Published on: March 1, 2022
Published in: Clinical Therapeutics
Description: MRCT Center Faculty Director Dr. Barbara Bierer and Program Manager Sylvia Baedorf Kassis contributed to a published report of the National Academies of Sciences, Engineering, Medicine “Health Literacy in Clinical Research: Practice and Impact – Proceedings of a Workshop.”
Published on: December 2020
Published in: European Medical Writers Association (EMWA)
Published on: April, 2023
Published in: DIA Global Forum
Description: Our collaboration with CDISC to make the MRCT Center Clinical Research Glossary available as a global standard is featured in the April edition of DIA’s Global Forum! Take a moment to read it and learn more about this wonderful development.
Published on: November, 19, 2020
Published in: PhRMA The Catalyst
Published on: October 28, 2021
Published in: American Journal of Bioethics
Published on: April 4, 2023
Published in: JAMA
Trial termination (the decision to end a trial earlier than planned) has been reported in 17.9% of cardiovascular trials and 16.0% of surgical trials.1,2 Although some trials are terminated for scientific reasons due to safety, efficacy, or futility, many trials are terminated due to inadequate participant enrollment or other nonscientific reasons.
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.
Published on: December, 2018
Published in: Journal of Clinical and Translational Science
Published on: April, 2020
Diagnostic tests for COVID-19 are central to most proposed plans for relaxing physical distancing and related policies. The following work by Deborah A. Zarin, MD MRCT Center Program Director and Joseph Lau, MD ,Professor Emeritus of Health Services, Policy and Practice, Center for Evidence Synthesis in Health, Brown University School of Public Health serves as a reminder about what we know and don’t know about these tests, how frequently they might produce inaccurate results, and how these inaccuracies might affect their utility in different potential scenarios.
