News Type: Newsletter

March 2022 Newsletter

In the Spotlight

Remembering Dr. Paul Farmer

Dr. Paul Farmer was the Kolokotrones University Professor, head of the Department of Global Health and Social Medicine in the Blavatnik Institute at Harvard Medical School, chief of the Division of Global Health Equity at Brigham and Women’s Hospital, and co-founder and chief strategist of Partners In Health. Dr. Farmer passed away suddenly on February 21, 2022, in Rwanda.

Paul was a public health luminary, true humanitarian, and brilliant scholar. He made a lasting impact on social justice in global health. Paul was a dear friend of the MRCT Center and we will strive to honor his legacy in our work.

Equity by Design in Clinical Research: Cancer Trials virtual training series recap

The MRCT Center hosted, in partnership with the Center for Cancer Equity and Engagement, Dana-Farber/Harvard Cancer Center, a six-part training series entitled “Equity by Design in Clinical Research: Cancer Trials.” Each module consisted of a 45-minute video lecture and 45 minutes of an interactive discussion session with experts in the field. Over 450 people were registered. All course registrants have until May 13 to finish viewing recordings and to complete their evaluation forms for credit. After May 13, all course materials will be made publicly available on the MRCT Center website (not for CME credit). More

Return of Individual Research Results (IRR) Website Launch webinar

This one-hour webinar will be moderated by MRCT Center Project Manager Lisa Murray and include a review of IRR and its importance, patient advocate Jamie Tyrone describing her own lived experience with IRR, and a live demonstration of the new tools and website.

The webinar will be hosted on March 24th from 1 pm-2 pm ET. Register now!

Learn more about our work on returning individual research results. 

The second session of the MRCT Center Advancing International Pediatric Clinical Research webinar series: Informing the Future from COVID-19 Lessons Learned was held on February 2, 2022.

Webinar recordings and slides are now available. Subscribe for updates of future webinars in this series. MORE

Learn more about the MRCT Center Promoting Global Clinical Research in Children project.


This video, produced by Dr. Gianna “Gigi” McMillan in collaboration with the MRCT Center, features 3 young people from 3 continents, offering their thoughts on what researchers who work with young people should know.
This video, produced by International Children’s Advisory Network (iCAN) in collaboration with the MRCT Center, showcases young people from around the globe who have been involved in medical care and clinical research sharing some thoughts on what is important about including and listening to young people in clinical research.

MRCT Center welcomes a new sponsor!

The MRCT Center welcomes Mayo Clinic as a new Executive Committee member. Mayo Clinic is a nonprofit organization committed to clinical practice, education, and research, providing expert, whole-person care to everyone who needs healing. The MRCT Center is partnering with the Center for Clinical and Translational Science (CCATS), which is a central hub for institutional advancement of research and education at Mayo Clinic. The center provides tools and expert consultation to support every aspect of medical research.
 
Learn more about Mayo Clinic – Center for Clinical and Translational Science
Learn more about MRCT Center sponsors
Learn more about becoming an MRCT Center sponsor

PRESENTATIONS

On Thursday March 3, 2022 from 5:30pm-7:30pm EST: MRCT Center Program Manager Willyanne DeCormier Plosky, DrPH will be presenting on “Inclusion of People with Disabilities in Clinical Trials” at the 4th Annual Clinical Research Nurse meeting being hosted by the MGH Clinical Research Nurse Collaborative, the MGH Munn Center for Nursing Research and the Boston-New England Chapter of IACRN. The program for the meeting will focus on educating a community of CRNs on the importance of diversity, equity, and inclusion in clinical research, with a focus on clinical research nursing. Register now

PUBLICATIONS

JANUARY 31, 2022: MRCT Center Faculty Director, Barbara Bierer, with Executive Director, Sarah White, and Program Manager, Sylvia Baedorf Kassis authored a manuscript “Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community” in the Journal of Clinical and Translational Science. Read now

FEBRUARY 4, 2022: MRCT Center Program Manager, Sylvia Baedorf Kassis wrote about “How To Use Plain Language in Clinical Research Communications” in the Institute for Healthcare Advancement (IHA) blog. Read now

FEBRUARY 22, 2022: The MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy.” The MRCT Center appreciates the NIH’s efforts to update its policy to maintain currency with evolving technology and understanding. Detailed comments and suggestions can be found here. Read more

January 2022 Newsletter

In the Spotlight

ADVANCING INTERNATIONAL PEDIATRIC CLINICAL RESEARCH Webinar

Time to Listen: Hearing from Young People in Clinical Research

The MRCT Center is delighted to announce the second of the 5-part virtual conference series to advance the design, review, oversight, and conduct of global pediatric clinical trials. Ensuring all children have access to safe and effective medicines is contingent upon the conduct of trials that include them.

The second conference in the series is entitled, “Time to Listen: Hearing from Young People in Clinical Research.” This two-hour webinar will focus 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 ET and 8-10 pm ET, with similar content but different speakers and panelists, to allow for wide attendance and global participation. REGISTER NOW!

Equity by Design in Clinical Research: Cancer Trials virtual training series recap

The MRCT Center hosted, in partnership with the Center for Cancer Equity and Engagement, Dana-Farber/Harvard Cancer Center, a six-part training series entitled “Equity by Design in Clinical Research: Cancer Trials.” Each module consisted of a 45-minute video lecture and 45 minutes of an interactive discussion session with experts in the field. Over 450 people were registered. All course registrants have until May 13 to finish viewing recordings and to complete their evaluation forms for credit. After May 13, all course materials will be made publicly available on the MRCT Center website (not for CME credit). More

Training for Ethics Review of Clinical Research: A Virtual Training Course for Africa

A reminder 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 will launch in March 2022 and is open to all countries in Africa. The course 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. 

Please distribute widely. Application closing date is 31st January 2022.

PUBLICATIONS

December 15, 2021: As part of a collaborative effort, MRCT Center Faculty Director Barbara Bierer and Senior Advisor Luke Gelinas address the ethics of and approaches to allocation of participants to concurrent and competing trials to optimize studies that are adequately powered and informative in the Hasting Center Report article “Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies.” Read now
 
January 5, 2022: Recently published in Therapeutic Innovation & Regulatory Science, the Joint Task Force for Clinical Trial Competency (JTF) defined and documented core competencies related to clinical project management and project management skills. Two new specific competencies with related examples were incorporated in Version 3.1 of the JTF Framework and the wording of several existing competencies was modified. Read now


January 18, 2022: January 2022 Association of American Cancer Institutes (AACI) commentary entitled “Promoting Equity by Design in Clinical Trials”, written by MRCT Center Faculty Director Dr. Barbara Bierer and Dr. Timothy Rebbeck, Associate Director, Diversity, Equity and Engagement at Dana-Farber/Harvard Cancer Center. Read now

Welcome Kristin Bartlett to the MRCT Center!

Kristin Bartlett joined the MRCT Center as a Program Coordinator in January 2022 after 6 years at Harvard Medical School, where she served as an Executive Coordinator in the Clinical Translational Science Center. She is responsible for management and administration of ongoing projects within the Center as well as in-person and online training courses intended for a global audience. Kristin’s role serves across different programs/projects within the Center.

A LOOK AHEAD

February 3, 2022: MRCT Center Bioethics Collaborative (by invitation only) – Topic: Ethical Complexities with Human Challenge Trials
 
March 10, 2022: Meeting of the Research, Development and Regulatory Roundtable (R3) (by invitation only) – Topic: “Investigator” Designation and “Engagement” Status in Remote Clinical Research

December 2021 Newsletter

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. 

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