The MRCT Center is pleased to announce that we have received endorsement to become a Pilot Center of Excellence (CoE) at the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) SOM1 Meeting in Nha Trang, Vietnam.
The aim of this project is ultimately to become certified as an APEC Training Center of Excellence for Multi-Regional Clinical Trials (MRCTs) and Good Clinical Practice (GCP) inspection to train regulators from APEC economies.
The objectives of our Pilot Center of Excellence are: (1) to build skilled capacity in clinical trial regulatory science to facilitate review and oversight of MRCTs and GCP inspection in APEC economies and (2) to collaborate closely with others in the MRCT/GCP priority work area to determine the optimal curricula, method(s) and configuration to deliver training in a culturally-appropriate manner.
The training for regulators will be planned for spring 2018 and will be co-hosted by the APEC Harmonization Center.
Read more about APEC’s Life Sciences Innovation Forum.
On October 19, 2016, 52 participants from academia, industry, non-profit organizations, professional associations and regulatory agencies gathered at Harvard Faculty Club for a workshop on “Core Competencies in Clinical Research: Real World Applications, Convergence and Evolution of Framework.”
Fifteen case studies from five countries and results of a global survey showed that the core competencies have been utilized for innovative workforce development in the clinical research enterprise–for re-shaping academic curricula, revising job descriptions, and educating and certifying professionals in competencies for conducting clinical research. Next steps will include revisions of competencies based on feedback received, levelling/tiering of competencies for different job descriptions, and, in a later phase, developing metrics, evaluation, training and educational resources.
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.
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.
The Multi-Regional Clinical Trial Center at Harvard has an initiative focused on training of Data Safety Monitoring Board (DSMB) members; this initiative is driven by a working group comprised of stakeholders from industry and academia and the 2013 class of DSMB Fellows were equally as diverse.
The goal of the initiative is to identify, train, recruit experts from emerging regions who have expertise in medicine or statistics, experience in clinical trials, and who would like to serve on Data Safety Monitoring Boards or Committees. The mission is to increase engagement of experts from emerging world countries on DSMBs, since currently, the countries in which many clinical trials are run are not represented in these important committees.
The culmination of this work has been the selection of the first class of fellows for this training. The fellows attended the workshop training, co-sponsored by the Society of Clinical Trials. They attended two pre-meeting workshops (P3 and P9) on May 19, 2013 titled “So you’ve said “yes” Now What? Sitting on or Chairing a Data Safety Monitoring Board” and “Data Safety Monitoring Boards for Multi-Regional Clinical Trials.”
Out of 90 applications, 11 fellows were selected from Brazil, India, Korea, Mexico, South Africa, Thailand, Argentina, and Russia. The Society for Clinical Trials met next in Boston, Massachusetts, May 19-22, 2013. For information about the Society and the meeting, see www.sctweb.org.
The Society for Clinical Trials, created in 1978, is an international professional organization dedicated to the development and dissemination of knowledge about the design, conduct and analysis of government and industry-sponsored clinical trials and related health care research methodologies.
The Data & Safety Monitoring Work Group is holding an all-day training session for eleven fellows on May 19, 2013.
The eleven fellows are traveling to Boston for the training and the SCT 34th Annual Meeting. They will be coming from Brazil, South Korea, India, South Africa, Thailand, Russia and Mexico. Fellows were selected from countries that commonly host clinical trials, but which are often not represented on the trials’ Data and Safety Monitoring Boards. They were chosen based on previous experience with clinical trials and their intention to contribute to clinical trial research in the future.
On February 15, 2013, the MRCT PI Training and Competence Working Group hosted a half-day focus group collaboration meeting at the Harvard Global Health Institute with Ingrid Klingmann (IMI/Pharmatrain), Bob O’Neill (FDA), Greg Koski (ACRES), Honorio Silva (ACRES) and Jason Nyrop (Deloitte) and Rohin Rajan (Deloitte). The objectives of the meeting included:
Discuss in-flight, planned initiatives and strategic approaches in PI training and standards
Discuss how the groups might collaborate towards a single set of standards for PI competency
Lay out a roadmap in this area for our groups to avoid duplication of efforts, maximize efficiencies and promote collaboration
