Breaking Down Barriers: Why Diverse Representation in Clinical Research Matters
Diverse representation in clinical research is essential because it ensures that the results of studies are applicable to all members of society, regardless of their ethnicity, gender, age, or other factors. Historically, clinical research has often excluded certain populations, particularly women, minorities, and older adults, which has led to significant gaps in knowledge and unequal access to care.
The BRIC countries and MENA, with a combined population of more than 3 billion, nearly half of the world population, have collectively hosted less than 7 percent of the clinical trials. This lack of representation in clinical research threatens the overarching goals of clinical research.
Lack of Representation Compromising Generalizability of Findings
Clinical research studies that lack representation of certain patient populations can compromise the generalizability of their findings to those populations.
Initially, the results of Randomized Clinical Trials were thought to be broadly applicable to all patient groups. Growing evidence has emerged over the last few decades to put that assumption into doubt. Particularly, research has shown that many marginalized and omitted groups in clinical research can have unique disease manifestations or health conditions that influence how they respond to an investigational medication or treatment.
Ensuring diversified involvement in scientific studies enables the examination of all hereditary and non-genetic variables and their interactions, which is essential for interpretations allowing for generalizability of results to the population.
Lack of representation costs hundreds of billions of dollars
Health disparities resulting from underrepresentation in clinical research can lead to increased healthcare costs overall. For example, if certain populations have higher rates of chronic diseases but are not adequately represented in clinical research, there may be delays in developing effective treatments and interventions, leading to increased healthcare costs associated with managing those chronic diseases.
For example, eliminating all life expectancy disparities for diabetes, hypertension, and heart diseases in under-represented groups in the United States, has a total societal worth of approximately $11 trillion.
As per industry reports, it is expected that depending on the choice of location, cost savings can range from 30 percent to 65 per cent compared to trials conducted within the U.S. or Western Europe.
Lack of representation may hinder innovation
Exploring heterogeneity of treatment effects may be necessary not only to understand variation that affects safety and effectiveness of an intervention in the populations that have been underrepresented in studies but also to identify new biological processes that may, in turn, lead to new discoveries important for all populations.
For example, the discovery of proprotein convertase subtilisin/ Kexin type 9 (PCSK9) has transformed the understanding of cholesterol homeostasis and led to development of important therapeutics for prevention and treatment of atherosclerotic cardiovascular disease.
Lack of representation may compound low accrual that causes many trials to fail
According to an analysis by Global Data (2021), low accrual was the cause for stopping 55 percent of all Phase clinical trials that were terminated, suspended, or discontinued during 2008 - 2017 (and for which a reason was given).
Improving involvement of underrepresented groups is one strategy for increasing enrollment. Thus, increasing the inclusion of underrepresented populations would help to address the number one issue that causes clinical trials to fail, while also ensuring clinical data that is more representative of the entire community that could benefit from a studied intervention.
Lack of representation may lead to lack of access to effective medical interventions
Clinical research is a critical component of developing and testing new medical interventions, including medications, medical devices, and other treatments. Approval and indications for new therapeutics are often restricted to the demographics of the populations included in the clinical studies. Lack of representation may thus impede access to a specific therapeutic agent.