Key Dates
Launch: March 6, 2024
Due: April 23, 2024
Closed
For more information:
Email UsProgram Rationale
In this funding cycle, NIH/NCATS (NIH National Center for Advancing Translational Sciences) required all Clinical and Translational Science Centers (CTSCs), including Harvard Catalyst, to identify and then mitigate roadblocks that impede health-related research at their institutions.
One of the blocks defined at Harvard was the problem of “limited access to and participation of diverse populations in research,” a problem common to many institutions performing clinical and translational research.
A recent ideation challenge offered to the Harvard community identified as under-addressed numerous issues that contribute to failures of inclusivity related to participation in clinical research studies. In response to this feedback, this Request for Applications (RFA) is focused on the broad topic of improving inclusivity in research studies with an emphasis on overcoming classes of obstacles identified by our own community, which include a range of disabilities and socio-economic barriers.
Goals
This RFA seeks innovative pilot translational science initiatives aimed at augmenting inclusivity of clinical trials at all levels of engagement, including enrollment and participation.
Specifically, the focus is on characterizing and addressing obstacles faced by individuals or groups in accessing or participating in clinical research studies, with the goal of fostering a more inclusive and representative research landscape.
In addition to issues that have and continue to receive attention, such as race and gender, our community highlighted the obstacles experienced related to sensory, mobility, and cognitive disabilities, and impediments imposed by locoregional or socioeconomic circumstances.
Limited awareness within the research community regarding such impediments and their potential remediation can further create additional obstacles.
Description
Examples of topics that would be responsive to this RFA include but are not limited to the following:
- Pilot approaches that could lead to new analytic frameworks, strategies, interventions, or changes in practice to address the persistent racial disparities in kidney transplantation.
- Characterization of the frequency or nature of sensory, mobility, and cognitive disabilities or other impairments or limitations as a deterrent to access, enrollment, and participation in clinical trials.
- Validation of existing or pilot deployment of novel aids, interventions, or other supports for those with sensory, mobility, and cognitive disabilities or other impairments or limitations, the goal of which is to increase capacity to access, consider, consent, and participate in clinical trials.
- Development or validation of approaches to mitigate or eliminate obstacles to research participation conferred by socioeconomic constraints (e.g. limited access to necessary transportation, wifi access, childcare, or limited job flexibility).
- Studies of novel approaches that address participation in clinical trials or validation of trial results in special populations. For example, prisoners, pregnant women, and those suffering from neurocognitive diseases.
- Innovative characterization of or pilot interventions or approaches to the cultural and linguistic sensitivity and competency of trial recruitment, enrollment, and conduct practices.
- Proposed addition of a translational science component to an existing clinical trial, such as studying why patients cancel/miss required study appointments or characterizing physical or socioeconomic aspects of participation that were challenging or limiting.
Translational Science
The term “translational science” and its relation to “translational research” may be new or unclear to many potential applicants. Translational research is defined by NIH/NCATS as “the endeavor to traverse a particular step of the translational process for a particular target or disease. Translational science is the field of investigation focused on understanding the scientific and operational principles underlying each step of the translational process. Whereas translational research focuses on the specific case of a target or disease, translational science is focused on the general case that applies to any target or disease. A key tenet of translational science is to understand common causes of inefficiency and failure in translational research projects for example incorrect predictions of the toxicity or efficacy of new drugs, lack of data interoperability, ineffective clinical trial recruitment.”
A more extensive statement and examples of the difference between translational research and translational science are provided in the Application Guide below.
Awardees
Principal Investigator: Danielle Bitterman, MD, Brigham and Women’s Hospital
The goal of this research is to enhance the inclusivity of language in clinical trial materials to ensure they are clear and welcoming to a diverse range of participants. The project will employ advanced artificial intelligence (AI) technologies, specifically a type of AI known as large language models, to detect and modify language in clinical trial documents that may not be inclusive. The project consists of two main goals. First, we will develop AI technologies that monitor the language used in descriptions of trials, consent forms (which people sign to join a study), and study plans. These technologies will look for language that’s hard to read, not welcoming to all genders, or stigmatizing. Second, we will develop AI technologies that suggest more inclusive language that is easier for patients to understand. The anticipated outcome is a toolkit that can automatically detect non-inclusive language in clinical trial materials and offer suggestions for improvement. By fostering greater inclusivity in clinical trials, this research will build trust and improve participation among a broad range of diverse communities.
