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.
Faculty Director Barbara Bierer, MD, traveled to Mexico City, Mexico, in February to learn more about the national preparedness for clinical trials.
A number of changes have been introduced in the country that have served to decrease the times for review while improving human participant protections. Anyone interested in further information or to be involved, please contact mrct@bwh.harvard.edu.
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.
