Barbara E Bierer

Barbara Emily Bierer, MD

Professor of Medicine (Pediatrics), HMS
Member, HMS Center for Bioethics

Barbara Bierer, MD is a Professor of Medicine (Pediatrics) at Harvard Medical School (HMS), and a hematologist/oncologist at the Brigham and Women's Hospital (BWH). She received her MD from HMS. She is the director of the Regulatory Foundations, Law and Ethics Program of the Harvard Catalyst, the Harvard Clinical and Translational Science Award, and the director of regulatory policy, SMART IRB. Dr. Bierer co-founded and now leads the Multi-Regional Clinical Trials Center of BWH and Harvard (MRCT Center), a University-wide and collaborative effort to improve the ethics, conduct, and regulatory environment for multi-site, multi-national clinical trials. She is a co-founder of COVID-19 Collaboration Platform, a platform for cooperation in research. In 2017, the MRCT Center launched the non-profit Vivli, a global clinical research data sharing platform. From 2003-2014, she served as Senior Vice President, Research, at BWH and was the institutional official for human subjects and animal research, for biosafety and for research integrity at the BWH. She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus for entrepreneurship and innovation. Dr. Bierer established and directed the Center for Faculty Development and Diversity at the BWH; for these efforts, she was the first recipient of the HMS Harold Amos Faculty Diversity Award.

Publications View
Implementing expanded COVID-19 testing in Massachusetts community health centers through community partnerships: Protocol for an interrupted time series and stepped wedge study design.
Authors: Authors: Kruse GR, Pelton-Cairns L, Taveras EM, Dargon-Hart S, Gundersen DA, Lee RM, Bierer BE, Lawlor E, LaRocque RC, Marcus JL, Davies ME, Emmons KM.
Contemp Clin Trials
View full abstract on Pubmed
Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training.
Authors: Authors: Sonstein SA, Samuels E, Aldinger C, White SA, Bierer BE.
Ther Innov Regul Sci
View full abstract on Pubmed
Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial.
Authors: Authors: Baedorf Kassis S, Lu W, White SA, Shin IH, Park SH, Jeong YJ, Yao C, Ligibel J, Bierer BE.
BMC Complement Med Ther
View full abstract on Pubmed
Strategies to optimize inclusion of women in multi-national clinical trials.
Authors: Authors: Bierer BE, Meloney LG.
Contemp Clin Trials
View full abstract on Pubmed
When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research.
Authors: Authors: Shachar C, Gerke S, Morrell W, Kirby A, Cohen IG, Bierer BE.
Ethics Hum Res
View full abstract on Pubmed
Advancing the inclusion of underrepresented women in clinical research.
Authors: Authors: Bierer BE, Meloney LG, Ahmed HR, White SA.
Cell Rep Med
View full abstract on Pubmed
Incorporating Competencies Related to Project Management into the Joint Taskforce Core Competency Framework for Clinical Research Professionals.
Authors: Authors: Sonstein SA, Kim LP, Ichhpurani N, Padbidri R, White SA, Aldinger CE, Bierer BE.
Ther Innov Regul Sci
View full abstract on Pubmed
Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community.
Authors: Authors: Baedorf Kassis S, White SA, Bierer BE.
J Clin Transl Sci
View full abstract on Pubmed
Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis.
Authors: Authors: Di Stefano L, Ogburn EL, Ram M, Scharfstein DO, Li T, Khanal P, Baksh SN, McBee N, Gruber J, Gildea MR, Clark MR, Goldenberg NA, Bennani Y, Brown SM, Buckel WR, Clement ME, Mulligan MJ, O'Halloran JA, Rauseo AM, Self WH, Semler MW, Seto T, Stout JE, Ulrich RJ, Victory J, Bierer BE, Hanley DF, Freilich D.
PLoS One
View full abstract on Pubmed
Applying Civil Rights Law to Clinical Research: Title VI's Equal Access Mandate.
Authors: Authors: Liss J, Peloquin D, Barnes M, Bierer BE.
J Law Med Ethics
View full abstract on Pubmed