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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