The MRCT Center 2021 Impact Report

Each clinical trial participant should contribute to the evolving medical evidence base. This involves not only avoiding uninformative trials but also ensuring that all trials are reported completely and promptly so that they are available to inform future trials, as well as clinical and policy decisions. The MRCT Center’s goal is to develop standards for conducting and reporting clinical trials that can be used by investigators, funders, and IRBs to ensure that the decision to initiate a new clinical trial is made with knowledge of relevant completed and ongoing trials.

The MRCT Center’s key efforts in 2021 included promoting the use of landscape analyses prior to initiating a clinical trial, improved reporting of clinical trials to ClinicalTrials.gov and improving the informativeness of clinical trials. Our work continues in 2022 to define, study, and improve the quality of the medical evidence base.

Find out more about the Advancing the Quality of Clinical Trial Enterprise project.

The changing regulatory and ethics landscape demands continuous learning by regulators, ethics committee members, investigators, and site staff.

In 2021, the MRCT Center developed and delivered virtual trainings to audiences around the world.

• In collaboration with AVAREF, ethics committee chairs and members from 18 countries across Africa participated in a case-based virtual learning.
• Bioengineering students in Algeria were inspired by courses in drug development and clinical research.
• Graduate students and faculty in Indonesia learned about innovation in drug development and clinical trial methods.
• US based institutional IRB and HRPP program personnel applied principles of health literacy to their work.

As an APEC Center of Excellence, the MRCT Center pivoted to online learning to continue its educational mission: The successful “Interpretation and Application of ICH GCP E6(R2)” training has enrolled over 2,200 individuals from more than 90 countries globally, and over 17,000 modules have been accessed.

Upcoming trainings in 2022 include:

• Diversity, Equity and Inclusion (DEI) in Clinical Research
• Health Literacy
• Good clinical practice
• General considerations for clinical studies
• Planning and design of multi-regional clinical trials

Accurate health and research information from trusted, reliable sources has always been important, and the need has been illuminated by the COVID-19 pandemic. In 2021, leveraging the MRCT Center’s expertise in global clinical trials, health literacy, and diversity, equity and inclusion, we developed and disseminated a series of educational materials for patients, participants, and the public, for both adults and young people, shown here. The MRCT Center plain language Clinical Research Glossary, launched in June 2021, co-created with patients and patient advocates, is a useful resource both for content developers and the public. In addition, the MRCT Center worked to raise the voice of youth research advocates by developing a toolkit to assist trial investigators who are engaging young people in the planning of clinical trials/product development.

Looking towards 2022, the MRCT Center will continue the center-wide commitment to inclusion, transparency, and clear communication in research. This includes developing additional patient and public facing resources and translating resources and tools for patients and participants into other languages to support representation of diverse communities.

Find out more about the MRCT Center developed Community Resources.

The patchwork of privacy laws that apply to the processing of personal data, including clinical trial data, and in some cases restrict the transfer of such data across national boundaries, impedes the progress of science and public health and the use of personal data for secondary research. The MRCT Center remains at the forefront of analyzing and understanding the impact of these emerging data and biospecimen sharing and privacy laws and regulations.

In addition to the European Union’s General Data Protection Regulation (GDPR), which has been a focus of the MRCT Center for several years, recent years have seen a growing number of sector-specific and omnibus state privacy laws in the U.S., such as the CCPA/CPRA and recently-passed data privacy legislation in Colorado and Virginia.  Also of note, China enacted an omnibus data privacy law known as the Personal Information Protection Law (“PIPL”), which took effect in 2021. The MRCT Center continues to monitor the development of these laws and suggests strategies to help the research community comply with such laws, including through advocacy with relevant public authorities and industry stakeholders.

Find out more about the Impact of GDPR on Clinical Research project.

Sustaining momentum for more inclusive clinical research requires thoughtful and deliberate work. In the year after the release of MRCT Center’s Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, we remain dedicated to building inclusive and equitable approaches to clinical research. Upon publication of the guidance document, we pivoted to examine and promote strategies to increase the inclusion of underrepresented and underserved groups in clinical research including people with disabilities, people with limited English proficiency, non-English speakers, and others. We also began work with IRB and human participant protections professionals to develop DEI tools and resources to aid in clinical research protocol review and oversight. We plan to release these resources publicly in early 2022.

In response to stakeholder requests for further guidance on inclusivity in research, the MRCT Center launched and delivered the 11-month Leaning In Webinar Series that focused on practical approaches to improving diversity in clinical trials as well as how to plan for inclusion, implement recommendations, and sustain progress. In response to the call for accountability, we launched the development of Equity by Design in Clinical Research: A Metrics Framework to provide tools for monitoring of DEI in clinical research, in collaboration with representatives of relevant organizations. These organizations, as part of a convened DEI ‘Roundtable’, include: Association of Clinical Research Organizations (ACRO), Association of American Medical Colleges (AAMC), Alliance of Multi-Cultural Physicians, Biotechnology Innovation Organization (BIO), FasterCures, U.S. Food and Drug Administration (FDA), National Health Council (NCH), National Institutes of Health (NIH), and PhRMA.

In 2022, we will develop core training modules for clinical research practitioners and professionals focused on DEI in clinical research, including a compendium of case studies tailored to several health specialty areas.

We stand by our statement on racism. We stand by our support of health equity and social justice.

Find out more about the Diversity, Inclusion, and Equity in Clinical Research project.

Recognizing that only 12% of adults have proficient levels in health literacy, the clinical research industry must ensure that participant facing materials are clear and understandable; the COVID-19 pandemic affirmed the need for clear communications. The MRCT Center continues to focus on health literacy, creating resources to support all stakeholders along the research continuum.

