On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.
The MRCT Center continued to promote transparency and responsible sharing of clinical trial data. Vivli, the data sharing platform, was incorporated and awarded non-profit, tax-exempt status. The MRCT Center is developing fit-for-purpose prototype templates that will address governance issues in data sharing. Our training efforts have grown significantly this year. We hosted the first pilot training on ICH E6(R2), convening regulators and investigators from 14 countries. The MRCT Center Return of Results Workgroup completed the framework guidance and toolkit, which addresses the complexity of sharing genetic data. We have launched several new projects in 2017, two of which are related to the utility and limitations of real world evidence in regulatory decision-making. On our horizon is a new project to address the lack of diversity in clinical trials.
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.
The Joint Task Force (JTF) for Clinical Trial Competency has updated and released its Core Competency Framework Version 2.0 for use by clinical research professionals and staff worldwide.
The JTF has always recognized that the dynamic nature of the clinical research enterprise will necessitate the continuing revision of the Framework so that it meets the latest scientific, ethical and research challenges of clinical researchers.
In October 2016, the MRCT Center hosted the Core Competencies in Clinical Research Workshop, which brought together the JTF, a diverse group of representatives from the clinical research community, and stakeholders who have utilized the Framework in their own organizations. Case studies were presented to highlight real-world applications, to gather feedback on potential revisions, and to develop future objectives for the JTF. Following this Workshop, the JTF launched the Revisions Workgroup to evaluate changes to the Framework based on suggestions from implementers and stakeholders. The Revisions Workgroup evaluated suggested revisions against a rubric that measured impact, and relevance across the clinical research community, global applicability, and necessity.
The revised Core Competency Framework Version 2.0, which resulted from this process, was released on September 1, 2017.
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.
