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.
Dr. Barbara E. Bierer and MRCT Center Program Manager, Laura G. Meloney, co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to consider to address the problem.
MRCT Center Senior Advisors, Luke Gelinas and David Strauss, MRCT Center Faculty Director, Barbara E. Bierer, and others co-authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making.
