The MRCT Center 2021 Impact Report
IMAGINE. INCLUDE. INSPIRE.
The past year was one of transformation, change, and recognition, from moving clinical research to remote environments, to celebrating the introduction of vaccines and effective therapies for COVID-19, and to understanding the continuing consequences of health inequity. We renewed our appreciation of the importance of communities and of hearing the voices of all participants.
Over the past year, the MRCT Center addressed the pressures and challenges of a changing clinical research eco-system. We continue our work in diversity, inclusion, and equity. Our work focuses not only on inclusion of all participant populations, but also on the training and opportunities of the clinical research workforce. We continue to focus on transparency and accessibility, and advocate for patient-facing materials that are clear and understandable to all. We dedicate effort to capacity building that spans from developing regulatory frameworks for research involving children around the world to virtual and online training of individuals from over 90 countries. And we remain at the forefront of policy development focused on global and state privacy laws related to the use of personal data for health research. And more. This impact report provides the highlights of our year.
Our work requires a multi-disciplined approach. We know that none of this work would be possible without the commitment, trust, and engagement of all of you. We are grateful to our Executive and Steering Committee members, our Senior Advisors, and our External Advisory Board, drawing on their broad experience and expertise. Success of our work is the product of this collaboration, combined with the creativity, skill, and effort of the MRCT Center team. Our inspiration comes from the motivating stories of the adult and adolescent patients/participants that join our initiatives. We thank you all.
Be well in the upcoming year. Take delight in the reopening of the world. We look forward to the new year where we will not only continue to make progress but when we can sit at the table with you.
Sarah White, MPH
Barbara Bierer, MD
Mark Barnes, JD, LLM
MRCT CENTER PROJECT HIGHLIGHTS
The MRCT Center’s multidisciplinary teams collaborate to identify challenges and deliver ethical, actionable, and practical solutions for the global clinical trial enterprise, with a focus on multinational clinical research.
Advancing the Quality of Clinical Trial Enterprise
Improving the quality and reporting of clinical trials
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.
Capacity Building for clinical research and ethics
Delivering ethics and regulatory trainings worldwide
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
Empowering patients, participants, and the public to make informed choices
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.
Diversity, Inclusion, and Equity in Clinical Research
Equity by Design
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.
Return of Individual Research Results
Advancing return of individual research results to meet participants’ needs and expectations
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.
Promoting Global Clinical Research in Children
Working to ensure children are protected in and through clinical research
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.
Examining complex ethical issues in multi-national clinical trials
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.
- 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.
Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP
The front line of legal and regulatory issues in international clinical research
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:
- Dana-Farber Cancer Institute
- Genentech, Inc.
- International Society for Biological and Environmental Repositories
- Johnson & Johnson
- Merck & Co., Inc.
- Takeda Pharmaceuticals International, Inc.
- 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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PUBLICATIONS & PRESENTATIONS
MRCT Center Leadership, Senior Advisors, and team members regularly contribute commentaries and articles to academic journals. The MRCT Center has also hosted several webinars throughout the year. Selected publications and presentations over this past year are available here.
Genomic Epidemiology Data Infrastructure Needs for SARS-CoV-2: Modernizing Pandemic Response Strategies
Committee on Data Needs to Monitor the Evolution of SARS-CoV-2 (Griffin D, …. Zarin, D); Board on Health Sciences Policy; Health and Medicine Division; Board on Life Sciences; Division on Earth and Life Studies; National Academies of Sciences, Engineering, and Medicine. Washington, DC: The National Academies Press, 2020. DOI: 10.17226/25879.
Promoting equity in understanding: A cross-organizational plain language glossary for clinical research
Baedorf Kassis S, Bahador B, Gawrylewski H, Gertel A, Pickard B, White SA, Bierer BE. Medical Writing, 29(4):10-15. December 2020.
