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August 2023 Newsletter

In the Spotlight

Returning Individual Research Results and Data: Digging Deeper Webinar Series

Please join us for the final session of our three-part summer webinar series about the specific ethical, operational, and technical challenges to returning individual research results and data on Thursday, September 21, from 12 – 1 PM.

Based on this case study, the webinar will feature a moderated discussion with Megan Frone from the National Cancer Institute about considerations when returning genetic/genomic results.

Click here to register.

Two earlier webinars in this series explored Pfizer’s Patient Data Return Solution and IRB/HRPP responsibilities.

Diversity Convergence Project

Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. The Diversity Convergence Project, initiated by the Clinical Trials Transformation Initiative (CTTI), FasterCures, the Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies of Sciences Engineering and Medicine (NASEM), seeks to catalyze system-level changes to achieve racial and ethnic diversity in U.S. interventional clinical trials. To fully harness the potential impact and scalability, aligning goals collaboratively with colleagues across the enterprise is essential.

The MRCT will host a meeting on September 22 (invitation only) as part of a series of meetings to drive collaborative actions over the next year. This endeavor prioritizes areas that can truly transform clinical trials, necessitating collective action. The project focuses on eight key domains:

*Public Awareness
*Community Investment
*Community Engagement
*Workforce Diversity
*Site Enablement
*Comprehensive Data Utilization
*Funding, Finances, and Support
*Access and Inclusive Participation

Please stay tuned for forthcoming updates regarding this initiative.

JTF Framework: Chinese Translation

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 Chinese.

Other available translations: English, Spanish, French, Japanese, Thai, Bahasa Indonesia, Italian and Vietnamese.

Thank you to the School of Public Health: Capital Medical University, Beijing Tiatan Hospital: Capital Medical University, and Xunyuan for their effort and commitment to creating this translation.

Register for the Joint Task Force for Clinical Trial Competency Biannual Meeting

The next JTF biannual global meeting has been scheduled for November 14, 2023. Please register here to learn about or present updates and coordinate ongoing activities.

COVID-19 “Should I Join …?” Flyers now in Urdu

The MRCT Center and Harvard Catalyst collaborated in 2020 on a series of clinical research handouts with general information to prepare potential trial participants before recruitment and consent. Several of those brochures have now been translated into Urdu, in addition to English and Spanish.

Thank you to Dr. Farah Asif, Shahtaj Baig, and colleagues at the Shaukat Khanum Memorial Cancer Hospital and Research Centre in Lahore, Pakistan, for their help in adapting and translating the text.

Events & Presentations

September 11, 11 AM – 12:30 PM: Dr. Barbara Bierer will participate in the inaugural Stanford Think Tank on Diversity and Health Equity in Clinical Trials.

September 15, 11 AM – 12:30 PM: Dr. Barbara Bierer will present on a panel entitled, “Use of Regulatory Headwinds to Manage Towards Properly Enrolled Clinical Trials, at the 2023 AAADV (Accelerating Anticancer Agent Development and Validation) Workshop. Learn more about the three-day conference, September 13-15, here.

September 19, 10 AM – 12:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Where are we now with Data Privacy, Export Controls, and Foreign Influence? Open to R3 Sponsors.

September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper Session 3: Genetic Testing (see Spotlight above)

September 22: Diversity Convergence Meeting (see Spotlight above)

September 27: Dr. Bierer will address “Diversity Equity and Inclusion in IRB Review and Oversight” at the HHS OHRP Research Community Forum event co-sponsored with the University of Michigan Human Research Protection Program. The conference, Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data, takes place September 26-27, 2023 as an in-person event. Learn more here.

October 4-5: Dr. Bierer will participate and present at a two-day in-person Regional Workshop, co-sponsored by the Pan American Health Organization/World Health Organization (PAHO/WHO), and the Department of Evidence and Intelligence for Action in Health (EIH). The meeting, to be held in Brasilia, Brazil, will address strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.

October 10, 1:00 PM – 3:30 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: The Chat is out of the Bag: The future of AI in Clinical Research. Open to BC Sponsors.

Publications

July 14: MRCT Center Senior Advisor Luke Gelinas, former MRCT Center Project Manager Walker Morrell, and Faculty Director Dr. Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure participants’ privacy interests and rights. The article “Terms and Conditions Apply: An Ethical Analysis of Mobile Health User Agreements in Research” was published in the Journal of Law and Biosciences.

