The MRCT Center launched a new working group on June 18, 2015, as part of the MRCT Center’s partnership with Peking University.
The key objectives for the MRCT Working Group on Consistency and Region are:
Develop methods for analyzing the consistency of regional sub-groups and the overall study data (trend analysis) for key safety and efficacy outcomes
Review prior work already done to define region and agree upon a working definition for China
Fourteen individuals from academia and industry attended the initial meeting.
This work on multi-regional clinical trial issues of trend consistency, defining region and encouraging harmonization such that a single multi-regional clinical trial conducted would be acceptable for registration by all regulatory agencies is initially applicable to China. Furthermore, we see this as highly impactful work globally that will help China and other countries harmonize the “General principle on planning/designing Multi-Regional Clinical Trials” of the International Conference on Harmonization of Pharmaceuticals for Human Use (ICH E17).
If you are interested in joining this working group, please contact MRCT@BWH.HARVARD.EDU, with the subject line: Interest in joining Consistency and Region Working Group.
The MRCT Center at Harvard continues its active engagement in India. Most recently, important efforts to address regulatory issues have been expanded to develop tools and capacity in causality assessment of adverse events that occur during participation in clinical trials.
In February 2015, MRCT Center Faculty Co-Director Dr. Barbara Bierer represented the MRCT Center at the Bangalore India Bio Conference in Bangaluru (formerly Bangalore, the capital of the Indian state of Karnataka) participating in a dynamic discussion of “Addressing Clinical Trials Complexities in India.” The conference brought together over 400 registrants, including investigators, industry representatives, regulators, and students primarily from India and other Southeast Asian countries.
Dr Barbara Bierer and Shoibal Mukherjee also taught at a one-day workshop in Delhi, India, on 12 February 2015, sponsored by the MRCT Center at Harvard in collaboration with the Indian Society of Clinical Research (ISCR). The workshop focused on “Best Practices for Determining Causality Assessment for Adverse Events Occurring During Clinical Trial Participation.” The event was attended by over 25 clinical investigators, regulators, ethics committee members, clinical research professionals, industry members, and other professionals. This was the second one-day workshop addressing causality assessment in clinical trials that MRCT at Harvard has conducted in India.
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.”
MRCT Center at Harvard Executive Director Rebecca Li co-hosted a Data Safety and Monitoring Board (DSMB) Training Workshop in Bangkok in conjunction with the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) Thai Red Cross Conference on 13 January 2015.
The learning objectives included regulatory issues pertaining to DSMBs in Thailand; understanding how trials can be monitored by DSMBs and the responsibilities of DSMB members. 62 participants from Cambodia, India, Indonesia, Japan, Malaysia, Myanmar, Pakistan, Philippines, Singapore and Thailand were in attendance. The trainees were investigators and biostatisticians from academia, government and clinical research organizations.
