We at the MRCT Center, with our friends and colleagues, mourn the passing of Padma Shri Prof Ranjit Roy Chaudhury, announced on the morning of October 27, 2015.
Prof Roy Chaudhury was a visionary, mentor and friend, instrumental to medicine, health care delivery, medical education, drug regulation, and clinical research in India. He worked tirelessly to improve the clinical research enterprise in India, knowing that only with robust clinical research programs can India hope for the rapid availability of new medicines and treatments to the people of India. He was a leader at a time when leadership was essential, an enthusiast at a time of pessimism, and a consolidator at a time of dissonance. He greeted all with a calming smile and a warm, welcoming and earnest handshake that spoke inclusion and acceptance. He was quiet but incisive.
Many of the most significant reforms in the regulatory environment in India over the last few years were outlined in recommendations that emanated from the Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs, at the direction of the Ministry of Health and Family Welfare. Those recommendations have largely been implemented, and have helped to create clinical research built on patient safety, quality and underlying scientific and ethical principles. His influence will be forever felt in the restoration of clinical research in India; the work is not finished, but his legacy is palpable. We owe it to him, and to the people of India, to ensure that new medicines and treatments, new diagnostics and therapeutics, are again available through trustworthy and robust clinical research functioning with appropriate regulatory oversight.
We have all lost a leader and friend in Prof Roy Chaudhury. We extend our heartfelt condolences to his family, to the clinical research community, and to the people of India.
Barbara E. Bierer, MD Mark Barnes, JD LLM Rebecca Li, PhD
Publication
Published on: October 21, 2015
Published in: Bloomberg BNA Medical Research Law & Policy Report
As of July 1, 2015, the MRCT Center has moved administratively to the Division of Global Health Equity, under the leadership of Dr. Paul Farmer, at the Brigham and Women’s Hospital (BWH), a Harvard teaching hospital. The Division of Global Health Equity serves as an academic and research home for more than 40 Harvard and BWH faculty who are engaged in teaching, patient care and research around the world and domestically.
The integration of the MRCT Center into the Division offers a community of colleagues and a network of thought leaders globally, as well as infrastructure for program strengthening and expansion. The mission of the MRCT Center will remain unchanged and will be strengthened through this new partnership. The MRCT Center will continue to have a collaborative relationship with Harvard, including the continued involvement of multiple Harvard faculty members and student interns.
In the process of this move, the URL of the MRCT Center’s website changed to: mrctcenter.org, and our email addresses changed to @MRCTcenter.org. Web searches and emails to previous addresses will be redirected. The general email box for the center is admin@MRCTcenter.org. Our full name is now: The MRCT Center of Harvard and Brigham and Women’s Hospital.
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.
Publication
Published on: December 1, 2014
Published in: Business Line