Principal Investigator: Nathaniel Harnett, PhD, McLean Hospital
Over 90% of the U.S. population will experience a traumatic event in their lifetime. Clinical
studies on the biological impact of traumatic stress are necessary to better understand and treat
related mental health conditions such as posttraumatic stress disorder (PTSD). However, to
ensure research findings help improve the lives of trauma survivors from all backgrounds, study
samples must be representative of the population. In general, individuals from disadvantaged
socioeconomic backgrounds, and underrepresented racial and ethnic groups are less likely to
complete clinical research studies. In addition, many clinical studies have time-intensive and
complex protocols, such as providing a blood specimen or completing a neuroimaging scan.
Participation in these research activities may increase participant burden by requiring longer or
more frequent study visits. Neighborhood factors – such as access to public transportation,
socioeconomic deprivation, or community violence – may also deter individuals from
participating in research. In the largest longitudinal cohort study of traumatic stress to date, the
current project will characterize structural barriers to research participation from GPS data,
satellite imagery, and publicly available datasets. Ultimately, the project will reveal actionable
community targets to improve the representation of participants in clinical research and inform
the recruitment strategies of future studies.
Principal Investigator: Levi Kanu, MD, Massachusetts Eye & Ear
We are interested in figuring out why people with keratoconus (KCN) agree or decline to participate in clinical trials. KCN is an eye condition that affects the shape of the cornea and can lead to severe vision problems. KCN is more common in certain groups, and we have noticed that these groups often have worse KCN-related problems. These same groups of people often choose not to participate in clinical trials. If our trials do not include a diverse group of patients, we might not fully understand how KCN develops in all patients. In the proposed research, we are seeking to understand what causes some KCN patients to not participate in clinical trials and see if there are ways to improve access to trials. Our goal is to make sure everyone has a fair chance to benefit from clinical trials related to KCN.
Principal Investigator: Caroline Kaufman, PhD, McLean Hospital
Spirituality/religion (s/r) are important aspects of identity and experience among many Americans. However, s/r minorities and religiously observant individuals are underrepresented in behavioral health science research and likely experience a variety of barriers to research participation. This problem is compounded by the lack of recognition of and training in the recruitment of these groups in behavioral health research. To address this gap and expand the inclusiveness of behavioral health research, we propose to develop a set of applicable and actionable recommendations to recruit and engage s/r minorities and religiously observant individuals in research. To achieve this overarching aim, we are seeking funding to support the completion of a Delphi panel with religious leaders to develop a set of recommendations for researchers. A priori standards for consensus, stability, and other criteria will be developed during Phase I of the project. During Phase II, panelists will be recruited and the PI will lead the a Delphi panel to obtain consensus on recommendations. Findings will be disseminated via peer-reviewed publication, local and national presentations, and anticipated consultation with MGB researchers. Finally, project findings will be used to support additional fundings submissions to further evaluate recommendations and to develop recommendations for inclusion of these populations in additional areas of research (e.g., health research).
Principal Investigator: Einat Liebenthal, PhD, McLean Hospital
Stroke often leads to aphasia, a language disorder that makes communication difficult. People with aphasia, especially from disadvantaged backgrounds, face challenges participating in research to develop better treatment and diagnostic methods. Critically, their exclusion means these interventions may not address their unique needs. This project tests strategies to help people with aphasia, particularly from underserved groups, take part in research more easily. Approaches include targeted outreach to urban and rural areas, hiring diverse multilingual staff, offering flexible scheduling and remote options, involving family and community in recruitment, using accessible materials relatable to all backgrounds, covering costs like travel, lodging, food, and technology, and providing periodic check-ins and support from staff. These strategies will be tested by recruiting a diverse group of 80 people with aphasia into an ongoing study using movie clips to measure language abilities in a naturalistic way, involving measures of emotion, eye-tracking, and brain imaging in some participants. If successful, the recruitment methods could apply to research performed with other clinical populations, such as Alzheimer’s disease and dementia, with the goal of making research more inclusive so treatments can help more people more effectively. Improving participation in research may synergistically improve access to clinical care as well.
Principal Investigator: Ankur Pandya, PhD, MPH, Harvard T.H. Chan School of Public Health
In survey of 137 physicians published in 2023, researchers found that 72% of these physicians responded that they were asked by their patients whether a treatment will ‚ “work in people like me”. Increasing representation, defined broadly, in clinical trials will help answer this question and help improve real-world uptake of effective interventions in historically under-represented populations. There are limited resources, and in some settings available study participants, to sufficiently increase representation in all clinical trials, however. In this proposal, we aim to develop and apply a formal framework that quantifies potential sources of value from increased trial representation. This framework broadly asks the questions: How are the worlds with and without sufficient trial representation different? What is the probability that study results would change with and without such representation? What clinical and policy decisions would change, and under what conditions are the additional study costs of increasing representation justified using economic evaluation methods? These are difficult but real challenges facing funders and researchers, and our framework aims to provide information that can guide limited research resources to the studies that would provide the most value from increased representation to, in part, avoid over-burdening wiling trial participants from under-represented populations.
