News & Views

26 February 2015 

SPOTLIGHT

Executive Committee In-Person Meeting Scheduled
  
The next in-person meeting of the MRCT Center's Executive Committee will be on

24 June 2015, 12:00-5:00PM, at the MRCT Center at Harvard's offices in Cambridge, Massachusetts. A detailed review of ongoing and planned programs will be discussed.

 

 

 

Promoting Clinical Trial Data Transparency Conference

The MRCT Center is hosting a 2-day, invitation-only conference in late March that will discuss high-level principles of clinical trials data sharing, with the explicit goal of developing an approach whereby data from multiple sources can be integrated, enabling researchers to access and combine data across various platforms and sponsors. Current approaches and lessons learned will be discussed, as well as common standards, criteria for review and approval and for access to data, technical solutions for aggregation, and the terms and enforcement of data use agreements.  

 

We have limited slots available for MRCT Center sponsors - please inquire if you are interested to [email protected].

Learn More. 



Capacity building in India
 
Prior to the conference in Delhi, MRCT Faculty Co-Director participated in a panel at the Bangalore India Bio Conference, Bangaluru, Bangalore, 9-11 February 2015.


In collaboration with the Indian Society for Clinical Research (ISCR), Dr Barbara Bierer (MRCT Center Faculty Co-Director) and Shoibal Mukherjee (Consultant, India) organized and taught a practical workshop entitled  "Best Practices for Determining Causality Assessment for Adverse Events Occurring During Clinical Trial Participation" in Delhi, India, on 12 February 2015. This workshop was attended by clinical investigators, regulators, industry members, and other professionals.  MRCT Center sponsors can request workshop slides for their own use at [email protected]

At the 
8th annual conference of the Indian Society for Clinical Research in Delhi, India, 13-14 February 2015, MRCT Center Faculty Co-Director Dr Barbara Bierer discussed 
"Hurdles to Achche Din for Patients of Tomorrow," and participated in a  panel on "Science and Health Technology Regulation in the Developing World."    

 

  



Comments submitted to EMA
On Data Transparency


The MRCT Center submitted comments to the European Medicines Agency (EMA) on their "Draft proposal for an addendum, on transparency, to the 'Functional specifications for the EU portal and EU database to be audited -- EMA/42176/2014.'"

 

Learn More. 

 

  



Return of Results to Study Participants Project Update
Webinar, Guidance Document, and Toolkit

On 19 February 2015, the MRCT Center, with collaborators, presented a webinar for sponsors on the practical implementation of return of aggregate research results to research participants and other stakeholders.

The webinar introduced how to utilize the best practices outlined in the
Guidance Document and Toolkit that a multi-stakeholder group, led by the MRCT Center, developed over the last year.

  



MRCT Center Job Opening

We are expanding our team by adding another Program Manager for our growing portfolio. If you know of an appropriate candidate, please refer him or her to our job opportunity.


Newsletter Editor: 

Carmen E. Aldinger, PhD, MPH

Multi-Regional Clinical Trials (MRCT) Center at Harvard University

http://mrct.globalhealth.harvard.edu/  

  

Please email [email protected] with questions and suggestions for the newsletter.