Publication
Published on: November, 19, 2020
Published in: PhRMA The Catalyst
Committing to diversity, equity and inclusion: A call to action for clinical trials
Resource Type: Publication
Integrating Supported Decision-Making into the Clinical Research Process
Publication
Published on: October 28, 2021
Published in: American Journal of Bioethics
Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials
Publication
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.
Leveling the Joint Task Force Core Competencies for Clinical Research Professionals
Publication
Published on: October 2018
Published by: Therapeutic Innovation & Regulatory Science
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals
Publication
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.
Returning Aggregate Results of Clinical Trials
Publication
Published on: December, 2018
Published in: Journal of Clinical and Translational Science
Diagnostic Testing for COVID-19: Considering False Positive and False Negative Results by Deborah A. Zarin, MD, MRCT Center Program Director and Joseph Lau, MD
Publication
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.
Data visualization explorer: A tool for participant representation
Publication
Published on: March 29, 2023
Published in: Patterns
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.
Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed
Publication
Published on: March 30, 2023
Published in: JAMA
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…
Dr. Barbara Bierer is Featured in the Exploring Drug Discovery and Development Article “Scientists and Communicators Team Up To Increase Clinical Trial Participation”
Publication
Published in: April 8, 2022
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.
