Since the updated Individual Return of Results toolkit was released last year, the MRCT Center has continued collaborating with leaders from academia, patient advocacy groups, and industry to create a series of case studies. These cases detail the experiences of five organizations planning and implementing procedures to return individual research results and data to participants, highlighting ethical, scientific, operational, regulatory, and technical considerations that should be considered.
We invite you to join us on May 2 at 12 PM ET for a moderated conversation with case study authors who will share their experiences, successes, and challenges. To register, please click here.
Accessibility by Design (AbD) Toolkit Release and Webinar: May 4
Globally, over one billion people, including 240 million children, have a disability. In the US alone, more than 61 million people with disabilities make up the largest minority group in the nation. Yet, clinical trials can often exclude them. Therefore, clinical research stakeholders committed to inclusion must act affirmatively and concertedly to anticipate, identify, and accommodate the needs of individuals with disabilities.
To this end, the MRCT Center has developed an Accessibility by Design in Clinical Research Toolkit in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research. We will release the toolkit at a webinar on May 4 at11 AM ET. We will present the background, structure, and key themes of the AbD Toolkit. Invited speakers will then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.
Please note: a webinar recording and transcript will be posted to the MRCT Center website following the webinar. All registrants will receive a follow-up email with a direct link to these materials. We look forward to continuing the dialogue to support inclusivity and accessibility for all.
ICH E6 (R2) Training Modules: Making a Broad Impact
The MRCT Center launched the introductory online course INTERPRETATION AND APPLICATION OF ICH E6 (R2) in early 2020. Since then, approximately 3,500 individuals from more than 100 countries have enrolled, with numbers increasing monthly.
Countries with the highest enrollments are the US, India, Canada, Brazil, and China.
Events & Presentations
April 27
Sarah White, Executive Director of the MRCT Center, presented at CTTI’s April Steering Committee meeting in Washington, DC. Sarah joined colleagues from CTTI, FasterCures, and the National Academies of Sciences, Engineering, and Medicine in a fireside chat that described a collaborative project called Diversity Convergence, a new initiative that the MRCT Center will co-lead.
April 28
Dr. Willyanne DeCormier Plosky, MRCT Center Program Director, presented “Equitable Inclusion of Persons with Disabilities in Research” at the University of Minnesota Ethics Grand Rounds.
May 2: 12 – 1 PM ET
Return of Individual Results Case Studies Release and Webinar (see Spotlight above).
Dr. Barbara Bierer will present “The Evolving Role of Decentralized Clinical Trials” at the inaugural Baptist Health Biomedical Research Symposium in Miami, Florida.
May 16-18
Dr. Barbara Bierer will present “Ethical Review of Decentralized Clinical Trials” at the AAHRPP Annual Conference in Baltimore, MD.
Hayat Ahmed, MRCT Center Project Manager, will present a poster on “Tools & Resources for Incorporating DEI in IRB/HRPP Processes” at the AAHRPP Annual Conference.
Publications
April 4, 2023: Drs. Nora Hutchinson, Luke Gelinas, and Deborah Zarin evaluated a cross-section of interventional clinical trials registered on ClinicalTrials.gov with publicly available informed consent forms; only 56.6% acknowledged the possibility of trial termination. Their study resulted in a coauthored research letter, “Disclosure of Possible Trial Termination to Participants of Interventional Clinical Trials,” published in JAMA.
April 14, 2023: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.
May 2023: MRCT Center Faculty Director Dr. Barbara Bierer co-authored an article, “Data sharing in the context of community-engaged research partnerships,” in Social Science and Medicine in response to a new NIH data-sharing policy. In an era of growing efforts to engage diverse communities in research, the impact of data sharing for all research participants and the communities they represent requires the reassessment of data-sharing principles, incorporating principles of community-engaged research. The article outlines these considerations and proposes new models of benefit sharing.
MRCT Center and CDISC Collaborate to Advance the Plain Language Clinical Research Glossary
We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) to promote the MRCT Center Clinical Research Glossary as a global clinical research standard. The MRCT Center Clinical Research Glossary is a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers. With this collaboration, the MRCT Center Clinical Research Glossary will be offered as a CDISC standard, helping sustain and expand its reach across the research enterprise. It will grow over time, increasingly helpful to participants and in participant-facing clinical research communications. As part of this collaboration, all plain language definitions in the MRCT Center Clinical Research Glossary will undergo CDISC’s public review process, which is now open through April 14.
Click here for a helpful video tutorial on how to submit comments.
Please join us on April 5 from 11 AM – 12 PM ET for a joint MRCT Center and CDISC webinar. Learn about MRCT Center’s robust process of developing the plain language glossary, CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.
Release ofIncluding Young People in Research toolkit
This toolkit is offered to assist investigators, sponsors, IRBs, and others in their support of the inclusion of young people as patient partners in clinical research and research-related activities. Only by inviting young people to the table will we help ensure that their perspectives are heard and valued.
Click here to view the Including Young People in Research toolkit, the “how-to” companion video, and related resources.
JTF Framework
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Bahasa Indonesia. Click here to view.
Terjemahan Bahasa Indonesia dari Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework kini tersedia!
Kami dengan senang hati mengumumkan bahwa Satuan Tugas Gabungan untuk Kompetensi Uji Coba Klinis (JTF) Kerangka Kerja Kompetensi Inti untuk Profesional Riset Klinis kini tersedia dalam Bahasa Indonesia. Klik di sini untuk melihat.
Pediatrics Webinar – Promoting Global Clinical Research in Children: Informing the Future
Headlands Research is an international integrated network of clinical trial sites with a focus on diversity, quality, and cutting-edge technology. Learn more about Headlands Research here.
Medable is the decentralized clinical trial platform with the most global experience. Learn more about Medable here.
MRCT Center Faculty Director Dr. Barbara Bierer presented “Diversity, inclusion, and equity in clinical trials: The role of OBGYNs in ensuring diverse representation” at the American College of Osteopathic Obstetricians and Gynecologists (ACOOG).
March 30
MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky spoke on “Action and Accountability: Equity by Design” at the NIH Workshop on Inclusive Participation in Clinical Research.
