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May 30, 2023 | Ethical Review of DCTs: Tools, Resources and Best Practices Webinar
The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). We invite you to join us on June 20, from 10 – 11 AM ET, for a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”During the webinar, Barbara Bierer (MRCT Center), Pam Tenaerts (Medable) and Leanne Madre (Medable) will present a framework, recommendations, and tools organized around 3 DCT domains: People, Remote Data Collection, and Data Oversight. Best practices for the ethical review, approval, and conduct of DCTs will be provided.
We invite clinical trial stakeholders (IRB/ECs, HRPP, sites, sponsors, investigators, and others) to register for the webinar. Please click on the following link: https://conta.cc/3WzhdT0
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May 04, 2023 | Accessibility by Design (AbD) Toolkit is Released
The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.
On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.”
The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research.
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Mar 24, 2023 | The MRCT Center Glossary as a Global Standard for Plain Language: Announcing a Collaboration with CDISC
Clinical research is essential for the discovery of new treatments and medical interventions that advance public health and medicine. Yet clinical research is complex, and scientific concepts are often complicated to explain. Several organizations have developed health- and disease-specific glossaries, which are often technical or intended for scientific stakeholders. Even glossaries developed for the general public are more focused on medicine and health, not research.
As a result, the MRCT Center developed a comprehensive and publicly available plain language glossary of clinical research terms and procedures—built collaboratively with patients, caregivers, and other clinical research industry stakeholders. Today we announce a collaboration between the MRCT Center and CDISC to sustain and expand the potential of this resource to provide standardized and harmonized plain language options for the technical language that is often used in participant-facing documents and materials. > MORE
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Nov 08, 2022 | MRCT CENTER VIRTUAL TRAINING INSPIRES LECTURERS IN INDONESIA
In October 2022, the MRCT Center delivered four modules as part of a virtual training to provide advanced learning for public and private university lecturers who teach in undergraduate and graduate biotechnology degree programs in Indonesia. > MORE
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Sep 26, 2022 | 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. > MORE
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Apr 25, 2022 | 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.
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Feb 24, 2022 | The MRCT Center submitted public comments to the National Institutes of Health (NIH)
The MRCT Center submitted public comments to the National Institutes of Health (NIH) “Request for Information on Proposed Updates and Long-Term Considerations for the NIH Genomic Data Sharing Policy,” published in the Federal Register on November 30, 2021. > MORE -
Jan 18, 2022 | AACI Commentary: Promoting Equity by Design in Clinical Trials by Dr. Barbara Bierer and Dr. Timothy Rebbeck
The January 2022 Association of American Cancer Institutes (AACI) commentary entitled “Promoting Equity by Design in Clinical Trials”, is written by MRCT Center Faculty Director Dr. Barbara Bierer and Dr. Timothy Rebbeck, Associate Director, Diversity, Equity and Engagement at Dana-Farber/Harvard Cancer Center. Read now
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Dec 07, 2021 | MRCT Center releases 2021 Impact Report
The MRCT Center 2021 Impact Report has been released. This year, our report is digital and interactive. > MORE -
Nov 05, 2021 | 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. > MORE -
Oct 30, 2021 | 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.
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Sep 01, 2021 | Listen to Dr. Barbara Bierer on the Clinical Trial Podcast
Listen to Dr. Barbara Bierer speak with Kunal Sumpat on the Clinical Trial Podcast about Diversity, Inclusion, and Equity in Clinical Research.
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Jul 15, 2021 | In Journal of Clinical and Translational Science: “Fair payment and just benefits to enhance diversity in clinical research” by MRCT Center colleagues
MRCT Center Faculty Director Barbara Bierer, Executive Director Sarah White, Senior Advisor Luke Gelinas, and Senior Advisor David H. Strauss, authored an article in the Journal of Clinical and Translational Science on “Fair payment and just benefits to enhance diversity in clinical research.”
Link to article.
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Jul 14, 2021 | 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. -
Jul 08, 2021 | “Navigating the ethics of remote research data collection” in Sage Journals: Clinical Trials by MRCT Center colleagues
MRCT Center Senior Advisor Luke Gelinas, Project Manager Walker Morrell, Executive Director Sarah White and Faculty Director Barbara Bierer authored an article in Sage Journals: Clinical Trials on “Navigating the ethics of remote research data collection.”