Principal Investigator: Tony Pham, MD, Massachusetts General Hospital
This study proposes to address chronic pain and memory related problems in the older Black community by culturally adapting mindfulness-based cognitive therapy, a group therapy with evidence for chronic pain and memory related problems. Among older Black individuals, chronic pain occurs with memory related problems, and these issues worsen physical and brain health; however, Black individuals face multiple barriers to accessing talk therapies that address pain and prevent memory related problems. A culturally tailored mindfulness-based cognitive therapy may be an effective and efficient solution to improve physical and brain health among this underserved population. In preparation of this proposed study project, I formed a community advisory board composed of older Black individuals with chronic pain and memory related problems and facilitated group conversations with this community advisory board to explore whether mindfulness-based cognitive therapy would be accepted within the older Black community. These group conversations suggested that mindfulness-based cognitive therapy is accepted by older Black individuals with chronic pain and memory related problems but only if the intervention is shortened and delivered by an individual from the Black community. We then developed a preliminary manual for a cultural tailored MBCT for older Black individuals with chronic pain and memory related problems titled “Feeling of Being”. This proposal will continue the development of Feeling of Being by training a Black individual from the community to deliver Feeling of Being and again test its acceptance by the community.
Principal Investigator: PhD, Massachusetts General Hospital
There is an urgent need to increase ethnic and racial diversity in clinical research focused on aging, Alzheimer’s disease (AD), and related dementias. It is critical that AD researchers increase diversity in their studies to guarantee clinical care that benefits the entire population and reduces health disparities. This proposal aims to improve our understanding of the barriers preventing Latino individuals from accessing information about clinical research opportunities. Additionally, we seek to investigate why Latinos, already familiar with research studies and clinical trials, may choose not to participate. To accomplish these objectives, we will: 1) develop a culturally relevant educational workshop and evaluate its effectiveness in raising awareness of dementia and fostering positive attitudes towards clinical research participation; and 2) analyze the factors influencing the motivation and interest of Latinos in engaging with Alzheimer’s disease clinical research, both pre- and post-exposure to information on its importance.
Application Guide
This RFA seeks translational science proposals that aim to expand the inclusivity of clinical trial participation, with a focus on identifying and addressing barriers faced by individuals or groups in accessing or participating in clinical research studies.
As the concept of translational science (TS) and its connection to the more commonly known translational research (TR) may be unfamiliar to some applicants, NIH/NCATS offers these definitions:
Translational research (TR) is defined by NIH/NCATS as “the endeavor to traverse a particular step of the translational process for a particular target or disease. Whereas translational science (TS) is the field that generates innovations that overcome longstanding challenges along the translational research pipeline. These include scientific, operational, financial, and administrative innovations that transform the way that research is done, making it faster, more efficient, and more impactful.”
- Translational science aims to understand the common factors contributing to inefficiencies and setbacks in translational research endeavors.
- Examples of these setbacks include inaccurate predictions of drug toxicity or efficacy, issues with data compatibility, and suboptimal clinical trial recruitment.
- Many of these challenges transcend specific targets, diseases, and therapeutic areas. Therefore, advancements in translational science hold the promise of elevating the efficiency and efficacy of translational research.
- The ultimate goal is to improve overall health, extend life expectancy, and reduce the burdens of illness and disability. Much like any scientific discipline, translational science aims to elucidate universal operating principles, to transform translation from an empirical and phenomenological process into a predictive science.
The following is an example provided by NIH/NCATS
- An example of a traditional translational research project would be an investigator aiming to assess the efficacy of a specific drug in improving outcomes for diabetes by recruiting a sufficient number of participants using established recruitment methods to evaluate the drug’s effectiveness and its potential benefits for the diabetes community.
- In contrast, an investigator exploring the barriers to recruitment in clinical research while simultaneously assessing the efficacy of a specific drug in improving outcomes for diabetes will incorporate a strategy to improve the recruitment of an underserved population. In this case, the TS investigator and TR researcher, are both testing the efficacy of a diabetes drug.
However, the key difference is that the TS investigator could be collaborating or only be focusing on addressing challenges in the recruitment processes and optimizing their outcomes.
Additionally, NCATS has a website explaining the translational science principles.
For more information on translational science and scientific and operational principles of translational science, please see
- Advancing translational science education. Faupel-Badger JM, Vogel AL, Austin CP, Rutter JL.Clin Transl Sci. 2022 Nov;15(11):2555-2566. PMID: 36045637.
- Opportunities and Challenges in Translational Science. Christopher P Austin. Clin Transl Sci. 2021 Sep;14(5):1629-1647. PMID: 3398240.