July 29: Colleagues in the UK, led by Annabelle South and assisted by Dr. Barbara Bierer, assessed site staff experience in returning plain language summaries to participants after trial completion. Not only did the staff feel that the communication was important, but there were no concerns or challenges in responding to participant questions. Operations and cost were both feasible. The resulting article, “Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial,” was published in Clinical Trials.

July 31: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to clarify further and expand the Agency’s recommendations.

August 9: As an outgrowth of an international workshop held in Dec 2022, Dr. Bierer collaborated with experts in multiple sclerosis to develop recommendations regarding diversity and inclusivity of participants in clinical trials investigating multiple sclerosis. Their recommendations, “Enhancing diversity of clinical trial populations in multiple sclerosis,” were published in the Multiple Sclerosis Journal.

August 11: Former MRCT Center Project Manager Laura Meloney, MRCT Center Project Manager Hayat Ahmed, and Dr. Barbara Bierer coordinated a modified Delphi process to establish consensus on recommendations for IRBs/ethics committees and institutions to promote diversity and inclusion in interventional clinical research. In this paper, they discuss the 25 consolidated recommendations across four themes. The article, “Review of diversity, equity, and inclusion by ethics committees: a Delphi consensus statement,” was published in Med (CellPress).

August 29: Dr. Barbara Bierer co-authored a commentary, “The Unresolved Challenge of Triage,” exploring the ethical and legal challenges of allocating limited care resources in a disaster setting in JAMA.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

July 2023 Newsletter

In the Spotlight

Returning Individual Research Results and Data: Digging Deeper Webinar Series

The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate.

The recording, slides, and related materials from the first webinar, Pfizer’s Participant Data Return Solution, held on July 27, will be posted to our website in August.

Please join us for the two remaining sessions by registering below.

Session 2: IRB and HRPP Responsibilities

Thursday, August 17, 12 – 1:00 PM ET: Linda Coleman and Madelon Baranoski of Yale University will discuss a case about returning non-validated test results.

Session 3: Genetic Testing

Thursday, September 21, 12 – 1:00 PM ET: Megan Frone of the National Cancer Institute will discuss a case about returning secondary findings.

Developing a model Diversity Action Plan (DAP) for Trial Sponsors

The Food and Drug Omnibus Reform Act of 2022 (FDORA) implemented new requirements for clinical trial diversity. Sponsors of late-stage drug and device trials must submit “diversity action plans” (DAPs) outlining their diversity goals for enrollment in the clinical study, the rationale behind those goals, and their strategies to achieve them. Therefore, the MRCT Center is developing a model DAP based on the MRCT Center’s Recruitment Strategy Document Template.

We have already identified important themes and considerations that will enhance the effectiveness and impact of these DAPs. To strengthen the completeness and applicability of this initiative, the MRCT Center is actively gathering DAPs from trial sponsors. If you have one or more examples of a DAP template that you would be willing to share, please email hahmed@bwh.harvard.edu. We will anonymize and use only to build the best DAP template we can.

Promoting Global Clinical Research in Children at the iCAN Summit

MRCT Center Program and Team Director Lisa Koppelman participated in an iCAN multi-disciplinary panel on pediatric clinical trials. The annual iCAN Summit is organized by the International Children’s Advisory Network (iCAN), a consortium of Young Persons Advisory Groups (YPAGS) that advocate for children and families in medicine, research, and innovation.

The MRCT Center and iCAN have collaborated closely to inform and center children’s voices in clinical research. iCAN youth participated in the review of the MRCT Center’s informational materials tailored to a pediatric audience interested or involved in clinical research. iCAN produced three videos showcasing the youth perspective on various research and clinical care aspects. These videos premiered in three of the MRCT Center’s five-part webinar series, Advancing International Pediatric Research.

In a delightful full-circle moment at the iCAN Summit, Lisa shared a warm, in-person exchange with Meg, the spotlight feature of a short video sharing the importance of keeping children well informed throughout the trial journey.

Click here to learn more about the MRCT Center’s pediatric work and the Including Young People in Clinical Research Toolkit.

Events & Presentations

July 27: MRCT Center Program Director Sylvia Baedorf Kassis led a moderated conversation in the first session of a 3-part webinar summer series, Returning Individual Results and Data: Digging Deeper – Pfizer’s Participant Data Return Solution. In August, webinar resources, including the recording, slides, and related materials, will be posted to the MRCT Center website.

August 17: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper

Session 2: IRB and HRPP Responsibilities (see Spotlight above)

September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Data Privacy and Foreign Influence. Open to R3 Sponsors.

