Sarah White and Barbara Bierer with Patience Odour, Head of Clinical Trials Unit, UGHE, Barbara Bierer at the University of Global Health Equity Campus in Butaro, Rwanda. Barbara Bierer and Sarah White at the offices of the Rwanda Food and Drug Authority in Kigali, Rwanda. Sarah White and Barbara Bierer with Professor Emile Bienvenu, Director General of the Rwanda FDA. along with senior members of the Clinical Trials Team The UGHE Ethics Committee. From left to right, back row: Vincent Cubaka, Director, Partners in Health, Rwanda; Patrick Orikiriza, Assistant Professor, Head of MIcrobiology at UGHE and Chair of the EC; Barbara Bierer, Sarah White, Agaba Don King, PIH attorney, Valentine Nyirahabimana, Administrative Assistant to the IGHER and IRB Secretariate, Augustine Ndaimani, Assistant Professor, Centre for Nursing and MIdwifery Front: Patience Odour, Head of Clinical Trials Unit, UGHE; Julia Hyman, Heal Fellow Dr. Julia Hyman, Heal Fellow; Piero Irakiza, Sr. Data Manager; Suman Dhanani, Sr. Research Coordinator; Barbara Bierer, Sarah White, Dr. Nathali Umutoni, Director of Operations; Caroline Makonese AVAREF Advisory Committee Sarah White and Barbara Bierer with Patience Odour, Head of Clinical Trials Unit, UGHE, Barbara Bierer at the University of Global Health Equity Campus in Butaro, Rwanda.
Barbara Bierer and Sarah White recently returned from a two-week work trip to Rwanda and Zimbabwe. The trip was motivated by the MRCT Center’s commitment to building clinical research capacity and a better understanding of local efforts to strengthen and sustain the clinical trial ecosystem. They first attended the African Vaccines Regulatory Forum (AVAREF) 14th Meeting of the Technical Coordinating Committee (TCC) and Steering Committee (SC) in Harare, Zimbabwe. The MRCT Center has partnered with AVAREF and, more broadly, with WHO for many years to build capacity for ethical review, optimize the integration of ethics review with regulatory processes, and strengthen the clinical trial ecosystem. To date, our work has included developing a fundamental research ethics training course (to be freely released in September 2024) and conducting site optimization visits to understand the challenges in clinical trial application reviews.
Dr. Bierer and Ms. White also spent time in Kigali, Rwanda, meeting with stakeholders, including the Rwanda FDA, Rwanda National Ethics Committee (RNEC), the University of Global Health Equity (UGHE), the UGHE Ethics Committee, the Butaro District Hospital, the Center for Family Health Research, and the Centre for Impact, Innovation, and Capacity Building for Health Information Systems and Nutrition (CIICHIN).
Working closely with the Bill and Melinda Gates Foundation and WHO, this trip provided significant insight into how the MRCT Center can collaborate with local stakeholders to improve the predictability, sustainability, and quality of clinical trials.
Description: New requirements for clinical trial sponsors to submit diversity action plans to the US Food and Drug Administration (FDA) are an important step to embed planning for diverse representation in clinical trial research. These must not, however, be implemented in ways that are detrimental to other countries’ health and research interests. It is possible for those making operational decisions on country and site selection to address the needs of underserved populations in other countries at the same time as meeting US regulatory expectations — for example, by addressing barriers to diverse recruitment. Site selection should follow purposeful engagement in the local and regional culture, considering the needs of the local population, and proceed only if the trial is responsive to those needs.
The critical role of representation in clinical research, particularly for LGBTQIA+ communities, and an overview of the foundations supporting the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit.
Essential considerations for collecting SOGI data, covering survey and form design, appropriate language in study materials, and the protocols for collecting, storing, and sharing SOGI data.
Practical implementation examples and areas that require further research and guidance.
Federal Committee on Statistical Methodology (FCSM) Sexual Orientation, Gender Identity, and Sex Characteristics Subcommittee: https://www.fcsm.gov/groups/sogisc/
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Institute of Medicine (US) Committee on Lesbian, Gay, Bisexual, and Transgender Health Issues and Research Gaps and Opportunities. (2011). The health of lesbian, gay, bisexual, and transgender people. National Academies Press (US). Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/books/NBK64806/
Landers SJ et al. Sexual Orientation Differences in Asthma Correlates in a Population-Based Sample of Adults. Am J Public Health. 2011:101:2233-2244. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222437/
Fredriksen-Goldsen KI et al. Health and Access to Care and Coverage for Lesbian, Gay, Bisexual, and Transgender Individuals in the U.S. Am J Public Health. 2017:107:1332-1338. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5508186/
Hughes LD et al. Differences in All-Cause Mortality Among Transgender and Non-Transgender People Enrolled in Private Insurance. Demography. 2022;59:1023-1043. Accessed August 30, 2023. https://doi.org/10.1215/00703370-9942002
Morris M et al. Training to reduce LGBTQ-related bias among medical, nursing, and dental students and providers: a systematic review. BMC Medical Education. 2019;19:325. Accessed August 30, 2023. https://doi.org/10.1186/s12909-019-1727-3
Dahlhamer JM et al. Barriers to Health Care Among Adults Identifying as Sexual Minorities: A US National Study. Am J Public Health. 2016;106:1116. Accessed August 29, 2023. https://doi.org/10.2105/AJPH.2016.303049
Sterling J et al. Cancer screening in the transgender population: a review of current guidelines, best practices, and a proposed care mode. Transl Androl Urol. 2020;9(6):2771-2785. Accessed August 7, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7807311/
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Brown I, McKenzie M, Srirangam A, Patel S. Making an Inclusive Impact: LGBTQ+ Health Equity in Clinical Trials. Poster presented at Drug Information Association Global Annual Meeting: June 25-29, 2023; Boston, MA.
Data on File. Genentech, Inc. South San Francisco, CA.
Learn how four organizations, Mass General Brigham (MGB) Rally, HonorHealth, the Society for Clinical Data Management (SCDM), and the CureMito Foundation, are implementing the MRCT Center’s Clinical Research Glossary and how you can participate in Public Review, a vital process to ensure the glossary is a CDISC global standard.
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. Despite recent legislative efforts to improve diversity in clinical trials, and many individual organizational efforts, a national plan to include diverse patients does not exist.
Please note, the 4th [hybrid] meeting in this series, entitled “Toward a Framework to Improve Diversity and Inclusion in Clinical Trials,” will be hosted by NASEM in Washington DC on May 20. You can find out more information and register here. This workshop will build on the National Action Plan. We will be focusing on commitment to strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.
The MRCT Center submitted a response to a draft ethics charter intended to protect healthy volunteers in clinical trials published by the French National Institute of Health and Medical Research (“INSERM”). The draft ethics charter consisted of 17 proposed articles; the MRCT Center offered general commentary on the entire charter and provided feedback and/or recommended new language on 14 of the 17 articles. Broadly, the MRCT Center wholly supports the development of an ethical charter to protect healthy trial participants. Our comments reflected our support for the broader endeavor while remaining dedicated to helping INSERM craft language that reflects their well-intentioned goal.