Link to article.
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Jul 02, 2021 | Dr. Barbara Bierer in ASH Clinical News “Breaking Down Barriers, Building Up Trust”
ASH Clinical News spoke with MRCT Center Faculty Director, Dr. Bierer about the lack of inclusivity in clinical trials, its implications, and efforts to strengthen the applicability of clinical trial results.
Link to article
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May 25, 2021 | “Trial Reporting and the Clinical Trials Enterprise” in JAMA Internal Medicine by MRCT Center Program Director, Dr. Deborah Zarin and Dr. Robert Califf
MRCT Center Program Director Dr. Deborah Zarin authored invited commentary in JAMA Internal Medicine with Dr. Robert Califf: “Trial Reporting and the Clinical Trials Enterprise.” Discussing how trial reporting has evolved and why academic medical centers must double down on efforts to ensure complete and accurate reporting.
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May 07, 2021 | 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. > MORE
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Mar 18, 2021 | MRCT Center in Science Magazine: “Justice, diversity, and research ethics review”
Published in Science Magazine “Justice, diversity, and research ethics review: It is time for institutional review boards and research ethics committees to address the ethics of inclusion” by MRCT Center Faculty Director Barbara Bierer, Executive Director Sarah White and Senior Advisor David Strauss. Read now
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Dec 18, 2020 | 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). -
Nov 03, 2020 | MRCT Program Director Deborah Zarin in STAT’s Pharmalot “Critics say new NIH policy on scientific data sharing falls short”
MRCT Program Director, Deborah A. Zarin commented on the National Institute of Health’s release of its final policy for managing and sharing publicly funded scientific data in STAT’s Pharmalot.
Read article here
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Oct 02, 2020 | In Science Magazine, “How to fix the GDPR’s frustration of global biomedical research” with MRCT Faculty Co-Director, Mark Barnes and Senior Advisor, David Peloquin
In Science Magazine, “How to fix the GDPR’s frustration of global biomedical research”, MRCT Faculty Co-Director, Mark Barnes and Senior Advisor, David Peloquin, both of Ropes and Gray, along with Barbara Bierer and colleagues, analyzed challenges to the European Union’s General Data Protection Regulation to share biomedical research data beyond the EU.
Read article here.
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Sep 08, 2020 | In BioCentury, Dr. Barbara Bierer discusses “Biopharmas must address the reality of racial disparities in health outcomes exposed by COVID-19”
In the second essay in BioCentury’s 28th Annual Back to School package, the reality of racial disparities in health outcomes that’s been exposed by the #COVID19 pandemic.
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Aug 25, 2020 | Dr. Bierer discusses Diversity in Clinical Research on the Clinical Trials Guru podcast
Dr. Bierer discusses Diversity in Clinical Research on Dan Sfera’s Clinical Trials Guru podcast. > MORE
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Aug 20, 2020 | Dr. Bierer is a guest on the Clinical Research Podcast with ECRG Media
Dr. Bierer discusses “How COVID-19 and A Lack of Diversity has Affected Clinical Trials” on the Clinical Research Podcast with ECRG Media. > MORE
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Aug 18, 2020 | Deborah A. Zarin is featured in STAT’s Pharmalot’s article about FDA penalties for clinical trial sponsors that don’t share data
Deborah A. Zarin is featured in STAT’s Pharmalot’s “FDA finalizes penalties for clinical trial sponsors that don’t share data, but critics say they fall short.” Read article
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Aug 18, 2020 | Deborah A. Zarin featured in Transparimed’s “Patient hopes dashed as FDA fails to tackle hidden clinical trial results.”
