Focus Area: Capacity Building

Global Regulatory Engagement

Global Regulatory Engagement

Regulatory issues in different countries and in different regions of the world impact the conduct, efficiency, and oversight of clinical trials.  Our approach has been to work with representatives of the global clinical trial ecosystem to identify major issues in international clinical trial practice. We strive to promote a country-specific and culturally relevant approach.

In today’s global environment, there are numerous challenges to expanding clinical research sites globally, such as differing regulations and processes, variability in staff availability and training, inadequate hospital/clinical sites and laboratories, lack of supply chain infrastructure, concerns related to drug shipping/storage, currency devaluation, and governmental instability. Collaborative and harmonized efforts are critical for building capacity in clinical research in these new geographic regions. There is a need for targeted engagement with regulators, national ethics committees, and influential thought leaders to develop trusted partnerships with a shared mission of improving the ethics, design, conduct, and oversight of multi-regional clinical trials. The MRCT Center is working with diverse stakeholders to advance clinical research in new geographic regions, including Africa, the Middle East, Southeast Asia, and Latin America.

Objectives

  • Work closely with in-country leaders to determine tractable solutions to regulatory reform issues and ethics review
  • Collaborate with clinical trial stakeholders to understand and harmonize efforts to build capacity in clinical research
  • Build individual and systems capacity for regulatory and ethics review, cooperation, and reliance
  • Help establish sustainable infrastructure, operations, and expertise to enable training and continuous learning

Building Capacity for Ethics Review of Clinical Research Across Africa

Collaborating with international and local organizations to build capacity for research ethics committees across Africa and worldwide. For more information, click here.

Research Ethics Committee Systems Optimization

Building Capacity for innovative multi-country clinical trials in South-East Asia

The MRCT Center has worked together with academic institutions in South Korea to build capacity for clinical trials for more than a decade. For half a decade, the MRCT Center has collaborated on an innovative approach to setting up a three-country study in South-East Asia involving integrative therapies with a common endpoint. The MRCT Center developed a self-monitoring toolkit and provides recommendations on study design and expert guidance to support optimal study conduct.

Key Milestones related to the MRCT Center’s work in South-East Asia

Contact mrct@bwh.harvard.edu for more information.

Regulatory Reform in India

From 2013 to 2019, the MRCT Center worked closely with leaders in India to determine tractable solutions to regulatory reform issues, many of which deterred both for-profit and not-for-profit sponsors from conducting trials in the country. The MRCT Center worked with government officials, industry stakeholders, investigators, and others to develop alternative reforms that would not only reinvigorate the industry but also ensure the welfare of trial participants.

Key Milestones related to the MRCT Center’s work in India

  • July 2019: Published article with update about the evolving regulatory landscape for clinical trials in India
  • May 2019: The MRCT Center, in collaboration with Ropes & Gray LLP, hosted a special presentation and discussion with the Drugs Controller General of India to discuss the final New Drugs and Clinical Trials Rules, 2019, that were released in March, 2019 by India’s Ministry of Health and Family Welfare
  • March 2019: New rules released in India
  • December 2018: Published article about the evolving regulatory landscape in India
  • June 2018: Meetings with regulators, investigators, and industry in Delhi and Mumbai, India
  • March 2018: Submitted comments on updated draft rules in India
  • May 2017: Submitted comments on draft rules in India
  • March 2017: Additional meetings with representatives in India
  • March 2016: Meetings with regulators, investigators, representatives of industry, academia, non-profit organizations and patient advocacy groups in Delhi and Mumbai, India
  • October 2015: Meetings with regulators and thought leaders in Delhi, India
  • November 2014- January 2015: Publications in Financial Express, Business Line, and Bloomberg BNA related to clinical trial regulations in India and proposed amendments to Drugs and Cosmetics Act.
  • January 2014: Output of January 20 and 21, 2014, Roundtable included a draft of detailed recommendations embodying the consensus of different stakeholders, including leading academicians, investigators, industry representatives, and government officials. This document also suggested additional issues that the Ministry of Health and Family Welfare, Government of India, may wish to reconsider when implementing clinical research regulatory reform in India.

    Contact mrct@bwh.harvard.edu for more information.

    Multi-Regional Clinical Trial Guidance in China

    From 2015 to 2017, in response to the China Food and Drug Administration (CFDA) issuing a Draft Guidance on Multi-Regional Clinical Trials that set forth requirements for clinical trials in China, the MRCT Center, in collaboration with Peking University, developed scientific principles upon which to ground decision-making for MRCTs.