April 5: 11 AM – 12 PM ET
“Announcing a Global Standard in Plain Language for Clinical Research: A Joint Webinar by the MRCT Center and CDISC.” (See Spotlight above.)
Sylvia Baedorf Kassis, MPH, will present on the MRCT Center’s Clinical Research Glossary at the Network of the National Library of Medicine’s “Health Misinformation Symposium: Explore the History, Research, and Solutions.”
Bioethics Collaborative (BC): Trials and Tribulations of N of 1 Trials (open to BC Sponsors and select guests)
N-of-1 trials share a common feature: trials are single-subject clinical trial designs with the goal of determining how an individual patient responds to treatment intervention(s), often involving a “pre-post” design. These trials can take a number of forms, spanning different purposes and applications, advantages, and challenges. The discussion will focus on the ethical and regulatory issues attendant with these trials.
April 18: 2:00 PM ET
Barbara Bierer will be presenting with Jamie Tyrone, patient advocate, and Sarah Walter, Alzheimer’s Clinical Trial Consortium, on “Sharing Individual Research Results in Decentralized Studies: A Participant’s Perspective, a Toolkit, and Case Study in Alzheimer’s Disease,” at #DCT2023, the Decentralized Clinical Trials conference in Boston, MA.
MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky will present, “Equitable of People with Disabilities in Clinical Research” at the Ethics Grand Rounds at the Center for Bioethics at the University of Minnesota.
Returning Individual Research Results and Data to Participants: Experience from the Field
The MRCT Center is pleased to release a set of four case study experiences: from planning and implementing tools and procedures to returning individual results and data to research participants. Join us for a moderated discussion with stakeholders as they share lessons learned and strategies for the future.
Accessibility by Design (AbD) in Clinical Research Toolkit Webinar
Commitment to greater inclusion of people with disabilities in clinical trials requires identifying the barriers to participation, study planning, and execution.
Please join us on May 4th, 2023, 11:00 am – 12:00 pm ET as we launch the Accessibility by Design (AbD) in Clinical Research Toolkit, aproduct developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.
March 29, 2023: Dr. Barbara Bierer and Laura Meloney collaborated with Ariel Carmeli, a graduate student at Harvard Medical School Department of Biomedical Informatics and Harvard Business School, to develop a dynamic data visualization tool. The tool allows users to explore demographic representation in clinical trials associated with 339 FDA drug and biologic approvals from 2015-2021, using data from FDA Drug Trials Snapshots. The tool can help organizations improve trial representation and enhance health equity by providing information on trial representation over time, according to race, ethnicity, age, and sex, across therapeutic areas and pharmaceutical sponsors.
Dr. Barbara Bierer joined the Board at Generation Patient, a non-profit organization dedicated to advocacy initiatives for young adults living with chronic and rare conditions to ensure that they have the opportunities and resources to thrive. She said, “The opportunity to engage with an organization dedicated to and led by young people living with chronic conditions, and involved in care and clinical research, was compelling. Too often, the medical enterprise talks about patients, but not with patients. We must elevate the voices and perspectives of those with the lived experience to support one another and to inform our collective future efforts.”
The MRCT Center is delighted to announce our upcoming webinar,“Promoting Global Clinical Research in Children: Informing the Future,” the fifth and final part of the FDA-supported virtual conference series on FDA-supported virtual conference series on Advancing International Pediatric Clinical Research. This event will showcase select resources and materials developed by the MRCT Center pediatric working group initiative, including highlights from the four prior webinars in this series.
For more information about the MRCT Center’s work to promote global clinical research in children, click here.
Annual Meeting Proceedings and Slides
Proceedings and slides have been posted from the MRCT Center Annual Meeting in December 2022. The meeting included a fireside chat with Dr. Kenneth Frazier, retired Chairman and CEO of Merck, and panel discussions on expanding the footprint of clinical trials as well as the ethical and regulatory basis for secondary research uses of biospecimens.
March 2: 1 PM – 3:30 PM ESTResearch, Development, & Regulatory Roundtable (R3): open to R3 Sponsors
The first topic will be presented by Ropes & Gray LLP partner Kellie Combs, who practices in the firm’s Life Science Regulatory and Compliance practice group and is a co-lead of the firm’s cross-practice digital health initiative.She will provide an overview of FDA’s 2022 final guidance on clinical decision support (“CDS”) software. Algorithms used in clinical trials may be regulated as CDS, and the CDS framework also has a complex overlay with the laboratory-developed test (“LDT”) framework that has been discussed at past R3 meetings.
The second topic, presented by Ropes & Gray partner and MRCT Center Senior Advisor David Peloquin, will address sections of Food and Drug Omnibus Reform Act of 2022 (“FDORA”) that are relevant to clinical researchers. This includes requirements for certain clinical trial sponsors to file diversity action plans, provisions intended to clarify and advance the use of decentralized clinical studies, provisions intended to clarify the use of digital health technologies in clinical trials, and recommendations on the use of other innovative trial designs.
To learn more about the Research, Development, & Regulatory Roundtable (R3), click here.
March 3: 12:30 PM – 3:30 PM Japan/11:30-2:30 Singapore
Virtual Asia Pacific Open Forum
Join MRCT Faculty Co-Director Mark Barnes and the Science Policy Think Tank for an open forum and virtual discussion about the international governance of sharing of and access to biospecimens and associated data. The forum is timed for an Asia-Pacific audience. Spread the word!
March 30: 12:30 – 1:40 PM EDT “Study Design and Site Selection: MRCT Diversity Guidance Toolkit”
MRCT Center Acting Program Director Dr. Willyanne DeCormier Plosky will speak on “Study Design and Site Selection: MRCT Diversity Guidance Toolkit” at the NIH Workshop on Inclusive Participation in Clinical Research.
Click here for more information about the workshop and to register.
To download and learn more about the MRCT Center’s “Achieving Diversity, Inclusion, and Equity In Clinical Research” toolkit,click here.