Deborah A Zarin is featured in “Patient hopes dashed as FDA fails to tackle hidden clinical trial results” in Transparimed. Read now
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Aug 14, 2020 | Dr. Barbara Bierer is a guest on the Sree Sreenivasan Daily, Global Show podcast
MRCT Center Faculty Director Dr. Barbara E. Bierer had a thoughtful and informative discussion on Sree Sreenivasan‘s Daily, Global Show discussing COVID Clinical Trials and the need for diversity in clinical research. > MORE
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Aug 06, 2020 | The MRCT Center Announces Newly Published Guidance Addressing Achieving Diversity, Inclusion, and Equity in Clinical Research
The MRCT Center announces the release of The MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, accompanied with practical resources, tools, and case studies, available to download. Read the Brigham and Women’s Hospital press release
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Jun 29, 2020 | Dr. Barbara E. Bierer discusses “COVID Trials Threatened by Shifting Surges” in MedPageToday
“COVID Trials Threatened by Shifting Surges” — MRCT Center Faculty Director, Dr. Barbara E. Bierer, discussed the state of clinical trials in the COVID-19 era, the need for clinical trial networks to be in place beforehand to speed broad multisite collaborations and the benefit of the COVID-19 Collaboration Platform in MedPageToday. Read article
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Jun 19, 2020 | Mark Barnes co-authors a special report in New England Journal of Medicine
Mark Barnes, MRCT Center Faculty Co-Director co-authored a special report in New England Journal of Medicine “Challenges of “Return to Work” in an Ongoing Pandemic.”
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Jun 13, 2020 | In Science Magazine, Dr. Barbara Bierer describes the COVID-19 Collaboration Platform
In Science Magazine, MRCT Center Faculty Director Barbara Bierer along with her COVID-19 Collaboration Platform colleagues details the need for a home for clinical trial protocols that are available for collaboration.
“To increase the power of RCTs, we have created a pilot repository for RCT protocols led by principal investigators who are open to various levels of collaboration. On the COVID-19 Collaboration Platform (CovidCP.org), researchers can submit their draft or completed protocols and find collaborators.
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May 14, 2020 | Deborah A. Zarin featured in STAT’s The Pharmalot View
MRCT Center Program Director, Deborah A. Zarin contributed to STAT’s The Pharmalot View “Where’s the data? In a pandemic, now is no time to sit on Covid-19 trial results.”
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May 07, 2020 | Response to European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR)
In response to the European Commission’s request for feedback regarding the General Data Protection Regulation (GDPR), Mark Barnes and Barbara Bierer, MRCT Center Faculty Co-directors, and Senior Advisor David Peloquin along with Rita Lawlor, Biobank Director & Research Coordinator, ARC-Net Research Centre, University of Verona, Italy, submitted feedback. -
Apr 28, 2020 | Diagnostic Testing for COVID-19: Considering False Positive and False Negative Results by Deborah A. Zarin, MD, MRCT Center Program Director and Joseph Lau, MD
Diagnostic tests for COVID-19 are central to most proposed plans for relaxing physical distancing and related policies. > MORE -
Jan 25, 2020 | Featured on Science Friday: Dr. Deborah Zarin, MRCT Center Program Director of Advancing the Clinical Trial Enterprise
Listen to Dr. Deborah Zarin, MRCT Center Program Director of Advancing the Clinical Trial Enterprise and former director of ClinicalTrials.gov with Science Magazine journalist, Charles Piller on Science Friday discussing recent investigations on ClinicalTrials.gov reporting practices. > MORE
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Dec 10, 2019 | Financial Times awards MRCT Center Faculty Co-Director, Mark Barnes, “2019 Legal Innovator of the Year”
[New York, NY., December 9, 2019]– At the prestigious December 9 Financial Times “Innovative Lawyers” awards, an annual contest that honors elite law firms, companies and legal service providers, Mark Barnes, JD LLM Multi-Regional Clinical Trials Center Faculty Co-Director and health care partner at Ropes & Gray, was honored with the “Legal Innovator of the Year” award, given to one exceptional lawyer. > MORE -
Jun 25, 2019 | OptumLabs and MRCT Center Award Grants for Replication of Drug Clinical Trials Using Real-World Data
[CAMBRIDGE, Mass., June 25, 2019]– OptumLabs and the MRCT Center announced that two academic institutions were awarded grants to support replication of established clinical trials through the use of electronic health record (EHR) and claims data, which could help improve clinical trial design and drug development. > MORE
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May 03, 2019 | Kick-off of Proactive Safety Surveillance Project
As the launch to the project, on May 3, 2019, the MRCT Center invited over 40 representatives from industry, academia, government, and patient advocacy groups to discuss a vision for aglobal, cooperative model of a more proactive, predictive safety surveillance system than exists today. > MORE
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Apr 22, 2019 | Launch of Proactive Safety Surveillance Initiative
Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders. > MORE
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Apr 22, 2019 | New Rules Released in India
On March 19, 2019, the Ministry of Health and Family Welfare of India released the “New Drugs and Clinical Trials Rules, 2019.”[1] These rules included significant definitions, clarifications, opportunities, and expectations that, together, improved the clinical trial regulatory environment in India. > MORE
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Mar 29, 2019 | MRCT Center participated in two Health Literacy workshops
Plain Language for Health. A Writing and Design Workshop for Health Research and Practice (March 28-29)
The MRCT Center co-sponsored a two-day workshop held by Tufts on March 28th-29thfocused on how to use plain language principles to improve research-related communications. Approximately 70 attendees from academic medical centers, the public health field and pharmaceutical companies attended. > MORE
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Mar 13, 2019 | Third Meeting of the MRCT Center / Ropes & Gray LLP R3 Meeting Held in Washington, DC
The third Research, Development, and Regulatory Roundtable (R3) was held at the Washington, D.C. offices of Ropes & Gray LLP on March 7, 2019. Stakeholders convened to discuss Secondary Uses of Health Care Data for Clinical Trial Recruitment: Legal and Regulatory Ambiguity. Afterward, attendees were updated on developments related to the application of the EU General Data Protection Regulation (GDPR) to research.
