Karina Quiaoit1
1independent, France
Synopsis
Biomedical research routinely produce broad claims about behavior and body function/dysfunctions based on data drawn largely from western, educated, industrialized, rich and democratic communities, often assuming there is little variation across populations, although the highest burden of chronic diseases resides in low-income and low-resourced communities. Neglecting such populations restricts our ability to characterize the full disease spectrum and understand complex disease pathogenesis, further exacerbating disparities across populations. With the introduction of novel imaging technologies aimed at enabling access to neglected populations, it is now time to reimagine inclusive imaging studies and clinical trials to advance discoveries with far reaching implications.
Reengineering to drive diversity in clinical trials
There are several barriers to research participation among communities with low resources [5]. Nonetheless, emerging research design strategies can be leveraged to provide pragmatic solutions that enable participation, even within the current biomedical research landscape and funding mechanisms. In this lecture, I will highlight inclusive strategies that mitigate barriers across levels of participation (individual trial participant, community, researcher, and institution):
- Participant advocacy and integrated knowledge translation (IKT). Enabling patients and caregivers to become stakeholders in the co-creation of a clinical study from design to implementation and dissemination, enhances participation by promoting trust and empowering the individual to meaningfully engage and contribute to the research process. Advocacy and IKT can be in the form of patient/participant testimonials, patient navigators (e.g. Indigenous Patient Navigators of the Cancer Care Ontario program) [6], and co-development of the research (e.q. in the Kidney Clinical Research Unit in southwestern Ontario, patients use their experience in reviewing trial materials)[7]. This strategy minimizes barriers faced by individual trial participants and can be implemented in the research practice and culture of the researchers.
- Community based participatory research (CBPR). Meaningful community engagement of underrepresented communities through CBPR enables open and transparent bilateral collaboration between community members and research institutions. In CBPR, researchers and community members partner and co-learn to effectively address health challenges of that community [8]. A salient example of CBPR is The Lieber Institute for Brain Development (LIBD) African-American Neuroscience Initiative, a partnership of LIBD with the African-American Clergy Medical Research Initiative – a local group of clerics from African-American faith-based communities in Baltimore [9-11]. The LIBD through this CBPR approach built confidence and trust of the local African-American community to increase the brain biobank contribution from African-Americans in Baltimore. The LIBD brain biobank repository currently has the greatest African American donation rate at 60.5% in the US [12].
- Trial Decentralization. Clinical studies are overwhelmingly conducted in urban centers, typically near academic centers where key trial infrastructure are located. Medical imaging technologies are expensive centralized research resource with some like MRI requiring physical-demanding infrastructure and high human capital. Novel very-low field portable MRI devices have enabled imaging research to go to the community (bench-to-community) and be operated in a setting with limited highly trained MRI personnel [13,14]. In Canada, a pilot program is applying a hub and spoke model where a central trial site provides oversight and support to satellite sites to increase access for rural communities [15]. Programs in Australia and the United States are leveraging telemedicine to recruit and enroll trial participants from a wider geographically area and low-resourced communities [16,17]. Similarly, database networks such as the Dementias Platform UK (DPUK), Clinical Biospecimen, Imaging and Gene repository (C-BIG), the UNITED (Uncovering Neurodegenerative Insights Through Ethnic Diversity) Consortium enable centralized data to be openly accessible (decentralized) through resource sharing (expertise, analysis technology, and data) [18,19].
- Targeted Funding and Policy Mechanisms: Through policy and funding, government and funding institutions play a crucial role in enabling research environments to create inclusive clinical trials that reach marginalized populations. For example, funding mechanisms such as special calls by the NIH, the Canadian Institutes of Health Research (CIHR), UK Research and Innovation (UKRI) directed to fund high-quality clinical research focused on disease mechanisms, diagnostics studies and therapeutic interventions in exclusively underrepresented communities can increase clinical data and evidence towards broad understanding of disease mechanisms, manifestations, and diagnostic/treatment implications [20-24].
Conclusion
Fair health care is one of the urgent global health challenges of our time according to the WHO [25]. In the past decade, implications of health inequities not only between rich and poor nations but also among communities within a developed country have become glaringly obvious. Although, this divide arises from several overlapping factors (historical marginalization, socioeconomic, geographical, etc.), most which are not fully understood, emerging approaches and tools to re-engineer clinical trials, from design to implementation, knowledge transfer, and policy can begin to transform health outcomes that benefits all populations.
Many of the tools for pragmatic inclusive clinical trials are already in practice in some medical research groups and institutions. Although, some are highlighted here, it is important to note that no one single solution exists. In general, there is a shared ethical responsibility among all stakeholders (the individual communities, medical researchers, institutions and policy makers) to ensure proportional representation in clinical trials – a necessity for effective and just healthcare. Acknowledgements
No acknowledgement found.References
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