September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper

Session 3: Genetic Testing (see Spotlight above)

Publications

June 19: MRCT Center Faculty Director Dr. Barbara Bierer and Program Director Sylvia Baedorf Kassis published an article, “Communicating complex numerical information in clinical research,” in Frontiers in Communication, stressing the importance of numeracy as a component of health literacy.

June 30: The MRCT Center submitted public comments to the Institute for Clinical and Economic Review (ICER) regarding proposed changes to the 2023 Value Assessment Framework. Click here to view.

July 5: MRCT Center co-Faculty Directors Dr. Barbara Bierer and Mark Barnes submitted public comments on the NIH Updated Policy Guidance for Subaward/Consortium Agreements, recommending that the guidance be updated to provide greater flexibility to institutions as to the types of documentation that foreign sub-recipients may be expected to share with prime awardees. Click here to view.

July 30: The MRCT Center submitted public comments on the proposed revision of the EU general pharmaceuticals legislation. In broad support of merging the Paediatrics Regulation with general pharmaceuticals legislation, our comments urged the European Commission to ensure pediatric medicines development remains an implementation priority to meet the needs of children throughout Europe. To read the full public comment, click here.

July 2023: The MRCT Center’s work in collaboration with Medable, Inc., on IRB/EC Considerations for DCT Review continues to garner attention in several publications:

·      ACRP
·      CenterWatch
·      PM360
·      PharmaVoice

MRCT Center Updates

The MRCT Center welcomes Erin Chaves, Administrative Coordinator. She contributes to the Center’s successful operations, including financial and administrative tasks, management of events, coordinating calendars, and other administrative duties.

Summer Reading

Developing imagery for the Clinical Research Glossary

This summer, after reviewing over 200 applications, the MRCT Center welcomed student interns Yimeng (Anna) Lyu and Xinyu (Sandra) Ye to work with MRCT Center colleagues to develop graphic design products for Health Literacy, Individual Return of Results, Diversity, Pediatrics, and other Center projects. They have focused on a comprehensive Clinical Research Glossary graphics library to accompany the plain-language definitions. All images will eventually be available for free use under the terms of our Creative Commons license.

“We hear repeatedly from patients and industry professionals how important images are to effective communication and understanding,” said Program Director Sylvia Baedorf Kassis. “We are thrilled to be able to meet this need while providing an educational opportunity for the next generation of science communicators. This effort crystallizes the MRCT Center’s commitment to promoting a holistic approach to clinical research understanding.”

For Sandra, a junior at Vanderbilt University majoring in Cognitive Studies and Communication of Science and Technology, the work has been an opportunity to meld two interests: science communication and graphic design. “It has been an incredible experience being part of the Health Literacy project team and seeing how a glossary can significantly improve health communication. I focus on visualizing common yet complex research concepts for potential clinical trial participants. I am grateful that my passion and ideas are appreciated here. Receiving feedback from my multi-talented colleagues is enlightening, and I look forward to seeing our combined efforts come to fruition.”

MRCT Center Project Manager Kayleigh To has been working closely with the interns. “Just as the plain language definitions go through a rigorous and iterative review process, these images undergo a similar creative development,” she said. “Ideas for the images are brainstormed before multiple drafts are created, each building upon and incorporating feedback and input. Such care and consideration are a hallmark of the work to create the glossary.”

Anna, a Fine Arts major with a concentration in Graphic Design at Tufts University, sees the work as an enriching and challenging opportunity to innovate in the intersection of art and science. “As part of a multidisciplinary team, I bring my expertise in art and design to create brand-aligned visual assets, including illustrations, icons, and a style guide. With user-centered and inclusive design, I aim to craft visuals that simplify complex concepts for diverse audiences. I am proud that our work will enhance health literacy and empower individuals to make informed decisions about their participation in clinical research.”

The MRCT Center’s Clinical Research Glossary currently has 53 plain-language terms. A bank of 118 additional words has recently undergone an extensive public review with CDISC and is slated to be added to the glossary by the end of the year.

Click here to read more about our process of developing a consensus-driven, plain-language clinical research glossary.

Click here to learn more about the MRCT Center’s collaboration with CDISC to make our plain-language clinical research glossary a global standard.

Learn more about becoming an MRCT Center sponsor.

June 2023 Newsletter

In the Spotlight

The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). Together, they presented a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20.