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Mar 10, 2019 | Published Article in American Journal of Bioethics
The MRCT Center recently authored ‘Universal Funder Responsibilities That Advance Social Value’ in the American Journal of Bioethics.
This article outlines the responsibilities of, and specific recommendations for, research funding organizations to promote the novelty, significance, rigor, and impact of research they fund.
To read the article, click here. > MORE
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Mar 05, 2019 | Dr. Barbara Bierer speaks at African Vaccine Regulatory Forum (AVAREF)
Initially created in 2006 by the World Health Organization, the African Vaccine Regulatory Forum (AVAREF) was created as an informal capacity building platform dedicated to improving the regulatory and ethical oversight of interventional clinical trials in Africa. In 2016, a revised governance structure was agreed upon and the remit of AVAREF was expanded to include all interventional clinical trials in Africa. > MORE
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Mar 01, 2019 | 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. > MORE
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Feb 24, 2019 | Proceedings Available from MRCT Center’s 2018 Annual Meeting
The MRCT Center 2018 Annual Meeting was held on December 5, 2018 and convened a diverse group of approximately 80 stakeholders focusing on global clinical trials. > MORE
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Nov 28, 2018 | Template Data Sharing Governance Tools Released
In order to maximize the interoperability of anonymized data and reduce the contractual barriers and administrative burden(s) of data sharing, the MRCT Center developed three harmonized governance tools as part of the PCORI Open Science Pilot Project. > MORE
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Nov 08, 2018 | Second Meeting of the MRCT Center/ Ropes & Gray LLP R3 held in New York
The second Research, Development, and Regulatory Roundtable (R3) was held at the New York City offices of Ropes & Gray LLP On November 8, 2018. Stakeholders convened to discuss Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations.
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Aug 28, 2018 | Introducing the Research, Development, and Regulatory Roundtable (R3) of Ropes & Gray LLP and the MRCT Center
The R3 provides a periodic, non-partisan forum wherein policymakers, regulators, legal counsel, and academicians may present, discuss, and deliberate cutting-edge issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. > MORE
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Jul 30, 2018 | Recent Publications
Dr. Barbara Bierer, MRCT Center Faculty Director, co-authored Development of a Plain-Language Library of Educational Resources for Research Participants, recently published in the Journal of Clinical and Translational Research.
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Jul 30, 2018 | MRCT Center and Ropes & Gray GDPR Conference
In collaboration with Ropes & Gray LLP, the MRCT Center hosted a closed, one-day roundtable on Monday, July 30th. -
Jun 22, 2018 | Bioethics Collaborative Meeting Summary Notes Released
The MRCT Center Bioethics Collaborative is delighted to share a very brief summary of the April 24, 2018 discussion related to Return of Individual Results to Research Participants and Axes of Communication. Read the summary here
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Apr 25, 2018 | 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). -
Mar 12, 2018 | Global Regulatory Engagement: Mexico
Faculty Director Barbara Bierer, MD, traveled to Mexico City, Mexico, in February to learn more about the national preparedness for clinical trials. > MORE
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Feb 05, 2018 | MRCT Center Bioethics Collaborative published framework and toolkit on Expanded Access
The MRCT Center Bioethics Collaborative has published a framework and toolkit entitled Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians, and Institutional Review Boards.