Update from the Brocher Conference in January
Photo: Lauren Otterman, Elisa Koppelman, Dr. Barbara Bierer, and Dr. Nora Hutchinson
We are delighted to share that the conference, “Aligning Stakeholders to Facilitate Pediatric Access to Medicines: From Product Development through HTA Review,” held at the Fondation Brocher in Hermance, Switzerland was a great success! 26 representatives from academia, industry, patients and patient advocacy groups, regulators, and bioethicists from Europe, the UK, Canada, and the US convened for two intensive days of discussion to address existing barriers and potential opportunities to improve the efficiency of pediatric drug development and access to medicines. A summary of the meeting and proposed next steps to advance this work will be forthcoming.
Publications
January 28, 2023: Elisa Koppelman, Dr. Barbara Bierer, Dr. Steven Joffe and others co-authored an article, “Establishing a global regulatory floor for children’s decisions about participation in clinical research” that offered recommendations to clarify the International Council for Harmonization ICH-E11 guidelines, recommendations that would serve to promote a common ethical platform for conducting global pediatric research in Pediatric Research.
We welcome new Executive and Steering Committee sponsors! Gilead joined the Executive Committee in late 2022. Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. Learn more about Gilead here.
Two organizations have joined the Steering Committee: PPD, part of Thermo Fisher Scientific, clinical development and analytical services enable customers to accelerate innovation and increase drug development productivity. Learn more about PPD here.
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. Learn more about Syneos Heath here. Learn more about MRCT Center sponsors.
We are delighted to present the MRCT Center Impact Report 2022. This web-based, interactive resource includes our current projects and recent guidance. Thank you for your continued support as we work collectively to promote global clinical trials.
Advancing International Clinical Research Webinar Series
The fifth and final conference in the FDA-supported webinar series, “Promoting Global Clinical Research in Children: Informing the Future,” is scheduled for March 21, 2023, from 9:00 AM – 11:00 AM EDT. This event will showcase select resources and materials from the larger body of work created, and the four webinars held, throughout the work of the MRCT Center pediatric working group initiative.
We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Thai.
The JTF held a global strategic meeting in November 2022 that included international JTF activity updates and an introduction to two new initiatives: (1) a Data Management and Informatics Task Force and (2) efforts to establish validated assessments of clinical research competencies.
Click here for the Executive Summaries and Conference Slides. If you are interested in contributing to the new initiatives, please contact Carmen Aldinger.
New Chinese Modules released for ICH Efficacy Guidelines
Three years ago, the MRCT Center created an online training course entitled, “Interpretation and Application of ICH E6(R2).” Recently, PATH translated several modules into Chinese. These modules are now available.
The MRCT Center is delighted to announce that Dr. Barbara Bierer, MRCT Center Faculty Director, and several team members–Dr. Nora Hutchinson, Lisa Koppelman, and Lauren Otterman–are currently in Switzerland to host a 2-day conference, “Aligning Stakeholders to Facilitate Pediatric Access to Medicines: From Product Development through HTA Review,” held at theFondation Brocher. Supported in part by an award from the Fondation, 26 representatives of academia, industry, patients and patient advocacy groups, regulators, bioethicists, and statisticians from Europe, the UK, the US, and Canada will address existing barriers and potential opportunities to improve the efficiency of pediatric drug development and access to medicines.
On January 30 and January 31, 2023, Dr. Bierer is co-chairing the National Academies of Sciences, Engineering, and Medicine’s Committee on Science, Technology, and Law virtual workshop: “The Food and Drug Administration’s Accelerated Approval Process for New Pharmaceuticals.” The event is free and open to the public. For more information and to register, click here.
Dr. Willyanne DeCormier Plosky will present at the BIO’sClinical Trial Diversity Roundtable on January 31. The session’s title is “Analyzing the Data We Have Today, Enhancing Data Sources and Infrastructure for the Future, and Building a Diverse Workforce.”
PUBLICATIONS
January 4, 2023: Members of the MRCT Center, including Senior Advisor Dr. Luke Gelinas, and Drs. Deborah Zarin and Barbara Bierer, published an empirical study, “Ensuring the Scientific Value and Feasibility of Clinical Trials: A Qualitative Interview Study,” to elucidate current practice and identify areas of need concerning the scientific value and feasibility of planned and ongoing clinical trials in the American Journal of Bioethics (AJOB) Empirical Bioethics. Learn More.
December 20, 2022: Dr. Barbara Bierer submitted comments on behalf of the MRCT Center to the FDA regarding “Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Guidance for Industry, Sponsors, and IRBs. Learn More.
December 7, 2022: MRCT Center Senior Advisors Drs. Luke Gelinas and David Strauss, with Dr. Barbara Bierer, co-authored an article on “Protecting the Vulnerable And Including the Under-Represented: IRB Practices and Attitudes” published in the Journal of Empirical Research on Human Research Ethics. It examines the role of IRBs in ensuring representativeness in clinical research while protecting vulnerable populations. Learn More.
October 2022: MRCT Center’s Dr. Bierer and Sylvia Baedorf Kassis co-authored an article entitled “Acupuncture for hot flashes in hormone receptor-positive breast cancer, a coordinated multinational study: Rationale and design of the study protocol,” which was published in Contemporary Clinical Trials. The article presents the details of a randomized acupuncture intervention protocol conducted in the US, South Korea, and China. Learn More.
Sponsor News and Events
Bioethics Collaborative: Next Meeting – February 2, 2023
The Bioethics Collaborative is a forum to propose, share, and discuss ethical challenges in multi-national clinical trials.
The next meeting on February 2,2023, will explore ethical obligations to plan for emergencies, including wars, natural disasters, and public health crises, in advance. Experts from industry and academia will share their perspectives, leaning on firsthand experience. The ethics of emergency preparedness in clinical research is an under-explored topic, and we look forward to a lively discussion. A meeting summary will be made available to Sponsors through the Bioethics Collaborative page on our website.
Research, Development, and Regulatory Roundtable (R3): Next Meeting – March 2, 2023
Initiated in 2018 with our partners Ropes & Gray LLP, theResearch, Development, and Regulatory Roundtable (R3) fosters discussion among policymakers, legal counsels, academicians, industry representatives, and global regulators.
The next meeting on March 2, 2023, “FDA’s Clinical Decision Support Software Final Guidance & Clinical Trial-Related Provisions of the Food and Drug Omnibus Reform Act of 2022,” will cover two topics: (1) an overview of the FDA’s recent final guidance on clinical decision support (“CDS”) software, with a focus on its application to clinical research settings, and (2) the provisions of the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) related to advancing diversity, equity, and inclusion in clinical trial enrollment and promoting clinical trial modernization.
