In the Spotlight
MRCT Center releases 2021 Impact Report
The MRCT Center 2021 Impact Report has been released! This year, our report is web-based and interactive. Thank you for your continued support. Your contributions ensure that we, collectively and collaboratively, promote the ethical conduct of clinical trials across the globe.
Read the MRCT Center Impact Report
Equity by Design in Clinical Research: Cancer Trials virtual training series recap
Please save the date for the training on Equity by Design in Clinical Research: Cancer Trials! Additional information about the course and a link for registration will be forthcoming through MRCT Center and Dana-Farber/Harvard Cancer Center in early 2022.
Sign up for upcoming updates!
Time to Listen: Hearing from Young People in Clinical Research
On 2 February 2022, the MRCT Center will host the second “Advancing International Pediatric Clinical Research” conference, focusing on incorporating the perspectives of young people and the adults who care for them in clinical research and product development.
The webinar will be hosted twice, from 9-11 am EST and from 8-10 pm EST, with similar content but different speakers and panelists, to allow for wide attendance and global participation. Stay tuned for further details!
Sign up for upcoming webinar updates!
Proceedings are now available from “Reimagining Clinical Trials: Learning from COVID-19.” This two-part meeting was hosted by the MRCT Center and included panels of experts discussing varying topics. The first meeting focused on permissible flexibilities to study conduct and coordination, including site flexibilities, decentralized trials, and other changes, and the implications for the clinical research workforce in this new environment. The second meeting addressed regulatory flexibilities, international cooperativity, and governance. Read the proceedings.
Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa
We are delighted to announce that applications are open for the second AVAREF – MRCT Center Training for Ethics Review of Clinical Research, a Virtual Training Course for Africa. This course is open to all countries in Africa and is designed for members and chairs of research ethics committees, and those involved in reviewing clinical research applications. Women are encouraged to apply. Translation into French will be available.
- Applications in English are available here.
- Applications in French are available here.
Application close date is 31st January 2022.
MRCT Center Virtual Training Inspires Students and Lectures in Indonesia
In October 2021, the MRCT Center delivered seven modules as part of a 2-week clinical research virtual training to undergraduate and graduate students and lecturers participating in the Pfizer Biotech Fellowship program in Indonesia. The curriculum was designed to introduce students to the process of drug discovery and development in clinical research, as well as inspire them with guest speakers sharing their personal experience.
Read an article in The Jakarta Post about this training.
PRESENTATIONS
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- October 13, 2021: MRCT Center Executive Director Sarah White was a panelist at the National Health Council Science of Patient Engagement Symposium, “Accelerating Trust in Clinical Research: Turning Experiences into Action.”
- October 21, 2021: MRCT Center Program Manager Sylvia Baedorf Kassis discussed the importance of health literacy in clinical research with members of Latinos In Clinical Research.
- November 8, 2021: Sarah White and Sylvia Baedorf Kassis presented an AAHRPP webinar, “Health Literacy Resources to Strengthen your Human Research Protection Program.”
- November 17, 2021: MRCT Center Faculty Director Barbara Bierer presented and moderated at PRIM&R: Inclusion of Persons With Disabilities in Clinical Research.
- November 19, 2021: Dr. Bierer presented on a PRIM&R panel, “Access to Clinical Research for People With Limited English Proficiency (LEP)” at the PRIM&R’s 2021 Advancing Ethical Research (AER) Virtual Conference.
- November 29, 2021: Dr. Bierer spoke at the Research Ethics Review Streamlining Initiatives, a webinar hosted by The Canadian Collaboration for Child Health: Efficiency and Excellence in the Ethics Review of Research (CHEER).
PUBLICATIONS
Demystifying Schrems II for the cross-border transfer of clinical research data
Liss J, Peloquin D, Barnes M, Bierer BE. Journal of Law of the Biosciences, 8(2), July-December 2021. DOI:
10.1093/jlb/lsab032
Monitoring the Pediatric Clinical Trials Enterprise
Califf RM, Zarin DA. Pediatrics, 148 (3): e2021051589. September 2021. DOI: 10.1542/peds.2021-051589
Integrating Supported Decision-Making into the Clinical Research Process
Bierer BE, Ne’eman A, DeCormier Plosky W, StraussDH, Silverman BC, Stein MA. The American Journal of Bioethics, 21(11):32-35. October 2021. DOI:10.1080/15265161.2021.1980141
Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use
Seykora A, Coleman C, Rosenfeld SJ, Bierer BE, Lynch HF. Ethics & Human Research, 43(2021):1-17. October 2021.DOI:10.1002/eahr.500106
Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomized, factorial, mixed methods trial
South A, Joharatnam-Hogan N, Purvis C, James EC, Diaz-Montana C, Cragg WJ, Tweed C, Macnair A, Sydes MR, Snowdon C, Gillies K, Isaacs T, Bierer BE, Copas AJ. PLoS Medicine, 18(10):e1003798. October 2021. DOI: 10.1371/journal.pmed.1003798
Characterization of Informed Consent Forms Posted on ClinicalTrials.gov
Tse T, White S, Gelinas L, Morrell W, Bierer B, Zarin D. JAMA Network Open, November
2021. 4(11):e2135146. DOI:10.1001/jamanetworkopen.2021.35146