Selected MRCT Center 2020 Publications
Committing to the Inclusion of Diverse Populations in Clinical Research
Ahmed HR, Strauss DH, Bierer BE. Therapeutic Innovation & Regulatory Science, January 2020. DOI 10.1007/s43441-019-00020-6
Issues in the registration of database studies
Zarin DA, Crown WH, Bierer BE. Journal of Clinical Epidemiology 121: 29-21, February 2020. DOI: 10.1016/j.jclinepi.2020.01.007
Economic vulnerability and payment for research participation
Gelinas L, White SA, Bierer BE. Clinical Trials. February 2020. DOI: 10.1177/1740774520905596
Primed to comply: Individual participant data sharing statements on ClinicalTrials.gov
Statham E, White SA, Sonwane B, Bierer BE. PLOS ONE, February 2020. DOI: 10.1371/journal.pone.0226143
Disruptive and avoidable: GDPR challenges to secondary research uses of data
Peloquin D, DiMaio M, Bierer BE, Barnes M. European Journal of Human Genetics. March 2020. DOI:10.1038/s41431-020-0596-x
Time for NIH to lead on data sharing
Sim I, Stebbins M, Bierer B, Butte AJ, Drazen J, Dzau V, Hernandez AF, Krumholz HM, Lo B, Munos B, Peraksis E, Rockhold F, Ross JS, Terry SF, Yamanoto KR, Zarin DA, Li R. Science 367 (6484), 1308-1309, 20 March 2020. DOI: 10.1126/science.aba4456
Diagnostic testing for COVID-19: Considering false positive and false negative results
Zarin DA, Lau J. April 2020.
From Genetics to Genomics: Facing the Liability Implications in Clinical Care
Marchant G, Barnes M, Evans JP, LeRoy B, Wolf SM. Journal of Law, Medicine & Ethics 48: 11-43. Spring 2020. DOI: 10.1177/1073110520916994
Aggregating data from COVID-19 trials
Ogburn EL, Bierer BE, Brookmeyer R, Choirat C, Dean NE, Gruttola VD, Ellenberg SS, Halloran ME, Hanley DF, Lee JK, Wang R, Scharfstein DO. Science 368(6496), 12 June 2020. DOI: 10.1126/science.abc8993
Health Literacy in Clinical Research: Practice and Impact – Proceedings of a Workshop
Wojtowicz A, French MG (Rapporteurs); Assaf AR, Bierer BE, Davis TC, McCormack L, Myers L, O’Leary C, Nassi PJP, Spears P, Wilkins CH (Planning Committee) Citro C, Baedorf Kassis S (Reviewers). National Academies Press, Washington, DC.
Challenges of “Return to Work” in an Ongoing Pandemic
Barnes M, Sax PE. NEJM, June 2020. DOI: 10.1056/NEJMsr2019953
Rethinking ethical oversight in the era of the learning health system
Asch DA, Joffe S, Bierer BE, Greene SM, Lieu TA, Platt JE, Whicher D, Ahmed M, Platt R. Healthcare 8 (2020) 100462. August 2020. DOI: 10.1016/j.hjdsi.2020.100462
The Decision to Enroll in a Clinical Trial Should Be Unencumbered
Gelinas L, Bierer BE. The American Journal of Bioethics, 20:9, 23-25. August 2020. DOI: 10.1080/15265161.2020.1795547
How to fix the GDPR’s frustration of global biomedical research
Bovenberg J, Peloquin D, Bierer B, Barnes M, Knoppers BM. Science 02, 370(6512), 40-42. October 2020. DOI: 10.1126/science.abd2499
Ethical Challenges in Clinical Research during the COVID-19 Pandemic
Bierer BE, White SA, Barnes JM, Gelinas L. J. Bioethical Inquiry, November 2020. DOI: 10.1007/s11673-020-10045-4
Ethical and Practical Concerns about IRB Restrictions on the Use of Research Data
Barnes M, Carrithers J, Sugarman J. Ethics & Human Research 42(29): 29-34. Nov.-Dec. 2020. DOI: 10.1002/eahr.500072
Selected MRCT Center 2020 Presentations
Legal Aspects of the Public Health Response, and What Employers Should Be Doing Now
MRCT Center Faculty Co-Director and Partner, Ropes & Gray LLP hosted a teleconference on how, as a matter of law and regulation, federal, state and local authorities address public health emergencies like the spread of coronavirus, and how the various public health authorities work together to make public health policy in an epidemic.
Drug Researchers Refuse to Follow the Law. The Government isn’t stopping them.
MRCT Center Program Director Deborah A. Zarin was a guest on NPR’s Science Friday discussing recent investigations on ClinicalTrials.gov reporting practices.
Integrating Health Literacy into Clinical Research (podcast)
Listen to MRCT Center Program Manager Sylvia Baedorf Kassis MPH, CYT talk with Helen Osborne, M.Ed., OTR/L on her Health Literacy Out Loud (HLOL) podcast about overcoming health literacy challenges when communicating with the public about clinical research studies.
Replication of Randomized Controlled Trials Using Real World Data: What Does Good Look Like?
At DIA 2020 Virtual Global Meeting, Barbara Bierer was part of a forum that explored issues in the use of real world evidence for regulatory purposes, focusing on attempts to replicate results from randomized controlled trials (RCTs) with analyses of real world data (RWD). It will describe two ongoing RCT replication efforts: the RCT DUPLICATE project and the OPERAND project.
Communicate and Co-Create with Patients Across the Medicines Development Lifecycle: Principles and Best Practices
At DIA 2020 Virtual Global Meeting, Sylvia Baedorf Kassis spoke about best practices for ethical and effective patient communication across the medicines development lifecycle, focusing on health literacy in clinical trials and plain language summaries (PLS) of publications.
Including the Patient Voice to Advance Diversity and Support Clear Communications
At BIO Digital, Barbara Bierer discussed engagement strategies and health literacy best practices in the development of clear participant-facing communications that facilitate understanding, support autonomy, and overall, inclusion and access to under-represented populations.
FDA Office of Minority Health and Health Equity webinar
This webinar, hosted by the FDA Office of Minority Health and Health Equity introduces the MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research guidance document and supplemental toolkit.
Ropes & Gray webinar: Achieving Diversity, Inclusion, and Equity in Clinical Research
“Achieving Diversity, Inclusion, & Equity in Clinical Research” webinar moderated by MRCT Faculty Co-Director Mark Barnes and Ropes & Gray Partner with speakers Dr. Barbara Bierer, MRCT Center Faculty Director, Dr. Eldrin Lewis, Professor of Medicine at Stanford University and Dr. Paul Underwood, Medical Director at Boston Scientific.
MRCT Center “Leaning In” webinar series
A series of webinars, hosted by the MRCT Center, focusing on practical approaches for improving diversity in clinical trials. Each webinar highlights a topic covered in our “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Toolkit.
Prim&R Webinar: The IRB’s Role in Achieving Diversity in Research
MRCT Center Faculty Director, Dr. Barbara Bierer, MRCT Center Executive Director, Sarah A. White, MPH and MRCT Center Senior Advisor David Strauss, MD discussing “The IRB’s Role in Achieving Diversity in Research” at the PRIM&R webinar “The IRB’s Role in Achieving Diversity in Research.”
Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations
A virtual conference hosted by the MRCT Center in collaboration with the FDA Office of Minority Health and Health Equity.