Description: Luke Gelinas, MRCT Center Senior Advisor, Walker Morrell, former MRCT Center Project Manager, and Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure the privacy interests and rights of participants.
Description: Colleagues in the UK, assisted by Dr. Bierer, assessed site staff experience in returning plain language summaries to participants after completion of a trial. Not only did the staff feel that the communication was important but there were no concerns or challenges in responding to participant questions. Operations and cost were both feasible.
Description: In their article entitled “Communicating complex numeric information in clinical research,” recently published in Frontiers in Communication, Dr. Barbara Bierer and Sylvia Baedorf Kassis present an overview of the numeric concepts that arise throughout the course of research participation, as well as important considerations when presenting such information.
Description: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit.
Description: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry.
Published in: International Journal of Clinical Trials
Description: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” describing the experience of conducting a multinational acupuncture study during the pandemic.
Published in:National Center for Biotechnology Information, NIH
Description: The authors address the lack of access to the charters of data monitoring committees (DMCs) and call on the NIH to allow their voluntary upload into ClinicalTrials.gov.
DeMets DL, Zarin DA, Rockhold F, Ellenberg SS, Fleming T, Wittes J. Bringing data monitoring committee charters into the sunlight. Clin Trials. 2023 May 25:17407745231169499. doi: 10.1177/17407745231169499. Epub ahead of print. PMID: 37231737.
Description: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.