Real-World Evidence: Understanding Sources of Variability Through Empirical Analysis
Crown WH, Bierer, BE, Value Health, January 2021, 24(1):116-117. DOI: 10.1016/j.jval.2020.11.003
An Ethics framework for consolidating and prioritizing COVID-19 clinical trials
Meyer MN, Gelinas L, Bierer BE, Hull SC, Joffe S, Magnus D, Mohapatra S, Sharp RR, Spector-Bagdady K, Sugarman S, Wilfond BS, Fernandez Lynch H. Clinical Trials, 18(2):226-233. February 2021. DOI: 10.1177/1740774520988669
A Descriptive-Multivariate Analysis of Community Knowledge, Confidence, and Trust in COVID-19 Clinical Trials among Healthcare Workers in Uganda
Kasozi KI, Laudisoit A, Osuwat LO, Batiha GES, Al Omairi NE, Aigbogun E, Ninsiima HI, Usman IM, DeTora LM, MacLeod ET, Nalugo H, Crawley FP, Bierer BE, et al. Vaccines, 9:253ff. March 2021. DOI:10.3390/vaccines9030253
Health Info Blocking Rule Creates Opportunities For Research
Peloquin D, Moundas C, Palte G. Law360, March 8, 2021. https://www.law360.com/articles/1362501
Justice, diversity, and research ethics review
Strauss DH, White SA, Bierer BE. Science, 371(6535):1209-1211. March 2021.DOI: 10.1126/science.abf2170
Lack of harmonization of coronavirus disease ordinal scales
Zarin DA, Rosenfeld S, Clinical Trials, 18(2):263-264, April 2021. DOI: 10.1177/1740774520972082
Mutual Recognition Of Physician Licensure By States Would Provide For Better Patient Care
Liss JM, Peloquin D, Bierer BE. Health Affairs Blog, May 10, 2021. DOI: 10.1377/hblog20210505.311262
Trial Reporting and the Clinical Trials Enterprise
Zarin DA, Califf RM, JAMA Internal Medicine, 181(8):1131-1132. May 2021. DOI:10.1001/jamainternmed.2021.2041
Fair payment and just benefits to enhance diversity in clinical research
Bierer BE, White SA, Gelinas L, Strauss DH. Journal of Clinical and Translational Science, 5(1):e159. July 2021. DOI:10.1017/cts.2021.816
Online Research Participant Communications: Balancing Benefits and Risks
Gelinas L, Morrell W, White SA, Bierer BE. Ethics and Human Research, 43(4): 2-10. July 2021. DOI:10.1002/eahr.500094
Demystifying Schrems II for the cross-border transfer of clinical research data
Liss J, Peloquin D, Barnes M, Bierer BE. Journal of Law of the Biosciences, 8(2), July-December 2021. DOI: 10.1093/jlb/lsab032
Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov
Muthukumar AV, Morrell W, Bierer BE. PLoS Medicine, 18(9):e1003758. September 2021. DOI:10.1371/journal.pmed.1003758
Monitoring the Pediatric Clinical Trials Enterprise
Califf RM, Zarin DA. Pediatrics, 148 (3): e2021051589. September 2021. DOI: 10.1542/peds.2021-051589
Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings
Shen FX, Wolf SM, Bhavnani S, Deoni S, Elison JT, Fair D, Garwood M, Gee MS, Geethanath S, Kay K, Lim KO, Estrin GL, Luciana M, Peloquin D, Rommelfanger K, Schiess N, Siddiqui K, Torres F, Vaughan JT. NeuroImage, 238, September 2021. DOI:10.1016/j.neuroimage.2021.118210
Navigating the ethics of remote research data collection
Gelinas L, Morrell W, White SA, Bierer BE. Clinical Trials, 18(5):606-614. October 2021.