In 2021, the MRCT Center provided training and capacity building to academic centers and organizations related to the principles and practices of health literacy. The MRCT Center developed and pilot-tested a health literacy training and checklist for IRBs. In addition, the MRCT Center successfully launched a plain language Clinical Research Glossary, co-created with patients and patient advocates, and a useful resource both for content developers and the public. Expansion efforts to make the Clinical Research Glossary a larger, more comprehensive, and sustained resource, incorporating accessibility and translation considerations, are underway for 2022.

Find out more about the Health Literacy in Clinical Research project.

Most participants want their individual research results, yet few receive them. As sponsors and investigators work to increase trust in research, implementation of this practice is necessary.

In 2017, the MRCT Center released the Return of Individual Results to Participants Principles, Recommendations Document, and Toolkit. Experience has demanded focused additions to the existing guidance to lower the barrier to entry and promote adoption of returning results to participants.

In 2021, the MRCT Center initiated a Taskforce to identify gaps in the existing guidance, update recommendations, and frame practical approaches for the future. New and updated deliverables are planned for launch in early 2022.

Find out more about the Return of Individual Research Results project.

Safe and effective therapeutic products are needed for children. Many countries, however, do not have established regulatory frameworks for research in children. The MRCT Center is committed to ensuring children benefit from clinical research, as well as elevating the youth voice in all aspects of clinical trials and product development.

In 2021, the MRCT Center kicked off an FDA-funded webinar series focused on critical aspects of pediatric clinical trials. The first in this 5-part series (6 & 7 October, 2021) focused on lessons learned from COVID-19 to discuss the initiation of pediatric clinical trials and the infrastructure needed to support the international pediatric clinical trial enterprise appropriately. The series will continue in 2022 with topics related to: (1) Enhancing the pediatric voice in research from study design to assent; (2) Ethical challenges during review of pediatric clinical trials; and (3) Regulatory convergence and international cooperation to facilitate pediatric research. Furthermore, ethical aspects and impacts of regional and national health technology assessment bodies on pediatric product development will be the focus of a May 2022 Brocher Foundation meeting in Switzerland.

In 2022, we will finalize and release a series of tools and resources to assist in harmonizing the regulatory frameworks for research in children as well as a suite of pediatrics informational resources to assist youth considering participation in clinical trials.

Find out more about the Promoting Global Clinical Research in Children project.

Discussion by and collaboration among diverse stakeholders is needed to make progress on persistent and emerging ethical issues in global clinical trials. The MRCT Center Bioethics Collaborative convenes representatives from academia, industry, patient groups, ethics committees, and government to address these issues in the context of multi-national clinical trials.

The MRCT Center hosted four virtual meetings in 2021:

• February 2021: Decentralized Clinical Trials
• April 2021: Community Engagement
• June 2021: Limited English Proficiency and Translation of Study Materials
• October 2021: Navigating Interactions Between DMCs and IRBs

The MRCT Center is grateful to the following sponsors of the MRCT Center Bioethics Collaborative:

• Genentech, Inc.
• Eli Lilly & Co.
• Johnson & Johnson
• Merck, known as MSD outside of U.S. and Canada
• Pfizer Inc.
• Sanofi
• Takeda Pharmaceuticals International, Inc.

Recent publications related to meetings of the Bioethics Collaborative can be found here.

Find out more about the Bioethics Collaborative project.

The Research, Development, and Regulatory Roundtable (R3) is an impartial forum to present and discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human participant research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators to identify emerging topics in the clinical research regulatory and legal space, examine the implications to clinical research, and shape the direction of policy and practice.

In 2021, the MRCT Center and Ropes & Gray LLP hosted five meetings of the R3:

• January 2021: Research Misconduct Part 2 Interactions with Journal Editors and Publishers
• March 2021: Research Misconduct Part 3: Interactions with National Regulatory Authorities
• May 2021: 1) Direct Interactions Between Sponsors and Research Participants: A Legal Perspective, and 2) Rethinking the Workforce for Decentralized Clinical Trials: Who is Engaged and Regulatory Requirements
• September 2021: 1) Legal and Regulatory Challenges with Diagnostic Tests in the United States (US), including Laboratory Developed Tests (LDTs), and 2) The Impact of Emerging US State Privacy Laws on Research
• November 2021: 1) The Regulation of Digital Health Tools and Software as a Medical Device, and 2) Update on the Application of the European Union’s General Data Protection Regulation to Research

Publications related to meetings of the R3 are found here.

The MRCT Center and Ropes & Gray LLP are grateful to the following sponsors of the R3:

• Advarra
• Dana-Farber Cancer Institute
• Genentech, Inc.
• International Society for Biological and Environmental Repositories
• Johnson & Johnson
• Merck & Co., Inc.
• Sanofi
• Takeda Pharmaceuticals International, Inc.
• Vertex
• Washington University in St. Louis

Find out more about the Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP project.

In 2022, the MRCT Center’s efforts will continue to advance alignment of policy and practice and to innovate to create solutions that all stakeholders can implement in their work. Our DEI work will focus on education and training, and on creating resources for various stakeholders to advance equity. We will finalize a number of tools to facilitate pediatric research around the globe. Look for the launch of our updated Return of Individual Research Results in early 2022. Training of ethics committee members and chairs across Africa will proceed in collaboration with AVAREF, and we will commence a series of trainings in collaboration with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).

Initiatives on the horizon for 2022 will focus on examining IRB oversight of decentralized clinical trials, updating our previous work related to post-trial access to investigational products and required medical care, and exploring the unique ethical and regulatory issues related to rare diseases, among others.

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