Focus Area: Capacity Building

Register for October 19, 2016 Workshop: Core Competencies in Clinical Research

The MRCT Center will host a workshop to discuss the evolution of a harmonized framework of core competencies for clinical research professionals and its application to real world experiences. Fifteen real life case studies applying the core competencies by industry, professional societies and academia in the US and global settings will be presented.

This will be an opportunity to learn more about the application of the core competencies for those seeking to apply the competencies in their own environment. Also the workshop will provide an opportunity for participants to provide feedback and discuss potential future revisions for the competency framework. Potential future projects for the work group will also be discussed.

MRCT Center holds Regulatory and Scientific Workshop at Peking University

News_11-3-15

The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.

The MRCT Center and Peking University collaborated to develop a framework, harmonized to guidance from ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), regarding how countries can consider the importance of ethnic factors, trend consistency and the definition of region in the evaluation on drug efficacy and safety for the design of multi-regional clinical trials.

A workshop at Peking University on 26 October 2015 convened 50 academic leaders, regulatory officials including CFDA, the PMDA, US FDA, and academic and industry leaders in a small, invitation-only closed meeting. Phase one of our project team efforts was presented to the global regulators, focusing on the scientific principals underlying global regulatory decision-making for multi-regional clinical trials.

Key presentations included:

  • Bob O’Neill (US FDA) History and rationale for ICH E-5 – Dr. O’Neill set the stage for how bridging may be achieved from extrapolation to utilization of data from one region to another.
  • Leigh Verbois (Director US FDA China Office) – Dr. Verbois discussed how strong regulatory systems may be effectively driven through collaboration and key learning opportunities such as this workshop. She praised the Center of Excellence concept that is being launched in Asia for training of regulators as one that will effectively build capacity in the region.
  • Workgroup 1 (Chen Gang, Johnson & Johnson; Tony Guo, Merck; Barbara Bierer, Rebecca Li, MRCT Center) – Proposed a new model for how consistency may be defined. This model contemplates 3 levels of consistency based on disease category.
  • Workgroup 2 (Luyuan Dai, Boehringer Ingelheim; Yangfeng Wu, Peking University; Pei Hu, Peking Union Medical College Hospital) – Discussed guidelines (or an algorithm) on how external and internal factors in different regions may be utilized to weigh outcomes for drug efficacy and/or safety.
  • Region workgroup (Laurie Letvak, Novartis) presented a new vision for region predicated on defining region as a subpopulation.

A full set of slide presentations is available for MRCT sponsors by clicking here. Slides from Consistency Workgroup 1 are available in Chinese here.

2015-10-26-Combined-Slides-from-Beijing-WorkshopDownload
2015-08-11-China-CFDA-comments-on-resolving-the-backlog-Chinese-TranslationDownload

The MRCT Center mourns the passing of Prof Ranjit Roy Chaudhury

News_10-27-15

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

MRCT Center Transitioned to the Division of Global Health Equity

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.