MRCT Center Faculty Director Dr. Barbara Bierer and Medable’s Dr. Pam Tenaerts and Leanne Madre presented guidance and tools organized around 12 key elements during the webinar. These elements are grouped into three domains: People, Remote Data Collection, and Data Oversight. The aim is to provide IRBs, ethics committees (ECs), and sponsors with a framework, tools, recommendations, and best practices for conducting ethical review. Advarra representative Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.

For more about the IRB/EC Considerations for DCT Review, click here.

Click here to view the webinar resources, including the recording and presentation slides.

Joint Task Force for Clinical Trial Competency (JTF) News

The MRCT Center hosted a biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) on May 2. The meeting included updates from various members of the JTF and progress reports from workgroups, including Data Management and Informatics, Assessment, and Emergency Preparedness.

Click here to read the meeting summary.

The next biannual global meeting has been scheduled for November 14, 2023. To learn about or present updates and coordinate ongoing activities, please register here.

A Global Plain-Language Standard: MRCT Center Glossary Public Review

The MRCT Center continues to lead the co-creation of a plain-language clinical glossary. As a new CDISC global standard, the MRCT Center Clinical Research Glossary is being developed by a workgroup of dedicated volunteers, including patients, advocates, research professionals, medical writers, and others, to deliver understandable and valuable research information to a broad audience.

As part of the process, a CDISC public review period is currently open for 118 new words and definitions.

Here is the link to the public review package.

We have included a helpful video to guide you through submitting a review.

Please click here for more information about the MRCT Center glossary and our collaboration with CDISC to create a plain-language global standard.

Pediatric Brochures in Arabic

We are delighted to share that several pediatric educational brochures to explain aspects of clinical research have been translated into Arabic by our colleagues at the King Hussein Cancer Center in Amman, Jordan. We are grateful for this ongoing collaboration.

· What is Clinical Research?

· What is Assent?

· What is Assent to Consent?

· What happens at the end of a Research Study?

Stay tuned for translations into additional languages! Please contact Lisa Koppelman at ekoppelman@bwh.harvard.edu if you are interested in partnering to translate and adapt these or any of our other pediatrics-focused materials.

Events & Presentations

June 21-22: The MRCT Center leadership hosted External Advisory Board and Executive Committee meetings in Cambridge, MA. These meetings focused on the MRCT Center’s strategic planning and vision of our work, which are critical steps in our efforts to develop innovative solutions and aligned approaches to global clinical research.

June 27 and 28: Faculty Director Dr. Barbara Bierer presented IRB/EC Considerations for Ethical Review and PI Oversight at the DIA conference in Boston.

June 28: Program Director, Sylvia Baedorf Kassis MPH, presented “Returning Individual Participant Data: A Cultural & Operational Shift Towards Personalized Clinical Trial Options” at the DIA conference in Boston.

July 27, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 1: Pfizer’s Participant Data Return Solution (see Spotlight above)

August 17, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 2: IRB and HRPP Responsibilities (see Spotlight above)

September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3)

Topic: Research Collaboration with China. Open to R3 Sponsors.

September 21, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 3: Genetic Testing (see Spotlight above)

Publications

May 25, 2023: MRCT Center Program Director Dr. Deborah Zarin co-authored an article, “Bringing data monitoring committee charters into the sunlight,” in Clinical Trials, addressing the lack of access to data monitoring committees (DMCs) charters and calling on the NIH to allow their voluntary upload into ClinicalTrials.gov.

June 2023: The MRCT Center’s work on IRB/EC considerations for DCT review with Medable, Inc. was cited in several publications:
·      Biospace
·      Applied Clinical Trials
·      Contract Pharma
·      Trial Site News
·      Clinical Trials Arena
·      Clinical Research News
·      Clinical Trials Arena/INFORMA

Quotable Quote: June 7, 2023: MRCT Center Program Director Sylvia Baedorf Kassis was quoted in an article, “Patient Data Return: Do the Benefits Outweigh the Barriers?” in Applied Clinical Trials Online, speaking about the importance of returning individual results and data to Clinical trial participants.

May 2023 Newsletter

In the Spotlight

Upcoming Webinar: June 20th from 10 – 11 AM ET

Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices

The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). We invite you to join us on June 20, from 10 – 11 AM ET, for a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”

During the webinar, Barbara Bierer (MRCT Center), Pam Tenaerts (Medable) and Leanne Madre (Medable) will present a framework, recommendations, and tools organized around 3 DCT domains: People, Remote Data Collection, and Data Oversight. Best practices for the ethical review, approval, and conduct of DCTs will be provided.