The most recent meeting on December 13, 2022, revisited the impact of international privacy laws on research, including recent changes in the European Union’s General Data Protection Regulation (“GDPR”). The meeting consisted of a series of expert panels that addressed challenges to research presented by data privacy regulations under the GDPR and other geographies, such as the Personal Information Protection Law of the People’s Republic of China (“PIPL”). Francis Collins, M.D., Ph.D., Special Advisor to President Biden for Special Projects and former director of the National Institutes of Health, delivered a keynote address to the over 100 guests in attendance across the globe.
Samjhana is focusing on capacity-building and training related to the design and conduct of clinical trials for a global audience, as well as leading a project assessing and resolving common barriers in clinical trials.
The MRCT Center Annual Meeting is scheduled for Wednesday, December 14, 2022, 8:00 AM – 1:00 PM ET at Ropes & Gray, Prudential Center, Boston, and is open to the public.
Additional resources for Institutional Review Boards (IRBs) and Human Research Protection Programs (HRPPs) to address diversity, equity and inclusion in their work have been released:
For more information about the IRB and HRPP Toolkit, click here.
Clinical Trial Optimization in Kenya and Nigeria
In collaboration with AVAREF and WHO, Dr. Barbara Bierer, MRCT Center Faculty Director, recently traveled to Kenya and Nigeria to learn about the current challenges in clinical trial application review and approval processes in the two countries, including the identification of root causes of delay, and to help develop mitigation strategies. WHO also piloted the use of an ethics bench marking tool created by a WHO committee on which Dr. Bierer served in 2021.
left to right: Carl Coleman: Professor of Law, Seton Hall Law School; Barbara Bierer, MD: Faculty Director, MRCT Center and Professor, Harvard Medical School; Moji Christianah Adeyeye, PhD, FAS: Director-General, NAFDAC; Diadié Maïga, PharmD, PhD: Technical Officer, Vaccine Regulation, UCN/Vaccine Preventable Diseases: WHO – Regional Office for Africa; Alambo Mssusa: Consultant for Regulation and Safety, UCN/Vaccine Preventable Diseases: WHO – Regional Office for Africa
Office of the Director-General, Lagos, Nigeria
Virtual Training for Biotechnology Lecturers in Indonesia
In October 2022, as part of 2022 Association of Indonesia’s Biotechnology Study (IPSBI) Programs, the MRCT Center delivered virtual training to provide advanced learning for public and private university lecturers who teach in undergraduate and graduate biotechnology degree programs in Indonesia. The training focused on real world data, genomics, and research ethics to capacitate and advance the field of biotechnology at the university and graduate level.
October 6, 2022 : Dr. Bierer spoke with Boston 25 about the MRCT Center’s recent study showing that clinical trial eligibility criteria frequently excluded people with disabilities.
October 31, 2022: The Office of Research Integrity (ORI) put out a request for information and comments (RFI) related to the 2005 PHS Policies on Research Misconduct (42 C.F.R. Parts 50 and 93). Comments were submitted on behalf of Ropes & Gray and the MRCT Center as well as a number of collaborating institutions. Learn More.
October 21, 2022: Drs. Bierer and DeCormier Plosky co-authored an article led by Benjamin C. Silverman (MGB) entitled “Supported decision-making can advance clinical research participation for people with disabilities,” published in Nature Medicine. Learn More.
October 3, 2022: Willyanne DeCormier Plosky, Program Manager at the MRCT Center, and Dr. Bierer, with others, co-authored “Excluding People With Disabilities From Clinical Research: Eligibility Criteria Lack Clarity And Justification,” published in Health Affairs, available for free (open access). Learn More.
October 2, 2022: The MRCT Center provided public comments to the U.S. Department of Health and Human Services, Office for Civil Rights about “Docket No. RIN 0945-AA17, Nondiscrimination in Health Programs and Activities Proposed Rule Section 1557 of the Affordable Care Act.” Learn More.
September 29, 2022: To explore the operational and statistical complexities of analyzing pooled individual patient data (IPD), Dr. Bierer and colleagues performed a meta-analysis that reinforced that hydroxychloroquine/chloroquine is not efficacious for treatment of COVID-19 in hospitalized patients, published as “Hydroxychloroquine/chloroquine for the treatment of hospitalized patients with COVID-19: An individual participant data meta-analysis” in PLoS One. Learn More.
September 28, 2022: In an Open Peer Commentary, “Externalist, Process-Based Approach to Supported Decision-Makin,” published in the American Journal of Bioethics, Dr. Bierer and collaborators Leslie Francis and Michael Stein defended a process-based approach in which people with cognitive disabilities choose supporters to facilitate their making or communicating decisions. Learn More.
MRCT Center Updates
The MRCT Center welcomes:
Nannie Clough, Senior Communications and Web Specialist. Katharine Wright, a freelance consultant working with MRCT colleagues on the global diversity initiative, as part of the Center’s DEI portfolio.
Dr. Bierer was welcomed to the Executive Committee of the Clinical Trials Transformation Initiative (CTTI). Learn more.
The MRCT Center Annual Meeting is scheduled for Wednesday, December 14, 2022, 8:00 AM – 1:00 PM at Ropes & Gray, Prudential Center, Boston, and is open to the public. Remote participation will be possible (but not preferred).
We are delighted to announce the release of three new pediatric educational brochures in the series about clinical research topics. Developed by high school and college students, written for 12- to 17-year-olds, reviewed by international youth advisory networks, and proudly bearing the the International Children’s Advisory Network (iCAN) Seal of Approval.
SENSITIVE INFORMATION IN RESEARCH This brochure explains why researchers might ask you questions about sensitive topics and how they protect your privacy.
Facilitating Pediatric Medicines Development: Models of Global Cooperation
The fourth conference in the series, “Facilitating Pediatric Medicines Development: Models of Global Cooperation,” focuses on global regulatory cooperation with an eye to building on existing models to strengthen the global regulatory ecosystem for pediatric drug approval. This two-part webinar will take place on 29 November 2022 at 9 –11:30 am ET and 30 November 2022 at 9 –11 am ET. We encourage you to attend both parts of this virtual meeting as the second part builds on part one. Please register here.
