
Published by: Therapeutic Innovation & Regulatory Science
Published on: January 5, 2022
Published in: Therapeutic Innovation & Regulatory Science
In 2014, the Joint Task Force for Clinical Trial Competency (JTF) published its Core Competency Framework. The Framework has been utilized internationally by academic institutions, corporate entities, professional associations, educational and training programs, and regulatory agencies and integrated into their activities. The JTF has continually updated and expanded the scope of the Framework to reflect changes in the scientific understanding and methodology utilized in conducting clinical research. In 2019, representatives from the Drug Information Association Professional Development and Project Management Leadership Communities approached the JTF reflecting the importance of clinical project managers and the project management skill set to the clinical research enterprise. In response, the JTF created a Project Management Competency Task Force to define and document these core competencies with recommendations for their inclusion as a revision to the Framework 3.0. Two new specific competencies with related examples were incorporated into Revision 3.1 and expressed at the Basic, Skilled and Advanced levels. In addition, the wording of several existing competencies was modified, and related examples added to reflect the knowledge, skills, and attitudes of clinical project managers.
Released in: April 2023
Developed by: Joint Task Force for Clinical Trial Competency / Istituto di Ricerche Farmacologiche Mario Negri / Istituto Superiore di Sanita (ISS) / IFO – Regina Elena and San Gallicano Research Institutes / Ente Ospedaliero Cantonale (EOC) / Clinical Research Initiative for Global Health (CRIGH)