We invite clinical trial stakeholders (IRB/ECs, HRPP, sites, sponsors, investigators, and others) to register for the webinar. Please click here to register.

Accessibility by Design (AbD) Toolkit and Resources

The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.

On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.”

The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research.

Dr. Bierer at the African Vaccine Regulatory Forum (AVAREF)

Dr. Barbara Bierer attended the semi-annual African Vaccine Regulatory Forum (AVAREF) meeting in Yaoundé, Cameroon, in April. She presented on the MRCT Center’s efforts to build the capacity of, and to develop tools, training, and resources for, ethics committees across Africa. In addition, with AVAREF leadership, she reported on her visits to Kenya and Nigeria to optimize the conduct and timing of interventional clinical trials.

Return of Individual Research Results and Data: Case Study Resources

On May 2, the MRCT Center hosted the webinar “Returning Individual Research Results and Data to Participants: Experience from the Field.” Over 200 people joined live to hear five leaders from across the clinical trials ecosystem share their experiences supporting participants and designing and implementing institutional procedures to receive individual research results and data.

Thank you to our panelists and attendees for such an engaging session. Click here for a summary of the webinar Q&A with responses to questions we didn’t have time to address live.

Click here to view a full webinar recording, download slides, and access the MRCT Center’s Return of Individual Results resources on our dedicated website.

Additional Translations of the Joint Task Force (JTF) Core Competencies

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 Italian and Vietnamese.

Other available translations: English, Spanish, French, Japanese, Thai, and Bahasa Indonesia.

The MRCT Center at AAHRPP

Dr. Barbara Bierer and Linda Coleman, JD, Director of the Human Research Protection Program at Yale University, delivered a joint session on the Ethical Review of Decentralized Clinical Trials (DCTs) at the 2023 AAHRPP conference. Challenges in the IRB review of DCTs, as well as institutional HRPP concerns, recommendations, tools, and resources, were discussed at the session.

Sylvia Baedorf Kassis, Program Director at the MRCT, and Jonathan Miller, Associate Vice President for Research Regulatory Oversight at the University of Alabama at Birmingham, discussed the roles and responsibilities of HRPPs in returning aggregate and individual research results, emphasizing the need for a comprehensive, operational plan for returning results return program throughout the study lifecycle. Key resources were also reviewed to support researcher-participant engagement.

Hayat Ahmed, Program Manager at the MRCT Center, showcased tools and resources for incorporating diversity, equity, and inclusion (DEI) in IRB/HRPP processes. The 15 tools developed by the MRCT Center in collaboration with task force members were presented. Conference participants awarded Ms. Ahmed the distinguished poster award.

Events & Presentations

May 10: Dr. Barbara Bierer presented “Diversity, equity, inclusion, and Integrity in clinical trials: towards effective advocacy and action” at the SWOG Cancer Research Network annual meeting.

June 1 from 1:00 – 3:30 PM ET: Research, Development, and Regulatory Roundtable (R3) – open to Sponsors of R3.

Topics: (1) The Revolution in Online Behavioral Advertising – What it Means for the Research Enterprise, (2) Challenges in Decentralized Clinical Trials – Open Discussion Forum

June 20 from 10 – 11 AM ET: Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices (see Spotlight above)

Click here to register.

Publications

April 25: Dr. Deborah Zarin co-authored a research letter examining the proportion and timing of results dissemination for registered trials by data source, “Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type,” in JAMA.

April 26: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” in International Journal of Clinical Trials, describing the experience of conducting a multinational acupuncture study during the pandemic.

May 8: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry. See “Returning Individual Research Results from Digital Phenotyping in Psychiatry” in the American Journal of Bioethics.

May 25: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit, in Amp&rsand, the PRIM&R blog.

April 2023 Newsletter

In the Spotlight

IRR Case Study Release and Webinar: May 2

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 at 11 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.

Click here to register.

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).

Click here to register.

May 4: 11 AM – 12 PM ET

Accessibility by Design (AbD) in Clinical Research Toolkit Release and Webinar (see Spotlight above).

Click here to register.

May 12: 8:50 AM ET

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 7, 2023: Sylvia Baedorf Kassis, Kayleigh To, Sarah White, and Dr. Barbara Bierer coauthored an article, “Use Plain Language to Increase Understanding: the MRCT Center Clinical Research Glossary,” with Rhonda Facile of CDISC in DIA’s Global Forum about a recent collaboration with CDISC to expand access to the Clinical Research Glossary as a new global standard.

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.

March 2023 Newsletter

In the Spotlight

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.