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Dec 21, 2017 | MRCT Center 2017 Impact Report Released
On December 6, 2017, at the MRCT Center Annual Meeting, we released the MRCT Center 2017 Impact Report, Harmonizing the Clinical Trial Ecosystem.
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Nov 10, 2017 | 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. > MORE
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Oct 16, 2017 | Plain Language Summary Guidance Document Submitted to the FDA – open for comments
The MRCT Center, in collaboration with TransCelerate Biopharma, Inc. submitted to FDA for consideration a draft guidance document on provision of plain language summaries for study participants. > MORE
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Sep 07, 2017 | Version 2.0 of Core Competency Framework for Clinical Research Professionals Released
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. > MORE
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Aug 28, 2017 | Post-Trial Responsibilities Framework Released
We have released the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines. This framework consists of two parts: a Guidance Document (Version 1.1) and a Toolkit (Version 1.0) . -
Jun 14, 2017 | Harmonized Core Competency Framework Version 2.0 Released for Public Comment
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. > MORE
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May 09, 2017 | Joint Task Force for Clinical Trial Competency Launches Website
The Joint Task Force for Clinical Trial Competency (JTF) has launched its new website: https://mrctcenter.org/clinical-trial-competency. This site hosts the Harmonized Core Competency Framework, as well as the news about the JTF’s latest initiatives, events, and resources.
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Apr 04, 2017 | Vivli Attains Non-Profit 501(c)3 Status
The MRCT Center is delighted to announce that Vivli has been approved as a 501(c)3 non-profit organization!
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Apr 03, 2017 | Data Authorship as an Incentive to Data Sharing
The MRCT Center, in collaboration with Harvard University and the Association of American Medical Colleges (AAMC), released a Sounding Board in the New England Journal of Medicine on the concept of data authorship, a designation and system of credit meant to recognize the efforts the data generators and data sharers.
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Mar 24, 2017 | Return of Aggregate Results Version 3.0 Released
The MRCT Center updated the MRCT Center Return of Aggregate Results Guidance Document and the MRCT Center Return of Aggregate Results Toolkit to incorporate and reflect the EU Guidelines on Summaries of Clinical Trial Results for Laypersons. > MORE
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Mar 07, 2017 | Proceedings and Presentations Available from MRCT Center’s 2016 Annual Meeting
The MRCT Center 2016 Annual Meeting was held on December 7, 2016 and was attended by about 80 stakeholders, including representatives from academia, governmental agencies, institutional review boards, the pharmaceutical industry, and non-profit organizations.
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Mar 03, 2017 | MRCT Center Endorsed as APEC Pilot Center of Excellence
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. -
Feb 15, 2017 | Individual Return of Results Principles Released
The MRCT Center Individual Return of Results workgroup developed principles that are directly relevant to the return of individual research results to research participants. These principles are summarized in a brief Principles Document.
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Feb 07, 2017 | New Publication by MRCT Center Faculty Co-Directors
In January 2017, MRCT Center Faculty Co-Directors, Dr. Barbara Bierer and Mark Barnes, JD, co-authored with Abram Barth and David Peloquin an article entitled, “HHS Finalizes Comprehensive Revisions to the Common Rule” published in Bloomberg BNA Life Sciences Law & Industry Report.
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Dec 14, 2016 | Principles Papers Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
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Dec 08, 2016 | Post-Trial Responsibilities Framework Version 1.0 Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released Version 1.0 of the MRCT Center Post-Trial Responsibilities Framework: Continued Access to Investigational Medicines – Guidance Document. > MORE
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Dec 08, 2016 | MRCT Center 2016 Impact Report Released
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
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Nov 01, 2016 | Core Competencies Workshop drew Participants from around the World
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.” > MORE
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Sep 14, 2016 | Register for the MRCT Center Annual Meeting
The MRCT Center will hold its 2016 Annual Meeting on December 7, 2016, at Harvard Faculty Club’s Loeb House in Cambridge, Massachusetts.
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Sep 14, 2016 | Register for October 19, 2016 Workshop: Core Competencies in Clinical Research
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.
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Aug 01, 2016 | Draft Principles for Return of Individual Results Available for Comments
A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.