    Key Milestones related to the MRCT Center’s work in China

    • March 2017: Patient-Centric Clinical Trials Conference in Shanghai
    • September 2016: China FDA Training at Yale University
    • May 2016:  Global Simultaneous Drug Development Workshop in Beijing
    • October 2015: Workshop in Beijing
    • June 2015:
      ◦ Roundtable in Shanghai
      ◦ Launched Consistency and Region Working Group
    • April 2015: First roundtable teleconference
    • March 2015: Launched project with Peking University

      Contact mrct@bwh.harvard.edu for more information.

      Project Resources

      • Publication

      January 23, 2025

      Analysis of the Choice of Control in Acupuncture Clinical Trials Involving Patients with Breast Cancer ›
      • Publication

      June 24, 2024

      Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials ›
      • Publication

      August 29, 2023

      The Unresolved Challenge of Triage ›
      • Public Comments

      July 30, 2023

      Response to the proposed revision of the EU general pharmaceuticals legislation ›
      • Publication

      April 26, 2023

      Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations ›
      • Publication

      January 28, 2023

      Establishing a Global Regulatory Floor for Children’s Decisions about Participation in Clinical Research ›
      • MRCT Sponsor Resource
      • Presentation

      December 14, 2022

      MRCT Center 2022 Annual Meeting Slides ›
      • Publication

      October 22, 2022

      Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinate multinational study ›
      • Public Comments

      August 22, 2022

      Draft of New Drugs, Medical Devices and Cosmetics Bill ›
      • Publication

      June 17, 2022

      Developing and Implementing a Self-Monitoring Toolkit For a Coordinated Multinational Randomized Acupuncture Trial ›
      • Annual Report

      December 4, 2019

      2019 MRCT Center Impact Report ›
      • Publication

      July 1, 2019

      Post-Submission Update: The Evolving Regulatory Landscape for Clinical Trials in India ›
      • Annual Report

      December 5, 2018

      2018 MRCT Center Impact Report ›
      • Publication

      December 3, 2018

      The Evolving Regulatory Landscape for Clinical Trials in India ›
      • Publication

      July 13, 2018

      Reimagining Health Data Exchange: An Application Programming Interface-Enabled Roadmap for India ›
      • Public Comments

      March 16, 2018

      Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations ›
      • MRCT Sponsor Resource
      • Public Comments

      May 30, 2017

      Regulation of New Drugs and Clinical Trials Rules: Comments and Recommendations ›
      • Presentation

      October 13, 2016

      Multi-Regional Clinical Trials (MRCTs): Practice and Issues of Multi-Regional Clinical Trials’ Global Acceptance ›
      • Presentation

      March 9, 2016

      Webinar for India Regulatory Update ›
      • MRCT Sponsor Resource
      • Presentation

      October 26, 2015

      ICH E17 Scientific and Regulatory Workshop Slides ›
      • Publication

      October 21, 2015

      Indian Ministry Amends Informed Consent Rules ›
      • MRCT Sponsor Resource
      • Presentation

      October 14, 2015

      India: Progress and Opportunities ›
      • Public Comments

      August 11, 2015

      Comments to China FDA on resolving the backlog, Chinese Translation ›
      • Public Comments

      August 11, 2015

      Comments to China FDA on resolving the backlog ›
      • Presentation

      March 30, 2015

      MRCT Center Pre Conference Survey Slides ›
      • Publication

      January 23, 2015

      India’s Proposed Amendments to the Drug and Cosmetics Act ›
      • Public Comments

      January 11, 2015

      Drugs and Cosmetics Amendment Bill Comments and Recommendations ›
      • Presentation

      December 3, 2014

      Harvard MRCT India Regulatory Update, Causality and Compensation ›
      • Publication

      December 1, 2014

      Clinical Trial Research is No Crime ›
      • Publication

      November 25, 2014

      CT Regulation in India: Science of Social Justice? ›
      • Publication

      November 3, 2014

      Clinical Trials, a Lost Opportunity for India ›
      • Public Comments

      June 18, 2014

      Comments to Draft Rules to Amend the Drugs and Cosmetics Rules ›
      • Proceedings

      January 21, 2014

      Implementation Roundtable: Follow Up on Regulatory Changes Relating to Clinical Trials in India ›

      Virtual DSMC Training in the Philippines

      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.

      Self-assessed Competencies of Clinical Research Professionals and Recommendations for Further Education and Training

      Publication

      Published on: March 31, 2022

      Published in: Therapeutic Innovation & Regulatory Science

      The Joint Task Force for Clinical Trial Competency (JTF) conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework version 3.1. The results were analyzed based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. Respondents with professional certification self-assessed their competencies in all domains at higher levels than those without professional certification. The survey demonstrated that irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics. These results validate and extend the recommendations of a similar 2016 JTF and other surveys. We further recommend that clinical and translational research organizations and clinical sites assess training needs locally, using both subjective and objective measures of skill and knowledge.

      View Article

      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.

      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.