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.
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.
Description: Dr. Barbara Bierer, MRCT Center Faculty Director, and Laura Meloney collaborated with Ariel Carmeli, a graduate student at Harvard Medical School Department of Biomedical Informatics and Harvard Business School, to develop a dynamic data visualization tool. The tool allows users to explore demographic representation in clinical trials associated with 339 FDA drug and biologic approvals from 2015-2021, using data from FDA Drug Trials Snapshots. The tool can help organizations improve trial representation and enhance health equity by providing information on trial representation over time, according to race, ethnicity, age, and sex, across therapeutic areas and pharmaceutical sponsors. A co-authored article about the tool, “Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products,” was published in Cell Patterns.
Description: This study examined the proportion and timing of results dissemination for registered trials by data source (i.e., ClinicalTrials.gov and PudMed) and funder type.
Timely dissemination of clinical trial results is essential for improving transparency and ensuring that findings are available to inform evidence-based medicine.1 Prior analyses of results dissemination assessed PubMed-indexed publications for National Institutes of Health (NIH)–funded trials completed by 2008; trial results published by academic and industry funders with results posted on ClinicalTrials.gov in 2012; and published or posted results of industry- and nonindustry-funded trials completed by 2015. In this study, the proportion and timing of results dissemination for registered trials were examined by data source (ie, ClinicalTrials.gov5 and PubMed) and funder type…
Published in: Exploring Drug Discovery and Development
Dr. Barbara Bierer is featured in the Exploring Drug Discovery and Development article “Scientists and communicators team up to increase clinical trial participation” a look at clinicians, researchers, and communicators developing more effective strategies to disseminate information about clinical trials to reach a wider audience.
MRCT Center colleagues Barbara E. Bierer, Laura G. Meloney, Hayat R. Ahmed, Sarah A. White authored a commentary in Cell Reports Medicine on “Advancing the inclusion of underrepresented women in clinical research.”
Published in:The Journal of Law, Medicine & Ethics
Joseph Liss, former Legal Fellow at the MRCT Center, David Peloquin, Mark Barnes and Barbara Bierer co-authored “Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate,” published in The Journal of Law, Medicine & Ethics. Title VI of the Civil Rights Act of 1964 prohibits federally-funded educational institutions and health care centers from engaging in discrimination “on the ground of race, color, or national origin.” The authors argue that the Department of Health and Human Services (HHS) “has not used the full arsenal of legal and policy tools at its disposal to push for equal rights” to obligate institutions that receive federal funding for clinical research “to provide equal access to participation in clinical trials to racial and ethnic minority communities.”
Published in: BMC Complementary Medicine and Therapies
Sylvia Baedorf Kassis, Sarah A. White, Barbara E. Bierer and others co-authored “Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial,” published in BMC Complementary Medicine and Therapies, which describes a self-monitoring toolkit that was developed and implemented in a coordinated multinational trial that involved sites in China, South Korea, and the U.S. Authors conclude that such a tool “provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities.”
Deborah Zarin, MRCT Center Program Director, co-authored “Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis,” published in BMJ. The authors describe an approach for reporting master protocol research programs that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy.