Click here 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.

Click here to register.

Release of Including 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.

Other available translations: English, Spanish, French, Japanese, and Thai. Additional translations are in progress.

Translation in Bahasa Indonesia:

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

Last week’s Promoting Global Clinical Research in Children: Informing the Future webinar had over 400 registrants from 60 countries. The webinar was the fifth and final in an FDA-sponsored Scientific Conference Grant series: Advancing International Pediatric Clinical Research. In total, nearly 1500 people registered for the series from 83 countries.

To watch the webinar now, click here.

New Steering Committee Members

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.

Learn more about MRCT Center sponsors and sponsorship opportunities.

Events & Presentations

March 27

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.)

Click here to register.

April 5: 3 PM – 4 PM ET

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.”

Click here to learn more and register.

April 13: 1 PM – 3:30 PM ET

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.

Click here for more information and to register.

April 28: 1:00 PM ET

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.

Click here for more information and to register.

May 2: 12 – 1 PM ET

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.

Click here to register.

May 4: 11 AM – 12 PM ET

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 4^th, 2023, 11:00 am – 12:00 pm ET as we launch the Accessibility by Design (AbD) in Clinical Research Toolkit, a product developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.

Click here to register for the webinar.

Publications

March 8, 2023: The MRCT Center submitted comments to FDA on “Investigational New Drug Application Annual Reporting; A Proposed Rule.”

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.

The tool, entitled “Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products,” was published in Cell Patterns.

MRCT Center Updates

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.”

February 2023 Newsletter

In the Spotlight

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.

March 21: 9:00 AM – 11:00 AM EDT

Click here to register.

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.

To view these resources, click here.

Events & Presentations

March 2: 1 PM – 3:30 PM EST Research, 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!

For more information about the event, click here.

To register, click here.

March 21: 9:00 – 11:00 EDT / VIRTUAL CONFERENCE

Join us for the fifth and final part of the FDA-supported virtual conference series on Advancing International Pediatric Research: “Promoting Global Clinical Research in Children: Informing the Future.” (See Spotlight above.)

Click here to register.

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.

Learn More >

MRCT Center Updates

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.

Learn more about  becoming an MRCT Center sponsor.

January 2023 Newsletter

In the Spotlight: 2022 Annual Report

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.

Click here to register.

On November 29 & 30, 2022, the MRCT Center, supported in part by the FDA, hosted a virtual conference entitled “Advancing International Pediatric Clinical Research: Facilitating Pediatric Medicines Development: Models of Global Cooperation” that built on existing models of global regulatory cooperation to strengthen the international regulatory ecosystem for pediatric clinical trials.

Click here to view the webinar resources.

Joint Task Force for Clinical Trial Competency

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.

Click here to view.

Other available translations: English, Spanish, French, and Japanese.

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.

Click here to view the Chinese modules.

This Month at the MRCT Center

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 the Fondation 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’s Clinical 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, the Research, 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.

To learn more about Sponsorship, click here.

MRCT Center Updates

The MRCT Center welcomes:

Samjhana Bogati, Program Manager

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.

December 2022 Newsletter

In the Spotlight

MRCT Center Annual Meeting: December 14, 2022

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.

For the Annual Meeting agenda, click here.

Registration for in-person attendance is now closed, but we welcome virtual participation.

Please register here.

New Diversity Resources for IRB and HRPP

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:

Institutional Review Board Oversight Points to Consider for IRB Reviewers to assess DEI factors at Initial and Continuing Review

A Resource for HRPPs: Planning a Strategy to Address Diversity, Equity, and Inclusion

Integrating Considerations for Diversity, Equity, and Inclusion (DEI) into a Recruitment Strategy Document

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.

Learn more

PRESENTATIONS

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.

Learn more.

PUBLICATIONS

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.

September 2022 Newsletter

In the Spotlight

MRCT Center Annual Meeting: December 14, 2022

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).

Please register here.

MRCT Center Pediatric Brochures for Youth

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.

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.

And on August 2, 2022: James Miessler of WCG CenterWatch credited the Joint Task Force on Clinical Trial Competencies (JTF) in his blog Trial Professionals Need Formal Research Training to Fill Crucial Knowledge Gaps. Learn More

JOIN THE MRCT CENTER TEAM

The MRCT Center has the following job openings:

Senior Communications and Web Specialist
Program Manager, Education, and Training
Instructor or Assistant Professor Faculty position

Please forward to potential candidates!

A LOOK AHEAD

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 3^rd 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.