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Jul 14, 2016 | Updated versions of Return of Results Guidance Document and Toolkit released
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field. > MORE
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Jun 15, 2016 | A Global, Neutral Platform for Sharing Trial Data
The MRCT Center spearheaded a Perspective in the New England Journal of Medicine that spells out the need and requirements for a global, neutral platform for sharing clinical trial data. > MORE
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Jun 15, 2016 | MRCT Center Announces the Formation of our new External Advisory Board
The MRCT Center is delighted to announce the launch of our new External Advisory Board which will have its inaugural meeting on June 29, 2016, at Harvard Faculty Club.
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Apr 29, 2016 | Proceedings available from The Future of Clinical Trials Data Sharing Conference
The MRCT Center, in collaboration with The Wellcome Trust, held a conference on “The Future of Clinical Trials Data Sharing” in London, U.K., March 21-22, 2016 with approximately 100 participants from academia, government, not-for-profit organizations, journal editors and industry. > MORE
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Mar 30, 2016 | Conference on the Future of Data Sharing
On March 21-22, 2016 at an invitation-only meeting at the Wellcome Trust in London, the MRCT Center and collaborators shared plans to launch a new not-for-profit organization, Vivli, charged with directing, implementing and governing a global clinical trial data-sharing platform. The plans for an approach whereby data from multiple sources can be integrated, enabling researchers to access and combine data across various platforms were deliberated. > MORE
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Mar 01, 2016 | Launch of Bioethics Collaborative
The MRCT Center is launching a new initiative–the Bioethics Collaborative.
The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together scholars, executives, and scientists from academia and industry to share, define, study, and propose ethical frameworks for topics including human subject protections, biospecimens, and research integrity. We will look at real-life settings as well as develop approaches to address emerging and unanticipated issues as the pace of research continues to accelerate. The Collaborative will be a neutral forum to provide ethical guidance on global clinical trials concerns. > MORE
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Feb 17, 2016 | Proceedings, Presentations and Annual Report Available from MRCT Center’s 2015 Annual Meeting
The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.
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Jan 27, 2016 | MRCT Center and Collaborators Published in Journal of Medical Ethics
A multi-stakeholder team, convened by the MRCT Center, published an article detailing use of a Protocol Ethics Toolkit to facilitate effective recognition, consideration and deliberation of critical clinical ethical issues in clinical trial protocols.
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Dec 29, 2015 | MRCT Center wins the 2015 Award for Excellence in Human Research Protection
The 2015 Awards for Excellence in Human Research Protection were announced on December 28th by Dr. Peter G. Goldschmidt, President and Founder of Health Improvement Institute, “The award program recognizes submissions that our judging panel determines have demonstrated excellence in promoting the well-being of human research participants.”
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Nov 03, 2015 | MRCT Center holds Regulatory and Scientific Workshop at Peking University
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. -
Oct 27, 2015 | The MRCT Center mourns the passing of Prof Ranjit Roy Chaudhury
We at the MRCT Center, with our friends and colleagues, mourn the passing of Padma Shri Prof Ranjit Roy Chaudhury, announced on the morning of October 27, 2015. -
Sep 21, 2015 | Register for MRCT Center’s Annual Conference
The MRCT Center will hold its 2015 Annual Conference in December. This conference offers Executive and Steering Committee and Working Group members as well as interested stakeholders the opportunity to meet face-to-face with each other and learn about current projects of the MRCT Center.
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Aug 05, 2015 | Launch of Data Sharing Working Groups
The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women’s Hospital (MRCT Center), the Wellcome Trust, and the Arnold Foundation have spearheaded a major initiative related to sharing of clinical trials data, to enable stakeholders to comply with PhRMA, EFPIA, EU and IOM guidelines on clinical trial data sharing: sharing participant level data with researchers.
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Jul 17, 2015 | MRCT Center Transitioned to the Division of Global Health Equity
As of July 1, 2015, the MRCT Center has moved administratively to the Division of Global Health Equity, under the leadership of Dr. Paul Farmer, at the Brigham and Women’s Hospital (BWH), a Harvard teaching hospital. The Division of Global Health Equity serves as an academic and research home for more than 40 Harvard and BWH faculty who are engaged in teaching, patient care and research around the world and domestically.
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Jul 13, 2015 | Launch of Consistency and Region Working Group
The MRCT Center launched a new working group on June 18, 2015, as part of the MRCT Center’s partnership with Peking University.
