News & Views

12 June 2015 
SPOTLIGHT 

       

Meet us at DIA in Washington, DC, on 17 June 

 

Two sessions at the Drug Information Association (DIA) 2015 Annual Meeting in Washington, DC, on 17 June 2015, focus disseminating the MRCT Guidance Document and Toolkit for returning results to research participants:   

 

  • 8:00-9:30am: The co-chair of the MRCT Return of Results Working Group, Laurie Myers (Merck) will present "Returning Results to Study Participants: Health Literacy and Effective Language"
  •  
  • 10:30-12:00pm: The co-chair of the MRCT Return of Results Working Group, Deborah Collyar (Patient Advocates in Research) will participate in a panel that focuses on US and EU clinical trial disclosure requirements, including results reporting and how this increase in data transparency is being perceived and used by the patient community

  


Stakeholder Meetings in China to address Regulatory Issues


   

Mark Barnes, Faculty Co-Director of the Multi-Regional Clinical Trials (MRCT) Center, and Rebecca Li, Executive Director, have just completed a two-week trip to Shanghai and Beijing to attend the Drug Information Association (DIA) conference in Shanghai. They also met with
representatives from the Pharmaceuticals and Medical Devices Agency (PMDA), China Food and Drug Administration (FDA), and our collaborators in Peking University. 

In addition, the MRCT Center hosted an in-person roundtable in Shanghai for 15 MRCT executive and steering committee members to discuss China regulatory issues.
The roundtable brought together senior regulatory affairs leaders, statisticians and counsel from multinational pharmaceutical companies to discuss: scientific perspectives on the interpretation of China's guidance on international multi-country clinical trials (IMCT), how ICH-E-5 and ICH-E17 considerations fit into the regulatory framework relating to multi-regional clinical trials, and other scientific issues.

On 18 June 2015, we will launch the MRCT workgroup on Consistency and Region which will develop methods for analyzing consistency of regional sub-groups and overall study data
(trend analysis) for key safety and efficacy outcomes. If you are interested in joining this workgroup, please contact [email protected]
 

  

Learn More about MRCT's China Regulatory Program.    

 

  



Disseminating Returning Results to Study Participants  

 

In late May, the MRCT Center participated in two conferences to present its work in returning aggregate study results to participants of clinical trials.

 

At the annual conference of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), Dr. Barbara Bierer, Faculty Co-Director of MRCT Center at Harvard, was invited to present the results of the MRCT working group on return of results to research participants.  Her talk was entitled "Sharing Clinical Trial Data With Research Participants: Regulatory, Operational, and Ethical Considerations."  

 

At the European Forum for Good Clinical Practice in Brussels, Belgium, the co-chair of the MRCT Center's Return of Results working group, Laurie Myers (Merck) spoke on, "The MRCT Center at Harvard - Toolkit and Guidance for Implementation of Returning Results to Study Participants."

 

  


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.