Virtual DSMC Training in the Philippines
In July, 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.
PRESENTATIONS
August 23, 2022: MRCT Center Faculty Director, Dr. Barbara Bierer, presented “Not net neutral: data science, technology, ethics, and social impact” at PhUSE—the Global Healthcare Data Science Community.
PUBLICATIONS
August 2, 2022: MRCT Center Program Director, Sylvia Baedorf Kassis, contributed a blog post to Amp&rsand, The PRIM&R Blog: “Integrate Health Literacy Training into Your IRB’s Onboarding and Professional Development Activities”Learn More. August 13, 2022: Barbara Bierer co-authored “Can Observational Analyses of Routinely Collected Data Emulate Randomized Trials? Design and Feasibility of the Observational Patient Evidence for Regulatory Approval Science and Understanding Disease Project” published in Value in Health. This article is available, free of charge, until October 2, 2022. Learn More.
August 17, 2022: Sarah White, MRCT Center Executive Director contributed to the ACRP blog post related to “Tackling Diversity in Clinical Trials May Require Wider ‘Aperture’’’ Learn More. August 17, 2022: MRCT Center Program Director, Dr. Deborah Zarin, and MRCT Center Postdoctoral Research Fellow, Dr. Nora Hutchinson, co-authored the article “The proportion of randomized controlled trials that inform clinical practice,” published in eLife. Learn More. August 22, 2022: The MRCT Center provided public comments to the Ministry of Health and Family Welfare, New Delhi, India on their Draft of New Drugs, Medical Devices and Cosmetics Bill. Learn More. – This is available to MRCT Center sponsors only for the next six months. Interested in becoming an MRCT Center sponsor? Learn More.
Join Willyanne DeCormier Plosky, Program Manager at the MRCT Center, and Health Affairs on Monday, October 3, 2022, at 1:00 pm ET for a free Virtual Symposium on Disability & Health. Register now
Also, watch for the October 3rd release of Health Affairs, in which Drs. DeCormier Plosky and Bierer from the MRCT Center and colleagues from Harvard, Mass General Brigham, University of Utah, and Columbia will publish an empirical paper on study protocol eligibility criteria that may lead to language to the inappropriate exclusion of people with disabilities from clinical trials.
RECORDINGS AND RESOURCES FROM MRCT CENTER WEBINARS
Equity by Design in Clinical Research: The EbD Metrics Framework
The MRCT Center launched Equity by Design in Clinical Research: The EbD Metrics Framework, a tool that outlines 7 domains of strategic and tactical considerations to advance DEI in clinical research. Intentionally high-level, the framework can be adapted to the work of all organizations. Speakers discussed how their organizations have used the Framework to complement their own work and to stimulate action. Watch the webinar HERE. Access the Framework HERE.
Equity by Design in Clinical Research: A Six-Part Course
This MRCT Center course is now publicly available and provides training to advance diversity, equity, and inclusion (DEI) of underrepresented populations in clinical trials. Ethical and regulatory considerations are included, and practical guidance for commitment, communication, partnership, and conduct is emphasized. This course was originally conducted as a live virtual course (titled Equity by Design in Clinical Research: Cancer Trials). It has been reformatted to be accessible continuously online (not for credit). While some examples in the course are cancer-specific, the course content is broadly applicable to all health areas. Each of the six modules contains a 45-minute recorded instructional session and a 45-minute recorded discussion session with leaders in the field. ENROLL NOW.
Supporting IRB Efforts to Advance Diversity and Inclusion in Clinical Research Tools and Resources
This webinar introduced tools and resources created for IRBs and human participant research programs to help drive DEI in clinical research. Watch the launch webinar HERE. Access resources HERE.
MRCT Center Online Health Literacy Training for IRB Members and Staff
The MRCT Center launched a new online Health Literacy training for IRB members and staff. Designed as a self-paced virtual learning opportunity, IRB members and staff learn to apply health literacy principles to the IRB role. The training includes a facilitation guide to support implementation. Watch the launch webinar HERE. Find the training resources HERE.
Advancing International Pediatric Clinical Research Assent and Consent in the field: Culture Context, and Respect
The third of the 5-part virtual conference series to advance global pediatric clinical trials, entitled “Assent and consent in the field: culture, context, and respect,” focused on the cultural context of assent, consent and the challenges and solutions encountered on the ground. Recordings and slides are available HERE
Using Social Media During a Research Study: How to Connect with Others Safely and Successfully
Intended for research participants, Jamie Tyrone, a dedicated patient and advocate, explains the benefits and risks of using social media in research. The video, a product of the MRCT Center Bioethics Collaborative and publication, was developed to help participants use social media knowledgeably. Access video HERE.
JTF Framework Available in French
In collaboration with F-CRIN (French Clinical Research Infrastructure Network) and several other partners, we are pleased to offer the Joint Task Force for Clinical Trial Competency (JTF) Framework in French. This framework defines the knowledge, skills, and attitudes necessary for conducting safe, ethical, and high-quality clinical research and has been used around the world. Access the Framework HERE.
PRESENTATIONS
May 26, 2022: MRCT Center Executive Director, Sarah White, MPH, joined a plenary session entitled “Mandatory vs. Mission Creep? The Role of DEI in IRBs and HRPPs” at the 2022 AAHRPP Annual Conference in Denver, CO.
June 14, 2022: MRCT Center Program Manager, Willyanne DeCormier Plosky, Ph.D., participated in two plenary sessions at the BIO 2022 International Convention in San Diego, CA: “Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity” MORE “Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research” MORE
June 28, 2022: MRCT Center Faculty Director, Dr. Barbara E. Bierer, presented “Optimizing Targeted Clinical Trial Recruitment and Increasing Diversity, Equity & Inclusion: Leveraging Data Analytics and Collaboration,” a webinar organized by Ropes & Gray and Mass Insight.
