News

September 2022 Newsletter

In the Spotlight

MRCT Center Annual Meeting: December 14, 2022

The MRCT Center Annual Meeting is scheduled for Wednesday, December 14, 2022, 8:00 AM – 1:00 PM at Ropes & Gray, Prudential Center, Boston, and is open to the public. Remote participation will be possible (but not preferred).

Please register here.


MRCT Center Pediatric Brochures for Youth

We are delighted to announce the release of three new pediatric educational brochures in the series about clinical research topics. Developed by high school and college students, written for 12- to 17-year-olds, reviewed by international youth advisory networks, and proudly bearing the the International Children’s Advisory Network (iCAN) Seal of Approval. 



WHAT IS A FOCUS GROUP & WHY SHOULD I JOIN ONE?

This brochure explains whata focus group is and what you can expect if you join one.

SENSITIVE INFORMATION IN RESEARCH

This brochure explains why researchers might ask you questions about sensitive topics and how they protect your privacy.

SHARING YOUR INFORMATION (DATA) IN RESEARCH

This brochure explains what data is and how researchers use your data in a study.

Facilitating Pediatric Medicines Development: Models of Global Cooperation

The fourth conference in the series, “Facilitating Pediatric Medicines Development: Models of Global Cooperation,” focuses on global regulatory cooperation with an eye to building on existing models to strengthen the global regulatory ecosystem for pediatric drug approval. This two-part webinar will take place on 29 November 2022 at 9 –11:30 am ET and 30 November 2022 at 9 –11 am ET. We encourage you to attend both parts of this virtual meeting as the second part builds on part one. Please register here.


Virtual DSMC Training in the Philippines

In July, the MRCT Center delivered a virtual training for members of the newly established Data Safety Monitoring Committee (DSMC) at the National Institutes of Health at the University of the Philippines in Manila, Philippines. The training described the purpose, functioning, roles, and responsibilities of a DMSC and how to review study data in an ongoing manner to make decisions for study continuation.


PRESENTATIONS

August 23, 2022: MRCT Center Faculty Director, Dr. Barbara Bierer, presented “Not net neutral: data science, technology, ethics, and social impact” at PhUSE—the Global Healthcare Data Science Community.


PUBLICATIONS

August 2, 2022: MRCT Center Program Director, Sylvia Baedorf Kassis, contributed a blog post to Amp&rsand, The PRIM&R Blog: “Integrate Health Literacy Training into Your IRB’s Onboarding and Professional Development Activities Learn More.
 
August 13, 2022: Barbara Bierer co-authored “Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials? Design and Feasibility of the Observational Patient Evidence for Regulatory Approval Science and Understanding Disease Project” published in Value in Health. This article is available, free of charge, until October 2, 2022. Learn More.
 
August 17, 2022: Sarah White, MRCT Center Executive Director contributed to the ACRP blog post related to “Tackling Diversity in Clinical Trials May Require Wider ‘Aperture’’’ Learn More.
 
August 17, 2022: MRCT Center Program Director, Dr. Deborah Zarin, and MRCT Center Postdoctoral Research Fellow, Dr. Nora Hutchinson, co-authored the article “The proportion of randomized controlled trials that inform clinical practice,” published in eLife. Learn More.
 
August 22, 2022: The MRCT Center provided public comments to the Ministry of Health and Family Welfare, New Delhi, India on their Draft of New Drugs, Medical Devices and Cosmetics BillLearn More. – This is available to MRCT Center sponsors only for the next six months. Interested in becoming an MRCT Center sponsor? Learn More.
 
And on August 2, 2022: James Miessler of WCG CenterWatch credited the Joint Task Force on Clinical Trial Competencies (JTF) in his blog Trial Professionals Need Formal Research Training to Fill Crucial Knowledge Gaps. Learn More


JOIN THE MRCT CENTER TEAM

The MRCT Center has the following job openings:

Senior Communications and Web Specialist
Program Manager, Education, and Training
Instructor or Assistant Professor Faculty position

Please forward to potential candidates!


A LOOK AHEAD

Join Willyanne DeCormier Plosky, Program Manager at the MRCT Center, and Health Affairs on Monday, October 3, 2022, at 1:00 pm ET for a free Virtual Symposium on Disability & Health. Register now
 
Also, watch for the October 3rd release of Health Affairs, in which Drs. DeCormier Plosky and Bierer from the MRCT Center and colleagues from Harvard, Mass General Brigham, University of Utah, and Columbia will publish an empirical paper on study protocol eligibility criteria that may lead to language to the inappropriate exclusion of people with disabilities from clinical trials.