The Joint Task Force for Clinical Trial Competency (JTF) has released the Draft Version 2.0 of the Harmonized Core Competency Framework for public comment. This is an effort of a multi-stakeholder, widely representative workgroup from across the global clinical research community.
The original Framework was revised based on suggestions from implementers and stakeholders worldwide, and the JTF invites further comments on Draft Version 2.0 of the Framework. Download the Framework and learn more about the initiative on the JTF website.
The Joint Task Force for Clinical Trial Competency (JTF) was convened in 2013 to develop a single set of professional competency standards for clinical researchers worldwide. As such, the group brought together a diverse group of stakeholders representing various roles in the research community. The JTF’s Harmonized Core Competency Framework (Version 1.0) reflects this universality. Since its release in 2014, the Framework has been used across the globe to develop training programs, professional development pathways, job descriptions, and more.
Later in May 2017, the JTF will post the Final Draft of Harmonized Core Competency Framework (Version 2.0) on for public comment.
We invite you to visit the JTF website to learn more about the JTF and the Framework. Please contact the JTF with questions or to share how you have utilized the framework.
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 December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.
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 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.
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.