July 14, 2022: Dr. Barbara E. Bierer presented “Equitable Engagement and Practices for Children’s Vision Research” in a session at the “The Forum on Children’s Vision: Vision Health and Quality of Life” at Prevent Blindness Focus on Eye Health National Summit. MORE.
PUBLICATIONS
March 2022: MRCT Center Program Director Deborah A. Zarin, together with Harry P. Selker, authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy, or research decisions in a timely manner. MORE
April 2022: MRCT Center Senior Advisors, Luke Gelinas and David Strauss, together with Dr. Barbara E. Bierer, and others authored, “IRBs and the Protection-Inclusion Dilemma: Finding a Balance,” published in The American Journal of Bioethics. The authors address the tension that Institutional Review Boards (IRBs) face “in aiming to both protect potential research participants from harm and include under-represented populations in research” and offer recommendations to support IRB decision-making. MORE
May 2022: Barbara E. Bierer, Sarah White, MRCT Center Senior Administrative and Training Manager, Carmen Aldinger, and MRCT Center consultant Stephen Sonstein co-authored “Self-assessed Competencies of Clinical Research Professional and Recommendations for Further Education and Training,” published in Therapeutic Innovation & Regulatory Science. A global survey of clinical research professionals asked to self-assess their level of competency for each of the 8 domains of the Joint Task Force for Clinical Trial Competency (JTF) Framework, showed that irrespective of role, years of experience, or educational level, lower levels of competency were expressed in the domains of Scientific Concepts and Research Design and Investigational Product Development and Regulation. MORE
May 2022: MRCT Center Project Manager Walker Morrell, Barbara E. Bierer, and colleagues co-authored “When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research” in Ethics & Human Research. Digital applications (apps) used in research may be updated while the research is ongoing, potentially necessitating ethics review. The authors argue that the review process should depend on the nature of the change, any potential change in risk or benefit, and consideration of confidentiality and safety. MORE
May 2022: The MRCT Center submitted public comments to the U.S. Food and Drug Administration in regard to “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials.” MORE
June 2022: Barbara E. Bierer and MRCT Center Program Director Laura G. Meloney co-authored “Strategies to optimize inclusion of women in multi-national clinical trials,” published in Contemporary Clinical Trials. The authors note the persistent complexities in the representation of women in clinical trials, particularly in some therapeutic areas and in certain countries. The article includes approaches and suggestions to address the problem. MORE
June 2022: Deborah A. Zarin co-authored “Approach for reporting master protocol study designs on ClinicalTrials.gov: qualitative analysis,” published in BMJ. The authors describe an approach for reporting master protocol research programs that is consistent with existing good reporting practices and that uses structured information to convey the overall master protocol and design of each substudy. MORE
June 2022: MRCT Center Program Director Sylvia Baedorf Kassis, together with Sarah White, Barbara E. Bierer, and others co-authored “Developing and implementing a self-monitoring toolkit for a coordinated multinational randomized acupuncture trial,” published in BMC Complementary Medicine and Therapies, which describes a self-monitoring toolkit that was developed and implemented in a coordinated multinational trial that involved sites in China, South Korea, and the U.S. Authors conclude that such a tool “provides a feasible, consistent, and effective way to review the collection and maintenance of data and regulatory documentation for quality assessment in minimal risk clinical research studies and can augment formal study monitoring activities.” MORE
WELCOME TO THE MRCT CENTER
Four new Project Managers joined the MRCT Center in June 2022:
Sarah Evenson manages the Bioethics Collaborative and the Research, Development, and Regulatory Roundtable (R3) forums, organizing and preparing content for the meetings as well as leading projects on the ideas that arise during discussion. Sarah graduated from Haverford College in 2021 with a BA in Sociology and completed a Master of Bioethics at the University of Pennsylvania Perelman School of Medicine in 2022. She has previously been an intern in the Biomedical Ethics Research Program at Mayo Clinic and served as a research assistant in a neurobiology lab and on a project investigating the ethics of machine learning applications in precision medicine.
Lauren Otterman is primarily involved in the Center’s work on Promoting Global Clinical research in Children and Return of Aggregate Study Results to participants. Lauren has a background in the Boston non-profit sector, where she worked in various programmatic and operational roles at My Life My Choice and Social Venture Partners Boston. Lauren obtained her Master of Bioethics and Health Law degree from the University of Otago in Dunedin, New Zealand. Her dissertation focused on the ethical, legal, and social impacts of emerging reproductive technologies, specifically artificial womb technologies.
Juliette Pluviose-Philip is primarily involved in the Diversity, Inclusion and Equity in Clinical Research project. Prior to joining the MRCT Center team, Juliette worked with the Boston Public Health Commission’s Neighborhood Trauma Network Team on program evaluation projects. Juliette also has experience as a Research Assistant in the Clinical Laboratory of Occupational Therapy and Health Equity at Boston University’s Sargent College, where she worked on decreasing racial maternal mortality disparities, program evaluation, and health literacy. Juliette obtained her Master of Public Health Degree in Community Assessment, Program Design, Intervention, and Evaluation with a concentration in Maternal and Child Health from the Boston University School of Public Health.
Kayleigh To is currently focusing on projects in Health Literacy in Clinical Research and Post-Trial Responsibilities and Continued Access to Investigational Medicines. Prior to joining the MRCT Center, Kayleigh worked as a research assistant at Brigham and Women’s Hospital researching cardiology and preventative medicine in the Division of Preventive Medicine. She also interned at the Usher Syndrome Coalition where she created tools for governmental advocacy and produced accessible materials summarizing Usher syndrome-related news for the community. Kayleigh graduated from Boston University with a Master’s in Public Health concentrating in Health Policy and Law.