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May 15, 2015 | Post-Trial Responsibilities Defined
The Post-Trial Responsibilities Working Group, sponsored by the MRCT Center at Harvard, was launched in February 2015 and is a multi-stakeholder group with 55 members from academia, industry, non-profit organizations, government, and patient organizations. Twelve countries are represented.
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Apr 30, 2015 | Committed Leaders Gather to Drive Clinical Trial Data Transparency Solutions
On March 30-31st, 2015, over seventy committed international stakeholders joined together at the Harvard Faculty Club in Cambridge Massachusetts to deliberate how to promote and coordinate clinical trials data transparency. Over the two day conference, renowned experts from academia, industry and others shared their organizational experiences in data sharing, distilled best practices, described lessons learned from case studies, reviewed recommendations from the Institute of Medicine report: Strategies for Responsible Sharing of Clinical Trial Data, and considered how best to put those recommendations into practice.
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Apr 10, 2015 | Improving ethical issues in clinical trials in developing countries
There are multiple ethical challenges for conducting multi-regional clinical trials in developing countries, such as whether patients in developing countries are free to participate in research if access to essential medicines is tied to research, and how informed consent can be assessed and risks and benefits understood when the element of choice is so different.
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Mar 31, 2015 | MRCT Center releases pre-conference survey results – shows commitment to data sharing across diverse stakeholder groups
On March 30-31st, 2015 over 70 committed international stakeholders joined together at the Harvard Faculty Club to discuss solutions to Clinical Trial Data Sharing.
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Mar 30, 2015 | Envisioning a Sustainable Clinical Trial Data Sharing Platform
MRCT hosted a Data Transparency Conference at Harvard, 30-31 March.
More than 70 participants from academia government, industry, and nonprofit organizations gathered at the Harvard Faculty Club for a 2-day conference focused on how to harness the full potential of participant level data sets for secondary use.
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Mar 23, 2015 | Standardizing Informed Consent Templates and Data Sharing Agreements
Revised ICF and DUA templates available.
Standardizing Informed Consent Forms (ICFs) and Data Use Agreements (DUAs) across multiple sponsors may considerably streamline the data sharing process.
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Mar 20, 2015 | Contributing to proposed Rule for Results Reporting of Clinical Trial Data
Comments submitted to NIH
In March, we submitted public comments to the National Institutes of Health in response to the Proposed Rule for Clinical Trial Registration and Results Submission. Our comments addressed the need for:
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Mar 05, 2015 | Capacity building in India
The MRCT Center at Harvard continues its active engagement in India. Most recently, important efforts to address regulatory issues have been expanded to develop tools and capacity in causality assessment of adverse events that occur during participation in clinical trials.
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Jan 13, 2015 | DSMB Training Workshop in Bangkok
MRCT Center at Harvard Executive Director Rebecca Li co-hosted a Data Safety and Monitoring Board (DSMB) Training Workshop in Bangkok in conjunction with the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) Thai Red Cross Conference on 13 January 2015.
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Dec 18, 2014 | Proceedings, Presentations and Annual Report Available from MRCT Center’s 2014 Annual Meeting
MRCT Center at Harvard 2014 Annual Meeting was held on 3 December 2014 and was attended by by more than 60 stakeholders from governmental agencies, pharmaceutical industry, academia, patient advocates, media representatives and others. MRCT Center at Harvard’s Annual Progress Report 2014 was released at the meeting.
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Dec 03, 2014 | 2014 Annual Meeting
MRCT Center at Harvard hosts its third Annual Meeting in 2014 at the Loeb House, 17 Quincy Street, Cambridge, MA 02138.
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Dec 02, 2014 | 2014 Annual Meeting Dinner (for Harvard MRCT’s Executive and Steering Committees only)
MRCT Center at Harvard hosts the 2014 Annual Meeting Dinner at Henrietta’s Table for the welcoming of MRCT Center at Harvard Executive and Steering Committee members, as well as conference speakers.
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Nov 04, 2014 | MRCT Post Trial Responsibilities Conference Proceedings Available
MRCT Center at Harvard collaboratively with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School hosted a one-day open conference on post-trial responsibilities on September 18, 2014, at the Harvard Law School.
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Sep 18, 2014 | A Conference on Post-Trial Responsibilities: Ethics and Implementation
MRCT Center at Harvard and the Petrie-Flom Center at Harvard Law School co-host A Conference on Post-Trial Responsibilities: Ethics and Implementation.
