In July 2022, the MRCT Center delivered a virtual training for members of the newly established Data Safety Monitoring Committee (DSMC) at the National Institutes of Health at the University of the Philippines in Manila, Philippines. The training described the purpose, functioning, roles and responsibilities of a DMSC and how to review study data in an ongoing manner to make decisions for study continuation.
News Type: Training
The MRCT Center concludes AVAREF virtual training course
The MRCT Center – AVAREF virtual training course for Ethics Review of Clinical Research concluded in April 2022. The course included participants from 22 different countries across Africa and was simultaneously translated into French.
Case-based learnings and breakout room discussions were integrated into course lectures to create a stimulating and engaging virtual learning environment. The MRCT Center looks forward to continuing its partnership with the African Vaccine Regulatory Forum (AVAREF) to build regulatory capacity across Africa.
MRCT Center virtual training inspires students and lecturers in Indonesia
In October 2021, the MRCT Center delivered seven modules as part of a 2-week clinical research virtual training to undergraduate and graduate students and lecturers participating in the Pfizer Biotech Fellowship program in Indonesia.
The curriculum was designed to introduce students to the process of drug discovery and development in clinical research, as well as inspire them with guest speakers sharing their personal experience.
Students who participated in the training were a part of 10 teams whose ideas have been selected for the development of health biotechnology ecosystem and policy environment. Participants will revise their concept papers based on what they learned during the training, and eventually three finalists will be chosen whose ideas propose solutions to some of the hottest issues in the biotechnology industry today.
Read an article in The Jakarta Post about this training.
MRCT Center conducts training with AVAREF
In partnership with the African Vaccine Regulatory Forum (AVAREF), the MRCT Center completed the first comprehensive training of ethics committee chairs and members selected from across Africa. Conducted as an intensive virtual training, 35 matriculants, representing 18 countries, completed the training. This commitment, and the AVAREF-MRCT Center partnership, represents the importance of the ethical conduct of clinical research, of harmonizing the process of review, and of increasing efficiency and oversight while protecting the individual.
MRCT Center Delivers Virtual Training in Algeria
In May and early June 2021, the MRCT Center delivered nine modules as part of a 2-month clinical research virtual training to pharmacy and biotechnology engineering students attending the University of Algiers, and The School of Engineering & Biotechnology in Constantine, Algeria. The curriculum was designed to introduce students to the process of drug development and clinical research, including research and development, bioethics, good clinical practice, regulatory requirements, as well as post-market surveillance and real-world evidence.
Applying Health Literacy Principles to Clinical Research Studies: A Three-part Health Literacy Training
In the Spring of 2021, Sylvia Baedorf Kassis, MPH, Program Manager, facilitated a successful three-part virtual training entitled “Applying Health Literacy Principles to Clinical Research Studies” for clinical research professionals across the University of Utah.
The training covered:
- Health Literacy 101: The focus of this session was on the ethics/principles of health literacy as applied to the entire clinical research life cycle, including an introduction to co-developing materials with participants.
- Health Literacy in Action: The focus of this session was to expand on health literacy introduction to give specific examples of health literacy best practices applied to different types of research, including interventional and socio-behavioral studies. This session also included information on integrating participant feedback into the development and materials at various points across the clinical research life cycle (e.g., recruitment flyers, consent process, study questionnaires, study instructions, processes for pediatric studies, end of study communications).
- Health Literacy and Returning Research Results: This session focused specifically on managing and sharing aggregate research results (i.e. plain language summaries) with study participants and the community. Considerations for individual return of results were also introduced.
Capacity Building of Ethics Committees: an AVAREF-MRCT Center Collaboration
The African Vaccine Regulatory Forum (AVAREF) and the MRCT Center are initiating a partnership focused on capacity building of ethics committee members. AVAREF and the MRCT Center will collaborate to create and deliver an ethics training course for AVAREF country-members’ National Ethics Committees (NECs)/Institutional Review Boards (IRBs).
The purpose is to strengthen and augment the AVAREF country-member understanding of the ethical foundations of human participant research and their application to a variety of clinical research settings. An in-depth curriculum, offered virtually and leveraging cased-based learning, will focus on bioethics and best practices for the review and approval of clinical research, with the intention of enabling quality, efficiency, and the use of AVAREF standards and tools.
Read article here.
Successful GCP and MRCT training in Canada
The MRCT Center, in collaboration with Health Canada, conducted a 3-day training workshop in Ottawa, Canada, focused on Good Clinical Practice (GCP) and Multi-Regional Clinical Trials (MRCT), specifically the International Council of Harmonization (ICH) Guidelines ICH-E6(R2) and ICH-E17.