Integrating Supported Decision-Making into the Clinical Research Process
Bierer BE, Ne’eman A, DeCormier Plosky W, Strauss DH, Silverman BC, Stein MA. The American Journal of Bioethics, 21(11):32-35. October 2021. DOI:10.1080/15265161.2021.1980141
Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use
Seykora A, Coleman C, Rosenfeld SJ, Bierer BE, Lynch HF. Ethics & Human Research, 43(2021):1-17. October 2021. DOI:10.1002/eahr.500106
Testing approaches to sharing trial results with participants: The Show RESPECT cluster randomized, factorial, mixed methods trial
South A, Joharatnam-Hogan N, Purvis C, James EC, Diaz-Montana C, Cragg WJ, Tweed C, Macnair A, Sydes MR, Snowdon C, Gillies K, Isaacs T, Bierer BE, Copas AJ. PLoS Medicine, 18(10):e1003798. October 2021. DOI: 10.1371/journal.pmed.1003798
Characterization of Informed Consent Forms Posted on ClinicalTrials.gov
Tse T, White S, Gelinas L, Morrell W, Bierer B, Zarin D. JAMA Network Open, November 2021. 4(11):e2135146. DOI:10.1001/jamanetworkopen.2021.35146
- January 13: Leaning In: Data Standards and Analysis
- January 27: Leaning In: Stakeholder Roles and Responsibilities
- February 10: Leaning In: Role of Data in Diversity: Genetics and Real World Data
- April 14: Driving Inclusion in Clinical Research: How to Begin
- May 12: Driving Inclusion in Clinical Research: Inducement of Fair Compensation? Impact on Diverse Participation
- June 9: Driving Inclusion in Clinical Research: Improving Inclusion of Persons with Disabilities in Clinical Research
- June 16+24: Reimagining Clinical Trials: Learning from COVID-19 (2-part virtual conference)
- July 14: Driving Inclusion in Clinical Research: Simplifying the Complexity of Translation in Clinical Research
- October 6+7: Advancing International Pediatric Clinical Research: Part One: Informing the Future From COVID-19 Lessons Learned
The MRCT Center engages a diverse group of stakeholders to define our work and develop and implement our solutions. We welcome members of industry, academia, government, non-profit organizations, patient advocacy and patients to collaborate with some or all of our projects. Want to join the effort? Contact us!
Thank you to our External Advisory Board, Executive Committee, and Steering Committee for their continued support. Your contributions ensure that we, collectively and collaboratively, commit to the ethical conduct of clinical trials across the globe. Find out how to become a sponsor.
- Bernard Lo (Chair), Greenwall Foundation
- Joshua Boger, Vertex Founder and former CEO
- Cristina Csimma, Biopharmaceutical Board Director and Independent Consultant
- Jeffrey Drazen, NEJM Group
- Margaret Hamburg, Former FDA Commissioner
- Nina Hill, Independent Consultant and former Vice President at Pfizer
- Guido Rasi, European Medicines Agency Emeritus
- Michael Rosenblatt, Flagship Pioneering
- Ara Tahmassian, Harvard University
- Emeritus, Atul Gawande, USAID
- Alexion Pharmaceuticals
- Amgen, Inc.
- Bill & Melinda Gates Foundation
- Brigham and Women’s Hospital
- Eli Lilly and Co.
- Harvard University
- Johnson and Johnson
- Merck, known as MSD outside of U.S. and Canada
- Microsoft, Life Sciences Innovation
- Ropes and Gray LLP
- Takeda Pharmaceuticals U.S.A., Inc.
- Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)
- Association of Clinical Research Professionals (ACRP)
- Biogen Inc.
- Biotechnology Innovation Organization (BIO)
- Clinical Data Interchange Standards Consortium, Inc. (CDISC)
- Comprehensive and Integrative Medicine Institute (CIMI)
- Daegu Catholic University Medical Center (DCUMC)
- European Clinical Research Infrastructure Network (ECRIN)
- Genentech – a member of the Roche Group
- Indian Society for Clinical Research
- Kowa Research Institute
- PanAmerican Clinical Research
- PRAXIS Australia
- RIKEN, Center for Integrative Medical Sciences
- Target Health Inc.
- WIRB-Copernicus Group