April 23, 2019

SPOTLIGHT
New Executive Committee Member: Microsoft Life Sciences Innovations
 
 
The MRCT Center is delighted to announce the addition of Microsoft Life Sciences Innovations to the MRCT Center Executive Committee.  
 
The Life Sciences Innovation Hub is focused on the digital transformation of clinical research, believing that faster and more efficient approaches to demonstrating patient safety, efficacy and value are now possible, and that the technology systems needed for the next generation of clinical research will be fundamentally different to those in use today. The mission of Microsoft's Life Sciences Innovation Hub is to provide the underlying technologies necessary to enable these changes, and to partner with industry leaders to drive it. 
 
We welcome Paul Slater, Co-Founder, Life Sciences Innovation Hub, Microsoft Corp, as our new Executive Committee member. 
 
Read more about MRCT Center Sponsors 
INTERNATIONAL COLLABORATION
Japanese Collaborators
The MRCT Center hosted Hiroshi Watanabe, Tatsuo Iiyama, and Masato Ichikawa of Japan's National Center for Global Health and Medicine Center for Clinical Sciences in March. Our collaborators have translated a suite of health literate, participant-facing research brochures, initially developed by the Harvard Catalyst, into Japanese.  Ms. Jacquelyn-My Do, representing Harvard Catalyst, joined the meeting to discuss further cooperation in international clinical trials activities.

India New Rules Released

On March 19, 2019, the Ministry of Health and Family Welfare of India released the "New Drugs and Clinical Trials Rules, 2019."[1] These rules included significant definitions, clarifications, opportunities, and expectations that, together, improved the clinical trial regulatory environment in India.

The rules constitute a significant advance for the country and encompass welcome clarifications for sponsors and investigators seeking to site clinical trials in India.




[1] New Drugs and Clinical Trials Rules, 2019,  Ministry of Health & Fam. Welfare, Notification, G.S.R. 227(E), (March 19, 2019)

Read more about the new rules in India

Read more  about our work in India
UPDATES
The MRCT Center speaks on Health Literacy at two recent workshops
 
In late March, the MRCT Center co-sponsored Plain Language for Health (PL4H) Writing and Design Workshop for Research and Practice,  a two-day workshop held at Tufts School of Medicine that focused on using plain language principles to improve research-related communications.  Sylvia Baedorf Kassis, Sr. Program Manager, participated in a panel discussing tools and techniques to support health literacy, and Sarah White, MRCT Center 
Executive Director, jaddressed health literate communication in informed consent.

In mid-April, Dr. Barbara Bierer, MRCT Center Faculty Director, gave the opening keynote at the National Academies of Science, Engineering, and Medicine Roundtable "Workshop on Health Literacy in Clinical Trials: Practice and Impact."
 
 
 
 
 
Read more on our News Page
 
Read more about our work in health literacy

UPCOMING
Launch of Proactive Safety Surveillance Initiative    
May 3, 2019 
 
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders.  Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. 

In collaboration with others, the MRCT Center is launching the Proactive Safety Surveillance initiative that aims to improve upon the current safety surveillance systems by creating a global, cooperative approach for more proactive, predictive safety surveillance system(s). 
 
As the official launch to the project, on May 3, 2019, MRCT Center has invited stakeholders from industry, government and academia, cloud providers, and patients/patient advocates to participate in an invitation-only small meeting or Visioning Session in order to identify the salient issues, the challenges, and opportunities and to further explore the need for and characteristics of such an approach. 
 
Read More about the launch here
MRCT Center Bioethics Collaborative: Impact of Mobile Devices & Wearable Technologies on the Design and Conduct of Clinical Research
May 2, 2019  
 
The widespread use of mobile smart devices and wearables has and will change how clinical research is conceptualized and conducted. Consequently, participants' data may now be leveraged for a variety of health purposes, including the development of remote screening and diagnostic tools, early intervention programs, and the promotion of public health. 
   
Attendees of the May 2nd  Bioethics Collaborative will consider the emergent ethical issues that arise in the collection and use of data obtained from mobile devices, including issues of confidentiality, privacy, comprehension, and reuse. 
 
Read More about the Bioethics Collaborative May 2nd meeting
STAFF UPDATES
New Student Researchers

Josh
Josh Smith-Sreen joined the MRCT Center this month, focusing primarily on the Center's project on the Representation of Diverse Populations in clinical research. Joshua will graduate from Boston University in May 2019 with a BA in Biology and minor in International Relations and is pursuing his Master of Public Health degree from the Boston University School of Public Health.
Read more  about Josh
 
 
Jame Jones joined the MRCT Center this month, focusing on reconceptualizing project-specific websites as well as helping to publish the monthly newsletter. In addition to working on center-wide projects, he will develop resources to promote diversity in clinical research.
 
James will graduate from Boston University School of Public Health with an MPH this spring, with concentrations in Epidemiology and Program Management.  James received his B.A. in Neuroscience from Amherst College and previously worked as a research technician at Weill Cornell Medicine in New York. 
Read more about James

Newsletter Editor: James Jones
 
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
 
Please email mrct@bwh.harvard.edu with questions and suggestions for the newsletter.