Seventy professionals from Canada participated in this successful in-depth and interactive training, including inspectors and reviewers from Health Canada as well as Canadian stakeholders from academia, hospitals, research institutes, CROs, and industry. Senior staff from Health Canada, Danish Medicines Agency, U.S. Food and Drug Administration (FDA), industry, and MRCT Center facilitated the interactive sessions. As one training participant said, “I’ve worked in this field for 13 years and this is the most helpful training I’ve been to.”
The objectives of the training were to:
- Describe the standards of Good Clinical Practice (GCP) and key considerations in Multi-Regional Clinical Trials (MRCTs) design as set out in ICH E6(R2) and ICH E17 guidance, with particular focus on how the guidelines are applied by Health Canada.
- Use case studies, to apply the changes of ICH E6(R2) addendum and ICH E17 to increase the acceptability of MRCT data by multiple regulatory authorities
- Demonstrate practical approaches that Health Canada may take to fulfill the requirements of ICH E6(R2) and ICH E17 consistent with ICH standards
For Regulators:
- Describe and demonstrate best practices to assess clinical trial regulatory submissions by Health Canada, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP and MRCT
- Describe inspection methodologies that may be taken by Health Canada to assess clinical trial conduct for alignment with ICH GCP and MRCT standards, including review of corrective actions.
For other Stakeholders:
- Gain better understanding and knowledge of Health Canada expectations with regards to compliance with the Canadian clinical trial regulations.
- Gain better understanding and knowledge of Health Canada GCP inspection processes to better prepare for an inspection
The MRCT Center is an APEC (Asia-Pacific Economic Cooperation) Training Center of Excellence for MRCT and GCP inspection and is endorsed as a training partner by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).
Successful APEC Center of Excellence Training Workshop on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP)
In April 2018, the MRCT Center held a 3 1/2-day training workshop at the Harvard Faculty Club focused on Multi-Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) as an APEC (Asia-Pacific Economic Cooperation) Pilot Center of Excellence (CoE), and specifically on ICH-E17 and ICH-E6(R2).
Twenty-two professionals from twelve economies participated, and all but one were governmental regulators. Senior staff from the U.S. Food and Drug Administration (FDA), Health Canada, Health Products Regulatory Authority (HPRA) Ireland, Pharmaceuticals and Medical Devices Agency (PMDA) Japan, industry partners, PhRMA, and MRCT Center facilitated the interactive sessions. The training was co-hosted by the APEC Harmonization Center (AHC).
The objectives of the workshop were to:
- Enhance regulatory cooperation in the APEC region on the evaluation and regulation of MRCTs
- Demonstrate practical approaches to fulfilling the requirements of GCP as presented in ICH E6(R2)
- Describe the concepts of MRCTs and key considerations in MRCT design as presented in ICH E 17 guidance
- Increase the acceptability of MRCT data by multiple regulatory authorities
With near unanimity, the participants rated the program as “excellent,” including the organization of the training, the faculty lectures, case studies/breakout groups, question and answer and “ask the expert” sessions, and the course materials. The vast majority of participants agreed that the training increased their knowledge and understanding of MRCTs and GCP and that the knowledge or techniques gained from this training will be practically useful in their field. Participants found the faculty knowledgeable of their respective training topics and networking with other participants was helpful. Based on this training, participants envisioned what they will do differently when they go back to their place of work.
Successful ICH E6 (R2) and GCP Pilot Training Workshop
The MRCT Center held a 3-day training workshop on International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6(R2) at Harvard Faculty Club last month.
Twenty-five professionals from fourteen countries participated, approximately half were governmental regulators. Senior staff from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), industry partners and MRCT Center facilitated the interactive sessions.
The objectives of the workshop were to:
- Describe the standards of Good Clinical Practice (GCP) as set out in ICH E6 as well as the changes in the ICH E6(R2) revision, as applied to multinational design, conduct, oversight, reporting and review of regulated trials
- Describe models of implementation of the changes in the ICH E6(R2) addendum
- Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) consistent with revised standards (e.g., risk-based quality management).
- Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP
- Define inspection methodologies to assess clinical trial conduct for alignment with ICH GCP including review of corrective actions.
With near unanimity, the participants rated the program as “excellent,” including the overall quality of the training, the quality of instruction and the course materials and case studies, the ability and opportunity to get questions answered and to interact, and the ability to gain a better understanding of the topic that will help them to implement these concepts. Participants said that the training improved their skills in GCP, gave them a better understanding of the overall conducting of clinical trials and a better understanding for interpretation of the data. Participants appreciated the opportunity to exchange experiences with colleagues from other countries and to ask questions of regulators.