Supporting IRBs: Two Webinars to Introduce Health Literacy, Diversity and Inclusion Resources
MRCT Center Online Health Literacy Training for IRB Members and Staff
June 14, 2022
The IRB can play an important role in championing the creation of research materials for participants that are clear and understandable. Please join us as we launch a new online Health Literacy training for IRB members and staff. The webinar launch will review health literacy concepts and introduce the online training which is designed to be a self-paced opportunity to learn and apply health literacy principles to the IRB role. The training also offers a facilitation guide to support continued conversations with colleagues about how to implement lessons learned. REGISTER NOW
Supporting IRB Efforts to Advance Diversity and Inclusion in Clinical Research Tools and Resources
June 23, 2022
Do IRBs play a role in addressing the problem of diversity, inclusion, and equity (DEI) in clinical research? While IRBs are not the primary driver for assuring DEI in clinical research, IRBs can and should review research for the principles of DEI. This webinar will introduce resources created for IRBs and HRPPs to help drive change. REGISTER NOW
Part 3: Advancing International Pediatric Clinical Research Assent and Consent in the Field: Culture Context, and Respect
June 28, 2022 and June 29, 2022
The MRCT Center is pleased to announce the third of the 5 part virtual conference series to advance global pediatric clinical trials. Entitled “Assent and consent in the field: culture, context, and respect,” the conference will focus on the cultural context of assent and the challenges and solutions encountered on the ground. The 2-hour agenda will feature a moderated panel of experts who will share their experiences with assent around the world, including how to manage the tension between an (ideal) ethical framework and cultural context.
Equity by Design in Clinical Research: The EbD Metrics Framework
June 30, 2022
How can clinical research stakeholders measure progress on diversity, equity, and inclusion (DEI) in clinical research? Please join us as we launch Equity by Design in Clinical Research: The EbD Metrics Framework, a tool developed by the MRCT Center in collaboration with colleagues from professional, trade, academic, regulatory, and patient advocacy organizations. We will first present the background, evolution, and structure of the Framework. Speakers will then discuss how their organizations have considered the Framework to complement their own work and to stimulate further action. REGISTER NOW
MRCT Center launches Return of Individual Research Results project and website
The MRCT Center Webinar for the Return of Individual Research Results (IRR) Project Launch was held on March 24, 2022. Thank you to our MRCT Center speakers: Dr. Barbara Bierer, Faculty Director, and Lisa Murray, Project Manager. A special thank you to our guest speaker, Jamie Tyrone, Patient Advocate, for sharing her story and highlighting the importance of this initiative.The webinar recording and slides are available on the IRR project website.
Advancing International Pediatric Clinical Research Part Three
The MRCT Center is pleased to announce the third of the 5-part virtual conference series to advance global pediatric clinical trials. Entitled “Assent and consent in the field: culture, context, and respect,” the conference will focus on the cultural context of assent and the challenges and solutions encountered on the ground. A panel of global experts will share their experiences with assent, including how to manage the tension between an (ideal) ethical framework and cultural context.
The two-hour webinar will be hosted twice: Tuesday 28 June 2022 at 9-11 am EDT and Wednesday 29 June 2022 at 8-10 pm EDT with similar content but different speakers and panelists, to allow for wide attendance and global participation.
MRCT Center Pediatric Brochures for Youth
We are delighted to announce the release of 3 new pediatric educational brochures in the series about clinical research topics. Developed by high school and college students, written for 12- to 17-year-olds, reviewed by international youth advisory networks, and proudly bearing the International Children’s Advisory Network (iCAN) Seal of Approval. Translations to other languages and additional brochures are forthcoming.
What is Clinical Research? which defines clinical research and the difference between research and medical care.
What is Assent? which defines assent and what young people should consider before providing research assent.
What Happens at the End of a Research Study? which defines clinical research and the difference between research and medical care.
Equity by Design in Clinical Research: Cancer Trials virtual training series recap
The MRCT Center hosted, in partnership with the Center for Cancer Equity and Engagement, Dana-Farber/Harvard Cancer Center, a six-part training series entitled “Equity by Design in Clinical Research: Cancer Trials.” Each module consisted of a 45-minute video lecture and 45 minutes of an interactive discussion session with experts in the field. Over 450 people were registered. All course registrants have until May 13 to finish viewing recordings and to complete their evaluation forms for credit. After May 13, all course materials will be made publicly available on the MRCT Center website (not for CME credit). More
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.
Case-based learnings and breakout room discussions were integrated into course lectures to create a stimulating and engaging virtual learning environment. The MRCT Center looks forward to continuing its partnership with AVAREF to build regulatory capacity across Africa.
March 31, 2022: Research! America hosted an Alliance Discussion with MRCT Center Faculty Director, Barbara E. Bierer, about why IRR requires a policy framework that respects patient rights and promotes transparency in a responsible and efficient manner (and what challenges may be ahead). View webinar
April 28, 2022:Dr. Barbara Bierer was a panelist discussing “Diversity, Inclusion, and Equity in Clinical Trials – a moral and ethical imperative” at the Clinical Trials Platform for a Talking Trials Webinar hosted by South Australian Health and Medical Research Institute.
PUBLICATIONS
March 1, 2022: MRCT Center Program Director Deborah A. Zarin, MD, and Harry P. Selker, MD, MSP authored “Reporting of Clinical Trial Results: Aligning Incentives and Requirements to Do the Right Thing” in Clinical Therapeutics. The authors argue that FDAAA and other trial reporting policies should be systematically and comprehensively enforced, in order to ensure that results from all clinical trials become available to inform clinical, policy or research decisions in a timely manner. Read more
March 4, 2022: Joseph Liss, former Legal Fellow at the MRCT Center, David Peloquin, Mark Barnes and Barbara Bierer co-authored “Applying Civil Rights Law to Clinical Research: Title VI’s Equal Access Mandate,” published in The Journal of Law, Medicine & Ethics. Title VI of the Civil Rights Act of 1964 prohibits federally-funded educational institutions and health care centers from engaging in discrimination “on the ground of race, color, or national origin.” The authors argue that the Department of Health and Human Services (HHS) “has not used the full arsenal of legal and policy tools at its disposal to push for equal rights” to obligate institutions that receive federal funding for clinical research “to provide equal access to participation in clinical trials to racial and ethnic minority communities.” Read More
March 7, 2022: MRCT Center colleagues Barbara E. Bierer, Laura G. Meloney, Hayat R. Ahmed, Sarah A. White authored a commentary in Cell Reports Medicine, “Advancing the inclusion of underrepresented women in clinical research.” Read more
March 2022: The Proceedings from the National Academies of Science, Engineering and Medicine (NASEM) workshop “Adoption of Health Literacy Best Practices to Enhance Clinical Research and Community Participation” were released in March. Barbara Bierer, Elizabeth Cahn, and Sylvia Baedorf Kassis, are featured. Read more
April 8, 2022: Deborah Zarin, MRCT Center Program Director, co-authored “Completeness of clinical evidence citation in trial protocols: A cross-sectional analysis,” published in Med, Cell Press. The authors conclude that “clinical trial protocols undercite accessible, relevant trials and do not document systematic searches for relevant clinical trials. Consequently, ethics review committees often receive an incomplete picture of the research landscape if they review protocols similar to those deposited on ClinicalTrials.gov.”