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Feb 02, 2014 | MRCT Presents at IOM
MRCT Center at Harvard was asked to present their efforts on clinical trial data sharing at IOM on February 3, 2014. Both presentations were well received, and the IOM was receptive to suggestions made by MRCT.
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Jan 20, 2014 | MRCT Co-hosts Roundtable Discussion in India
MRCT Center at Harvard, the All India Institute of Medical Sciences (AIIMS) and Apollo Hospitals Research and Education Foundation (AHREF) co-hosted a two day roundtable to discuss issues surrounding clinical trials in India. The very productive sessions resulted in the attached Executive Summary and discussions with the Ministry of Health in India.
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Oct 21, 2013 | As Institute of Medicine committee convenes, Harvard researchers and pharmaceutical industry experts offer recommendations for expanding access to clinical trial data responsibly
Boston, MA – A new report by researchers from Harvard University and others in a working group convened by the Multi-Regional Clinical Trials Center (MRCT) at Harvard proposes recommendations for addressing a problem that has vexed drug regulators: how to expand public access to data from clinical trials while protecting patients’ privacy and weighing pharmaceutical companies’ business interests.
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Sep 30, 2013 | Informed Consent Subgroup Offers Comments to EMA
MRCT Center at Harvard Informed Consent Subgroup has submitted comments on EMA Draft Policy 0070. This subgroup is part of the second phase of MRCT’s efforts related to Clinical Trial Data Sharing and Transparency, called “Implementation and Solutions”.
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Aug 08, 2013 | Proceedings available: May 2013 MRCT and PFC Clinical Trial Data Sharing Conference
Proceedings are posted under “Resources” for the Clinical Trial Data Sharing and Transparency Conference, co-hosted by the MRCT Center and the Petrie Flom Center of Harvard Law School.
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Aug 05, 2013 | FDA Comments – No. FDA–2013–N–0271: Availability of Masked and De-identified Non-Summary Safety and Efficacy Data – June 2013
Harvard University’s Multi-Regional Clinical Trials Center (MRCT) submitted the following comments on FDA’s proposal, 78 Fed. Reg. 33421 (June 4, 2013), to make de-identified and masked clinical and preclinical data, from marketing applications submitted to FDA, available to external experts and others, as part of the Agency’s transparency initiative.
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Jul 31, 2013 | MRCT publishes in Bloomberg BNA
MRCT Co-directors Mark Barnes and Barbara Bierer co-authored a recent publication in the Bloomberg BNA Medical Research Law & Policy Report.
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Jul 11, 2013 | Declaration of Helsinki comments: Declaration of Helsinki, issued for public comment by the Counsel of the WMA in April 2013
MRCT Center at Harvard responded to the World Medical Association’s request for comments or potential revisions to the Declaration of Helsinki (DoH), which will reach its 50th anniversary in 2014.
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May 23, 2013 | Clinical Trial Data Sharing and Transparency Conference Draws Nearly 200 Participants
The Issues and Case Studies in Clinical Trial Data Sharing: Lessons and Solutions Conference, held on May 17th, 2013, drew close to 200 participants and proved to be an exceptional platform to discuss matters surrounding clinical trial data sharing.
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Mar 28, 2013 | First class of DSMB fellows attends workshop at SCT
The Multi-Regional Clinical Trial Center at Harvard has an initiative focused on training of Data Safety Monitoring Board (DSMB) members; this initiative is driven by a working group comprised of stakeholders from industry and academia and the 2013 class of DSMB Fellows were equally as diverse.
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Mar 18, 2013 | Announcement of Fellows and DSMB Training
The Data & Safety Monitoring Work Group is holding an all-day training session for eleven fellows on May 19, 2013.
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Feb 15, 2013 | MRCT PI Training and Competence Working Group – Collaboration Meeting
On February 15, 2013, the MRCT PI Training and Competence Working Group hosted a half-day focus group collaboration meeting at the Harvard Global Health Institute with Ingrid Klingmann (IMI/Pharmatrain), Bob O’Neill (FDA), Greg Koski (ACRES), Honorio Silva (ACRES) and Jason Nyrop (Deloitte) and Rohin Rajan (Deloitte). The objectives of the meeting included:
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