April 2022: Dr. Barbara Bierer is featured in the Exploring Drug Discovery and Development article “Scientists and communicators team up to increase clinical trial participation,” that includes a look at clinicians, researchers, and communicators developing more effective strategies to disseminate information about clinical trials to reach a wider audience. Read more
WELCOME TO THE MRCT CENTER!
Nora Hutchinson, M.D.,C.M., MPhil, joined the MRCT Center in April 2022 as a Postdoctoral Research Fellow. Most recently, she worked under the supervision of Jonathan Kimmelman PhD at McGill University, funded by a Fonds de Recherche Santé Québec postdoctoral research grant. Her research focuses on the ethics, patient involvement, and clinical impact of pharmaceutical drug development.
Molly Siegeljoined the MRCT Center as a Student Researcher in the spring of 2022 working on a project related to trial termination. She will continue her involvement with the MRCT Center by providing data collection and analytic support across various ongoing projects at the Center.
A LOOK AHEAD
May 25, 2022: Sarah White will join plenary session 4 entitled “Mandatory vs. Mission Creep? The Role of DEI in IRBs and HRPPs” at the 2022 AAHRPP Annual Conference in Denver, CO.
June 14, 2022: The MRCT Center has organized a panel presentation at the BIO International Convention on June 14, 2022 from 4:15 PM – 5:15 PM PDT at the San Diego Convention Center. The panel presentation is titled “Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research.” Speakers will include Willyanne DeCormier Plosky (MRCT Center), Neha Londoño (Seagen), and Inez Ruiz-White (Otsuka).
Dr. Paul Farmer was the Kolokotrones University Professor, head of the Department of Global Health and Social Medicine in the Blavatnik Institute at Harvard Medical School, chief of the Division of Global Health Equity at Brigham and Women’s Hospital, and co-founder and chief strategist of Partners In Health. Dr. Farmer passed away suddenly on February 21, 2022, in Rwanda.
Paul was a public health luminary, true humanitarian, and brilliant scholar. He made a lasting impact on social justice in global health. Paul was a dear friend of the MRCT Center and we will strive to honor his legacy in our work.
Equity by Design in Clinical Research: Cancer Trials virtual training series recap
The MRCT Center hosted, in partnership with the Center for Cancer Equity and Engagement, Dana-Farber/Harvard Cancer Center, a six-part training series entitled “Equity by Design in Clinical Research: Cancer Trials.” Each module consisted of a 45-minute video lecture and 45 minutes of an interactive discussion session with experts in the field. Over 450 people were registered. All course registrants have until May 13 to finish viewing recordings and to complete their evaluation forms for credit. After May 13, all course materials will be made publicly available on the MRCT Center website (not for CME credit). More
Return of Individual Research Results (IRR) Website Launch webinar
This one-hour webinar will be moderated by MRCT Center Project Manager Lisa Murray and include a review of IRR and its importance, patient advocate Jamie Tyrone describing her own lived experience with IRR, and a live demonstration of the new tools and website.
The webinar will be hosted on March 24th from 1 pm-2 pm ET. Register now!
Learn more about our work on returning individual research results.
The second session of the MRCT Center Advancing International Pediatric Clinical Research webinar series: Informing the Future from COVID-19 Lessons Learned was held on February 2, 2022.
Webinar recordings and slides are now available. Subscribe for updates of future webinars in this series. MORE
Learn moreabout the MRCT Center Promoting Global Clinical Research in Children project.
This video, produced by Dr. Gianna “Gigi” McMillan in collaboration with the MRCT Center, features 3 young people from 3 continents, offering their thoughts on what researchers who work with young people should know.
This video, produced by International Children’s Advisory Network (iCAN) in collaboration with the MRCT Center, showcases young people from around the globe who have been involved in medical care and clinical research sharing some thoughts on what is important about including and listening to young people in clinical research.
MRCT Center welcomes a new sponsor!
The MRCT Center welcomes Mayo Clinic as a new Executive Committee member. Mayo Clinic is a nonprofit organization committed to clinical practice, education, and research, providing expert, whole-person care to everyone who needs healing. The MRCT Center is partnering with the Center for Clinical and Translational Science (CCATS), which is a central hub for institutional advancement of research and education at Mayo Clinic. The center provides tools and expert consultation to support every aspect of medical research.
On Thursday March 3, 2022 from 5:30pm-7:30pm EST: MRCT Center Program Manager Willyanne DeCormier Plosky, DrPH will be presenting on “Inclusion of People with Disabilities in Clinical Trials” at the 4th Annual Clinical Research Nurse meeting being hosted by the MGH Clinical Research Nurse Collaborative, the MGH Munn Center for Nursing Research and the Boston-New England Chapter of IACRN. The program for the meeting will focus on educating a community of CRNs on the importance of diversity, equity, and inclusion in clinical research, with a focus on clinical research nursing. Register now
PUBLICATIONS
JANUARY 31, 2022: MRCT Center Faculty Director, Barbara Bierer, with Executive Director, Sarah White, and Program Manager, Sylvia Baedorf Kassis authored a manuscript “Developing a consensus-driven, plain-language clinical research glossary for study participants and the clinical research community” in the Journal of Clinical and Translational Science. Read now
FEBRUARY 4, 2022: MRCT Center Program Manager, Sylvia Baedorf Kassis wrote about “How To Use Plain Language in Clinical Research Communications” in the Institute for Healthcare Advancement (IHA) blog. Read now
FEBRUARY 22, 2022: 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.” The MRCT Center appreciates the NIH’s efforts to update its policy to maintain currency with evolving technology and understanding. Detailed comments and suggestions can be found here. Read more
